Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT04555694
Status:
COMPLETED
Last Update Posted:
2023-10-11
First Post:
2020-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-29', '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': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D000069559', 'term': 'Loteprednol Etabonate'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tchester@midwestvision.com', 'phone': '440-526-1974', 'title': 'Dr. Thomas Chester, OD', 'organization': 'Cleveland Eye Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline to Week 12', 'eventGroups': [{'id': 'EG000', 'title': 'Restasis and Lotemax', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nLoteprednol Etabonate: Used to treat inflammation of the eye', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Restasis and Dextenza', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nDexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Restasis', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': '2+ Injection at week 8 visit.', 'notes': '2+ injection at week 8 visit. No treatment necessary. Improving upon exit.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Corneal and Conjunctival Staining from Baseline', 'notes': 'Increased corneal and conjunctival staining from baseline to exit visit. No treatment necessary.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Ocular Surface Staining From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Restasis and Lotemax', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nLoteprednol Etabonate: Used to treat inflammation of the eye'}, {'id': 'OG001', 'title': 'Restasis and Dextenza', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nDexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye'}, {'id': 'OG002', 'title': 'Restasis', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 4, Week 8 and Week 12', 'description': 'The primary outcome measure was the mean corneal surface staining (guided by use of fluorescein and lissamine green) at weeks 4, 8 and 12 from baseline based on the National Eye Institute grading scale.\n\nCorneal fluorescein staining was scored from 0 to 3 on the scale (none, better to heavy, worse) in five regions of the cornea and summed for a total score of 0-15.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Mean Conjunctival Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Restasis and Lotemax', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nLoteprednol Etabonate: Used to treat inflammation of the eye'}, {'id': 'OG001', 'title': 'Restasis and Dextenza', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nDexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye'}, {'id': 'OG002', 'title': 'Restasis', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 4, Week 8 and Week 12', 'description': 'The mean conjunctival staining (guided by use of lissamine green) at weeks 4, 8 and 12 from baseline based on the National Eye Institute grading scale.\n\nConjunctival staining was scored from 0 to 3 on the scale (none, better to heavy, worse) in six regions of the cornea and summed for a total score of 0-18.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Mean Schirmer Tear Test 1 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Restasis and Lotemax', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nLoteprednol Etabonate: Used to treat inflammation of the eye'}, {'id': 'OG001', 'title': 'Restasis and Dextenza', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nDexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye'}, {'id': 'OG002', 'title': 'Restasis', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.3', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '14.9', 'spread': '10.3', 'groupId': 'OG001'}, {'value': '11.6', 'spread': '10.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '12.9', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '10.1', 'spread': '8.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '12.4', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '9.4', 'groupId': 'OG001'}, {'value': '10.8', 'spread': '6.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '10.1', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '7.1', 'groupId': 'OG001'}, {'value': '9.6', 'spread': '5.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 4, Week 8 and Week 12', 'description': "Schirmer Tear Test 1 score, measuring tear production, as measured by a Schirmer's test strip with anesthetic (mm/5min on a strip 0-35mm. 0 mm is worse, \\>15 indicates normal production) at week 4, 8 and 12 from Baseline.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Tear Breakup Time (Seconds)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Restasis and Lotemax', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nLoteprednol Etabonate: Used to treat inflammation of the eye'}, {'id': 'OG001', 'title': 'Restasis and Dextenza', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nDexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye'}, {'id': 'OG002', 'title': 'Restasis', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation'}], 'classes': [{'title': 'Basline', 'categories': [{'measurements': [{'value': '5.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '5.7', 'spread': '3.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '6.1', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '3.6', 'groupId': 'OG001'}, {'value': '7.4', 'spread': '3.