Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-29 @ 4:38 PM
Study NCT ID:
NCT04498468
Status:
TERMINATED
Last Update Posted:
2024-03-15
First Post:
2020-07-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza®) in the Management of Clinically Significant Dry Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D000070635', 'term': 'Punctal Plugs'}], 'ancestors': [{'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mlin60@jhu.edu', 'phone': '8653851192', 'title': 'Michael Lin, BA, Research coordinator', 'organization': 'Johns Hopkins Wilmer Eye Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was not able to enroll its planned sample size. VAS, while consistently used in measuring clinical symptoms of illnesses, is limited in that patients may encounter difficulties in rating their symptomology, especially if the participants feel ambivalent towards the VAS prompts.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 42 days', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Arm', 'description': 'Treatment:\n\nCommercially available Sustained Release Dexamethasone, 0.4 mg intracannalicular insert (DEXTENZA® - Ocular Therapeutix, Bedford, MA) Sustained Release Dexamethasone, 0.4 mg: dexamethasone 0.4mg lacrimal insert', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 19, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Control Arm', 'description': 'Control:\n\nFCIProlong® made of E-Caprolactone-L-Lactide copolymer (PCL) (FCI Ophthalmics Inc., Pembroke, MA) E-Caprolactone-L-Lactide copolymer (PCL) punctal plug: Control eye will receive a tear duct plug without the dexamethasone (EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL). Absorbs in 60 to 180 days. Size 0.5mm which is comparable to the study treatment)', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 10, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Week 6: Raised intraocular pressure (increase by 5-10 mm Hg from baseline)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Week 6: Raised intraocular pressure (increase by >10 mm Hg from baseline)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Week 6: Worsening of Corneal Fluorescein staining (increase by ≥2 from baseline)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Week 6: Worsening of conjunctival lissamine green staining (increase by ≥2 from baseline)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Day 14', 'notes': 'On 7/7/22, patient saw her neurosurgeon and was diagnosed with "high-grade glioma" and offered surgery, radiation, and chemotherapy. PI and pt. jointly decided to withdraw study consent in order for patient to focus on post neurosurgical recovery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 77, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy Endpoint as Assessed by Dry Eye Sign Using Ocular Surface Scale (OSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Commercially available Sustained Release Dexamethasone, 0.4 mg intracannalicular insert (DEXTENZA® - Ocular Therapeutix, Bedford, MA)\n\nSustained Release Dexamethasone, 0.4 mg: dexamethasone 0.4mg lacrimal insert'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'FCIProlong® made of E-Caprolactone-L-Lactide copolymer (PCL) (FCI Ophthalmics Inc., Pembroke, MA)\n\nE-Caprolactone-L-Lactide copolymer (PCL) punctal plug: Control eye will receive a tear duct plug without the dexamethasone (EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL). Absorbs in 60 to 180 days. Size 0.5mm which is comparable to the study treatment)'}], 'classes': [{'title': 'Day 28 Corneal Staining Mean Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.15', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '2.70', 'spread': '1.33', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 Corneal Staining Mean Staining - Subgroup 18-59', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.14', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '2.64', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 Corneal Staining Mean Staining - Subgroup 60+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.13', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '3.06', 'spread': '1.12', 'groupId': 'OG001'}]}]}, {'title': "Day 28 Corneal Staining Subgroup analysis by Sjögren's status - Yes", 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.54', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '3.23', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': "Day 28 Corneal Staining Subgroup analysis by Sjögren's status - No", 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.82', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '2.59', 'spread': '1.23', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 Conjunctival Staining Mean Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.01', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '3.69', 'spread': '1.69', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 Conjunctival Staining Mean Staining - Subgroup 18-59', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.50', 'spread': '2.35', 'groupId': 'OG000'}, {'value': '2.69', 'spread': '1.89', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 Conjunctival Staining Mean Staining - Subgroup 60+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.69', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '3.88', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': "Day 28 Conjunctival Staining Subgroup analysis by Sjögren's status - Yes", 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.31', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '4.09', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': "Day 28 Conjunctival Staining Subgroup analysis by Sjögren's status - No", 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.88', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '3.59', 'spread': '1.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '-0.19', 'groupDescription': 'Corneal staining analysis, day 28.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-1.28', 'ciUpperLimit': '0.28', 'groupDescription': 'Corneal staining sub-group analysis, day 28, 18-59 year old subgroup.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.94', 'ciLowerLimit': '-1.86', 'ciUpperLimit': '-0.02', 'groupDescription': 'Corneal staining sub-group analysis, day 28, 60+ year old subgroup.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.69', 'ciLowerLimit': '-1.49', 'ciUpperLimit': '0.10', 'groupDescription': "Corneal staining sub-group analysis, day 28, Sjogren's subgroup.", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.77', 'ciLowerLimit': '-1.67', 'ciUpperLimit': '0.14', 'groupDescription': "Corneal staining sub-group analysis, day 28, non-Sjogren's subgroup.", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.68', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '-0.30', 'groupDescription': 'Conjunctival staining analysis, day 28', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '0.61', 'groupDescription': 'Conjunctival staining sub-group analysis, day 28, 18-59 year old subgroup.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.19', 'ciLowerLimit': '-2.17', 'ciUpperLimit': '-0.21', 'groupDescription': 'Conjunctival staining sub-group analysis, day 28, 60+ year old subgroup.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.77', 'ciLowerLimit': '-1.88', 'ciUpperLimit': '0.34', 'groupDescription': "Conjunctival staining sub-group analysis, day 28, Sjogren's subgroup.", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.097', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '0.14', 'groupDescription': "Conjunctival staining sub-group analysis, day 28, non-Sjogren's subgroup.", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': "OSS will be graded according to the Sjögren's International Collaborative Clinical Alliance (SICCA) grading system. Maximum possible fluorescein score (the punctate epithelial erosions grade + any extra points for modifiers \\[central staining, confluent staining, and filaments\\]) will be 6 and minimum of 0. Maximum possible conjunctival staining score (the punctate epithelial erosions grade on the temporal and nasal sides) will be 6 and minimum of 0. The total possible maximum OSS, derived by summing the corneal and conjunctival scores, will be 12 for each eye, and minimum OSS will be 0. Higher corneal, conjunctival, and staining scores represent worse outcomes.\n\nThe difference between the average corneal staining in the treated arm versus the average corneal staining in the sham arm will be compared statistically.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': "Only 75 (150 eyes) patients' data were analyzed as 2 patients were lost to follow-up before 28 days."}, {'type': 'PRIMARY', 'title': 'Patient Reported Symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Commercially available Sustained Release Dexamethasone, 0.4 mg intracannalicular insert (DEXTENZA® - Ocular Therapeutix, Bedford, MA)\n\nSustained Release Dexamethasone, 0.4 mg: dexamethasone 0.4mg lacrimal insert'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'FCIProlong® made of E-Caprolactone-L-Lactide copolymer (PCL) (FCI Ophthalmics Inc., Pembroke, MA)\n\nE-Caprolactone-L-Lactide copolymer (PCL) punctal plug: Control eye will receive a tear duct plug without the dexamethasone (EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL). Absorbs in 60 to 180 days. Size 0.5mm which is comparable to the study treatment)'}], 'classes': [{'title': 'Day 28 Eye Dryness VAS Mean Score', 'categories': [{'measurements': [{'value': '49.3', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '54.8', 'spread': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 Eye Discomfort VAS Mean Score', 'categories': [{'measurements': [{'value': '50.3', 'spread': '27.7', 'groupId': 'OG000'}, {'value': '50.6', 'spread': '26.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 Eye Fatigue VAS Mean Score', 'categories': [{'measurements': [{'value': '43.7', 'spread': '27.5', 'groupId': 'OG000'}, {'value': '45.0', 'spread': '26.