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '6.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '7.1', 'spread': '3.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '6.1', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '3.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 4, Week 8 and Week 12', 'description': 'The time it takes (in seconds) for the tear film to break after blinking at Week 4, 8 and 12 from Baseline', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Tear Osmolarity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Restasis and Lotemax', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nLoteprednol Etabonate: Used to treat inflammation of the eye'}, {'id': 'OG001', 'title': 'Restasis and Dextenza', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nDexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye'}, {'id': 'OG002', 'title': 'Restasis', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '311.3', 'spread': '19.8', 'groupId': 'OG000'}, {'value': '295.5', 'spread': '17.4', 'groupId': 'OG001'}, {'value': '306.9', 'spread': '28.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '307.7', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '304.4', 'spread': '30.1', 'groupId': 'OG001'}, {'value': '307.9', 'spread': '24.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '300.1', 'spread': '19.2', 'groupId': 'OG000'}, {'value': '303.9', 'spread': '22.1', 'groupId': 'OG001'}, {'value': '295.3', 'spread': '20.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '304.4', 'spread': '28.7', 'groupId': 'OG000'}, {'value': '299.5', 'spread': '16.2', 'groupId': 'OG001'}, {'value': '304.6', 'spread': '19.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 4, Week 8 and Week 12', 'description': 'Tear osmolarity as measured by TearLab (275-307 is considered "homeostatic range") at Week 4, 8 and 12 from Baseline.', 'unitOfMeasure': 'mOsM/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Meibomian Gland Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Restasis and Lotemax', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nLoteprednol Etabonate: Used to treat inflammation of the eye'}, {'id': 'OG001', 'title': 'Restasis and Dextenza', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nDexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye'}, {'id': 'OG002', 'title': 'Restasis', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.1', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '9.2', 'spread': '2.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '6.7', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '7.2', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '6.3', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '8.2', 'spread': '2.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '6.0', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '1.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 4, Week 8 and Week 12', 'description': 'Meibomian gland scoring on a scale of 1-4 (1 represents clear, liquid secretions and 4 is no secretions) in three regions (nasal, central, temporal) and summed for a single score between 3-12 at Week 4, 8 and 12 from baseline', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'DEQ-5 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Restasis and Lotemax', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nLoteprednol Etabonate: Used to treat inflammation of the eye'}, {'id': 'OG001', 'title': 'Restasis and Dextenza', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nDexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye'}, {'id': 'OG002', 'title': 'Restasis', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '14.4', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '4.0', 'groupId': 'OG001'}, {'value': '14.4', 'spread': '3.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '11.0', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '4.6', 'groupId': 'OG001'}, {'value': '12.2', 'spread': '2.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '9.1', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '2.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '10.2', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '9.4', 'spread': '3.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 4, Week 8 and Week 12', 'description': 'Dry Eye Questionnaire-5 (5 questions about dry eye symptoms rated from 0, or never to 5, or constantly) total score of 0-22 with higher scores representing worse symptoms at weeks 4, 8 and 12 from baseline', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Restasis and Lotemax', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nLoteprednol Etabonate: Used to treat inflammation of the eye'}, {'id': 'FG001', 'title': 'Restasis and Dextenza', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nDexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye'}, {'id': 'FG002', 'title': 'Restasis', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '20', 'numSubjects': '10'}, {'groupId': 'FG001', 'numUnits': '20', 'numSubjects': '10'}, {'groupId': 'FG002', 'numUnits': '20', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '20', 'numSubjects': '10'}, {'groupId': 'FG001', 'numUnits': '20', 'numSubjects': '10'}, {'groupId': 'FG002', 'numUnits': '20', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Eyes', 'preAssignmentDetails': 'Thirty patients were enrolled in the study. 