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.069', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.5', 'ciLowerLimit': '-11.4', 'ciUpperLimit': '0.4', 'groupDescription': 'Eye dryness, day 28', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-7.0', 'ciUpperLimit': '6.3', 'groupDescription': 'VAS Eye discomfort, Day 28', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '3.1', 'groupDescription': 'VAS eye fatigue, day 28', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '28 Days', 'description': '(1)eye dryness, (2)eye discomfort, or (3)eye fatigue will be measured using visual analogue scale (0 to 100). The difference between the average bothersome symptom in the treated arm versus the average most bothersome symptom in the sham arm will be compared statistically. Higher VAS scores indicate worse eye dryness, discomfort, or fatigue.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': "Only 75 (150 eyes) patients' data were analyzed as 2 patients were lost to follow-up before 28 days."}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving 2 Severity Grade Improvement in Corneal Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Commercially available Sustained Release Dexamethasone, 0.4 mg intracannalicular insert (DEXTENZA® - Ocular Therapeutix, Bedford, MA)\n\nSustained Release Dexamethasone, 0.4 mg: dexamethasone 0.4mg lacrimal insert'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'FCIProlong® made of E-Caprolactone-L-Lactide copolymer (PCL) (FCI Ophthalmics Inc., Pembroke, MA)\n\nE-Caprolactone-L-Lactide copolymer (PCL) punctal plug: Control eye will receive a tear duct plug without the dexamethasone (EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL). Absorbs in 60 to 180 days. Size 0.5mm which is comparable to the study treatment)'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.42', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '0.8', 'ciUpperLimit': '2.0', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '42 days', 'description': 'Corneal staining responder analysis. Responder is defined as two full severity grade improvement in corneal staining. The percentage of subjects achieving two severity grades improvement in corneal staining (responders) in the treated arm versus sham arm will be compared statistically.', 'unitOfMeasure': 'Percentage of responders', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': "74 (148 eyes) patients' data were analyzed as 3 patients were lost to follow-up before 42 days."}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Improvement in Their Most Bothersome Symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Commercially available Sustained Release Dexamethasone, 0.4 mg intracannalicular insert (DEXTENZA® - Ocular Therapeutix, Bedford, MA)\n\nSustained Release Dexamethasone, 0.4 mg: dexamethasone 0.4mg lacrimal insert'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'FCIProlong® made of E-Caprolactone-L-Lactide copolymer (PCL) (FCI Ophthalmics Inc., Pembroke, MA)\n\nE-Caprolactone-L-Lactide copolymer (PCL) punctal plug: Control eye will receive a tear duct plug without the dexamethasone (EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL). Absorbs in 60 to 180 days. Size 0.5mm which is comparable to the study treatment)'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.42', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '42 days', 'description': 'Symptom responder analysis. Responder is defined as 30% or more improvement in the most bothersome symptom (VAS score is decreased by 30 points or more). The percentage of subjects achieving a 30% improvement in their most bothersome symptom (responders) in the treated arm versus the sham arm will be compared statistically.', 'unitOfMeasure': 'Percentage of responders', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': "74 (148 eyes) patients' data were analyzed as 3 patients were lost to follow-up before 42 days."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Intraocular Pressure Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Commercially available Sustained Release Dexamethasone, 0.4 mg intracannalicular insert (DEXTENZA® - Ocular Therapeutix, Bedford, MA)\n\nSustained Release Dexamethasone, 0.4 mg: dexamethasone 0.4mg lacrimal insert'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'FCIProlong® made of E-Caprolactone-L-Lactide copolymer (PCL) (FCI Ophthalmics Inc., Pembroke, MA)\n\nE-Caprolactone-L-Lactide copolymer (PCL) punctal plug: Control eye will receive a tear duct plug without the dexamethasone (EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL). Absorbs in 60 to 180 days. Size 0.5mm which is comparable to the study treatment)'}], 'classes': [{'title': 'Day 30 : Raised intraocular pressure (increase by 5-10 mm Hg from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 30 : Raised intraocular pressure (increase by >10 mm Hg from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 42 : Raised intraocular pressure (increase by 5-10 mm Hg from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Day 42 : Raised intraocular pressure (increase by >10 mm Hg from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At day 30 and day 42', 'description': 'Intraocular Pressure (IOP) measurement obtained using applanation tonometry', 'unitOfMeasure': 'percentage of subjects with IOP increase', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': "75 (150 eyes) patients' data were analyzed at day 30. 74 (148 eyes) patients' data were analyzed at day 42."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'All participants received treatment and control.\n\nTreatment:\n\nCommercially available Sustained Release Dexamethasone, 0.4 mg intracannalicular insert (DEXTENZA® - Ocular Therapeutix, Bedford, MA) Sustained Release Dexamethasone, 0.4 mg: dexamethasone 0.4mg lacrimal insert\n\nControl:\n\nFCIProlong® made of E-Caprolactone-L-Lactide copolymer (PCL) (FCI Ophthalmics Inc., Pembroke, MA) E-Caprolactone-L-Lactide copolymer (PCL) punctal plug: Control eye will receive a tear duct plug without the dexamethasone (EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL). Absorbs in 60 to 180 days. Size 0.5mm which is comparable to the study treatment)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Patients received both the treatment arm and the control arm - the eye that received the treatment was randomized. 77 participants, and thus 154 eyes, enrolled.', 'groupId': 'FG000', 'numUnits': '154', 'numSubjects': '77'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': "2 patients were lost to follow-up. 1 patient did not complete their week 6 visit. All patients lost to follow-up were followed in PI's primary care post-study. Patients received both the treatment arm and the control arm - the eye that received the treatment was randomized. 74 participants, and thus 148 eyes, completed.", 'groupId': 'FG000', 'numUnits': '148', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'typeUnitsAnalyzed': 'eyes', 'recruitmentDetails': 'Single-center, participant- and outcome assessor-masked, randomized controlled trial at the Ocular Surface Disease Clinic of Wilmer Eye Institute, The Johns Hopkins University School of Medicine in Baltimore, Maryland, USA.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}]}, {'units': 'eyes', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'All participants received treatment and control.\n\nTreatment:\n\nCommercially available Sustained Release Dexamethasone, 0.4 mg intracannalicular insert (DEXTENZA® - Ocular Therapeutix, Bedford, MA) Sustained Release Dexamethasone, 0.4 mg: dexamethasone 0.4mg lacrimal insert\n\nControl:\n\nFCIProlong® made of E-Caprolactone-L-Lactide copolymer (PCL) (FCI Ophthalmics Inc., Pembroke, MA) E-Caprolactone-L-Lactide copolymer (PCL) punctal plug: Control eye will receive a tear duct plug without the dexamethasone (EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL). Absorbs in 60 to 180 days. Size 0.5mm which is comparable to the study treatment)'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age Categories of Participants', 'categories': [{'title': '18-29 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '30-39 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '40-49 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '50-59 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': '60-69 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': '70-79 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '80 years or older', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Posterior Blepharitis', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Visually Significant Cataract', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Anterior Blepharitis', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Punctal plugs', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': "Sjögren's", 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Pseudophakia', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Conjunctival Scarring/Punctal stenosis', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Corneal Haze/Scarring', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Corneal Vascularization', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'History of Corneal Ulceration', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'eyes', 'populationDescription': "Only 75 (150 eyes) patients' data were analyzed at baseline as 2 patients were lost to follow-up before week 4."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-21', 'size': 394287, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-04T11:46', 'hasProtocol': True}, {'date': '2021-05-02', 'size': 1032935, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-12-04T11:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient and the examining physician/outcomes accessor will be masked. The treating physician cannot be masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, Double Masked, Interventional Study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'whyStopped': 'The study was terminated prematurely due to administrative reasons; loss of several research personnel. Because of strict eligibility criteria, the investigators anticipated delays in completing enrollment and therefore decided to terminate early.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2020-07-28', 'resultsFirstSubmitDate': '2024-01-16', 'studyFirstSubmitQcDate': '2020-08-03', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-13', 'studyFirstPostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Intraocular Pressure Increase', 'timeFrame': 'At day 30 and day 42', 'description': 'Intraocular Pressure (IOP) measurement obtained using applanation tonometry'}], 'primaryOutcomes': [{'measure': 'Efficacy Endpoint as Assessed by Dry Eye Sign Using Ocular Surface Scale (OSS)', 'timeFrame': '28 days', 'description': "OSS will be graded according to the Sjögren's International Collaborative Clinical Alliance (SICCA) grading system. Maximum possible fluorescein score (the punctate epithelial erosions grade + any extra points for modifiers \\[central staining, confluent staining, and filaments\\]) will be 6 and minimum of 0. Maximum possible conjunctival staining score (the punctate epithelial erosions grade on the temporal and nasal sides) will be 6 and minimum of 0. The total possible maximum OSS, derived by summing the corneal and conjunctival scores, will be 12 for each eye, and minimum OSS will be 0. Higher corneal, conjunctival, and staining scores represent worse outcomes.\n\nThe difference between the average corneal staining in the treated arm versus the average corneal staining in the sham arm will be compared statistically."}, {'measure': 'Patient Reported Symptom', 'timeFrame': '28 Days', 'description': '(1)eye dryness, (2)eye discomfort, or (3)eye fatigue will be measured using visual analogue scale (0 to 100). The difference between the average bothersome symptom in the treated arm versus the average most bothersome symptom in the sham arm will be compared statistically. Higher VAS scores indicate worse eye dryness, discomfort, or fatigue.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Achieving 2 Severity Grade Improvement in Corneal Staining', 'timeFrame': '42 days', 'description': 'Corneal staining responder analysis. Responder is defined as two full severity grade improvement in corneal staining. The percentage of subjects achieving two severity grades improvement in corneal staining (responders) in the treated arm versus sham arm will be compared statistically.'}, {'measure': 'Percentage of Subjects Achieving Improvement in Their Most Bothersome Symptom', 'timeFrame': '42 days', 'description': 'Symptom responder analysis. Responder is defined as 30% or more improvement in the most bothersome symptom (VAS score is decreased by 30 points or more). The percentage of subjects achieving a 30% improvement in their most bothersome symptom (responders) in the treated arm versus the sham arm will be compared statistically.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ocular surface disease', 'dexamethasone', 'ophthalmic steroids', 'keratoconjuntivitis sicca', 'dry eye'], 'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'To determine efficacy and safety profile of dexamethasone 0.4mg lacrimal insert in dry eye related ocular surface inflammation.', 'detailedDescription': 'Previous studies showed that dexamethasone and loteprednol topical drops have led to favorable results. However, the requirement of frequent instillation of drops by the patients is problematic causing discomfort and blurring of vision and requires remembering and dexterity for instillation, poor compliance is not uncommon. In addition Investigators believe that instillation of drops disturbs the homeostasis of the natural tear film due to physical and chemical trauma due to large drop volume (50 microliters) hammering on the eye surface (which can only hold 7 to 10 microliters). Particularly washing away of the mucin layer that holds all the "good ingredients" in the tears is harmful to the ocular surface. Therefore, "dropless" treatment of dry eye is desirable.\n\nDextenza® (dexamethasone ophthalmic insert, Ocular Therapeutix Inc., Bedford, MA) is a corticosteroid intracanalicular insert approved by US-FDA in November 2018 for the treatment of post-surgical ocular inflammation and pain. It is inserted into the lower lacrimal punctum and into the canaliculus. A single insert releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion. Dextenza® is resorbable and does not require removal. Investigators hypothesize that Dextenza® could mimic short-term topical steroid use in a tapering manner in patients with clinically significant dry eye and show efficacy in improving its symptoms and signs, as was previously shown with other steroid preparations. If proven, the use of Dextenza® may shift paradigms in the management of the clinically significant ocular surface disease. To test this hypothesis, investigators propose to study the effects of Dextenza® in the treatment of clinically significant dry eye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nA patient's study eye must meet the following criteria to be eligible for inclusion in the study:\n\n* Male or Female Age 18-100\n* Capacity to give informed consent\n* Ability to follow study direction and complete all study visits\n* A previous or current diagnosis of dry eye by an eye care specialist, whereas treatment is requiring the use of a topical steroid\n* Able to have a lacrimal plug placement into both lower puncta. If lower puncta are already plugged or cauterized/sealed, upper puncta will be used\n* Females of childbearing potential unwilling to use reliable form(s) of birth control throughout study period\n* Clinical diagnosis of dry eye syndrome (DES) or keratoconjunctivitis sicca (KCS), in which the following has been bilaterally documented in the ophthalmic and medical histories:\n\n i. history/diagnosis of dry eye ii. has taken or is on prescription drops (including but not limited to topical steroids, cyclosporine or lifitegrast)\n* Presence of all of the following in both eyes at Baseline (Day 1):\n\n i. Total OSS of 3 or more with at least 2+ corneal staining (0-6) ii. Unanesthetized Schirmer level of \\<10 mm at 5 minutes iii. Presence of significant symptoms defined as 30mm or higher score of (1) eye dryness, or (2) eye fatigue, or (3) eye discomfort as measured using VAS, in both eyes. At the baseline visit, the most bothersome symptom (of the three) will be determined and used as the main symptom outcome measure throughout the study.\n\nExclusion Criteria:\n\nA patient who meets any of the following criteria will be excluded from the study:\n\n* Use of Contact lenses within 1 week of screening visit or during the study\n* Any ocular surgery (including tear duct cauterization) within the 3 months\n* Inability to place a lacrimal device into upper or lower puncta of both eyes (if upper in R eye should be upper in the left eye and vice versa)\n* Inability to participate in the wash out period\n* Use of topical glaucoma medications (With exception of rescue medication)\n* Pregnancy, nursing or intention of pregnancy or nursing in the study period.\n* Monocular patients\n* Uncontrolled systemic disease (defined as frequent or recent change in the medication regimen)\n* Patients who are currently on with stable doses of oral steroids, topical cyclosporine or lifitigrast, topical tacrolimus or pimecrolimus are eligible as long as there has been no change in the dose in the last 3 months\n* Patients who are on topical steroids (With exception of rescue medication) (Patients who have used steroids recently but have been off for at least 2 weeks will be eligible.)\n* Current enrollment in any other investigational drug or device study or participation of study within 30 days of baseline visit.\n* Known allergy or sensitivity to any of the clinical or experimental drugs used in this study including history of steroid response."}, 'identificationModule': {'nctId': 'NCT04498468', 'briefTitle': 'Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza®) in the Management of Clinically Significant Dry Eye', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza®) in the Management of Clinically Significant Dry Eye', 'orgStudyIdInfo': {'id': 'IRB00246348'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'Commercially available Sustained Release Dexamethasone, 0.4 mg intracannalicular insert (DEXTENZA® - Ocular Therapeutix, Bedford, MA)', 'interventionNames': ['Drug: Sustained Release Dexamethasone, 0.4 mg']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Arm', 'description': 'Commercially available EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL) (Vera90™ - Elkridge, MD)', 'interventionNames': ['Other: E-Caprolactone-L-Lactide copolymer (PCL) punctal plug']}], 'interventions': [{'name': 'Sustained Release Dexamethasone, 0.4 mg', 'type': 'DRUG', 'otherNames': ['Dextenza'], 'description': 'dexamethasone 0.4mg lacrimal insert', 'armGroupLabels': ['Treatment Arm']}, {'name': 'E-Caprolactone-L-Lactide copolymer (PCL) punctal plug', 'type': 'OTHER', 'otherNames': ['EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG'], 'description': 'Control eye will receive a tear duct plug without the dexamethasone (EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL). Absorbs in 60 to 180 days. Size 0.5mm which is comparable to the study treatment)', 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Wilmer Eye Institute, Johns Hopkins School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Esen Akpek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Aggregated information only will be shared with sponsor'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}