10 patients in each treatment group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Restasis and Lotemax', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nLoteprednol Etabonate: Used to treat inflammation of the eye'}, {'id': 'BG001', 'title': 'Restasis and Dextenza', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation\n\nDexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert: Used to treat inflammation of the eye'}, {'id': 'BG002', 'title': 'Restasis', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes\n\nCyclosporine: Used to increase tear production in patients who have dry eye caused by inflammation'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '44', 'upperLimit': '72'}, {'value': '55', 'groupId': 'BG001', 'lowerLimit': '32', 'upperLimit': '78'}, {'value': '62', 'groupId': 'BG002', 'lowerLimit': '43', 'upperLimit': '79'}, {'value': '58', 'groupId': 'BG003', 'lowerLimit': '32', 'upperLimit': '79'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-11', 'size': 3305495, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-08T10:52', 'hasProtocol': True}, {'date': '2022-06-05', 'size': 667001, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-06-08T10:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '10 subjects will receive Restasis and Dextenza 10 subjects will receive Restasis and Lotemax 10 subjects will receive Restasis'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-18', 'studyFirstSubmitDate': '2020-09-14', 'resultsFirstSubmitDate': '2023-06-08', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-18', 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Ocular Surface Staining From Baseline', 'timeFrame': 'Baseline to Week 4, Week 8 and Week 12', 'description': 'The primary outcome measure was the mean corneal surface staining (guided by use of fluorescein and lissamine green) at weeks 4, 8 and 12 from baseline based on the National Eye Institute grading scale.\n\nCorneal fluorescein staining was scored from 0 to 3 on the scale (none, better to heavy, worse) in five regions of the cornea and summed for a total score of 0-15.'}], 'secondaryOutcomes': [{'measure': 'Mean Conjunctival Staining', 'timeFrame': 'Baseline to Week 4, Week 8 and Week 12', 'description': 'The mean conjunctival staining (guided by use of lissamine green) at weeks 4, 8 and 12 from baseline based on the National Eye Institute grading scale.\n\nConjunctival staining was scored from 0 to 3 on the scale (none, better to heavy, worse) in six regions of the cornea and summed for a total score of 0-18.'}, {'measure': 'Mean Schirmer Tear Test 1 Score', 'timeFrame': 'Baseline to Week 4, Week 8 and Week 12', 'description': "Schirmer Tear Test 1 score, measuring tear production, as measured by a Schirmer's test strip with anesthetic (mm/5min on a strip 0-35mm. 0 mm is worse, \\>15 indicates normal production) at week 4, 8 and 12 from Baseline."}, {'measure': 'Tear Breakup Time (Seconds)', 'timeFrame': 'Baseline to Week 4, Week 8 and Week 12', 'description': 'The time it takes (in seconds) for the tear film to break after blinking at Week 4, 8 and 12 from Baseline'}, {'measure': 'Tear Osmolarity', 'timeFrame': 'Baseline to Week 4, Week 8 and Week 12', 'description': 'Tear osmolarity as measured by TearLab (275-307 is considered "homeostatic range") at Week 4, 8 and 12 from Baseline.'}, {'measure': 'Meibomian Gland Scores', 'timeFrame': 'Baseline to Week 4, Week 8 and Week 12', 'description': 'Meibomian gland scoring on a scale of 1-4 (1 represents clear, liquid secretions and 4 is no secretions) in three regions (nasal, central, temporal) and summed for a single score between 3-12 at Week 4, 8 and 12 from baseline'}, {'measure': 'DEQ-5 Score', 'timeFrame': 'Baseline to Week 4, Week 8 and Week 12', 'description': 'Dry Eye Questionnaire-5 (5 questions about dry eye symptoms rated from 0, or never to 5, or constantly) total score of 0-22 with higher scores representing worse symptoms at weeks 4, 8 and 12 from baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'This 6 month study seeks to compare the use of Intracanalicular Dexamethasone in conjunction with Restasis (cyclosporine ophthalmic emulsion) for the treatment of signs and symptoms of dry eye disease as compared to Restasis with Lotemax (loteprednol etabonate ophthalmic suspension 0.5%) and Restasis monotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Signs and symptoms of Dry Eye Disease\n* Consent to treat with topical immunomodulator\n* Willing and able to comply with clinic visits and study related procedures\n* Willing and able to sign the informed consent form\n\nExclusion Criteria:\n\n* Patients under the age of 18.\n* Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)\n* Active infectious systemic disease\n* Active infectious ocular or extraocular disease\n* Altered nasolacrimal flow of either acquired, induced, or congenital origin\n* Hypersensitivity to dexamethasone\n* Patients who have been on topical immunomodulating agents in the previous 3 months to their baseline visit\n* Patient being treated with either topical, oral, or intravenous immunosuppressive agents, immunomodulating agents, or steroid (including NSAIDS)\n* Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator'}, 'identificationModule': {'nctId': 'NCT04555694', 'briefTitle': 'Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax', 'organization': {'class': 'OTHER', 'fullName': 'Cleveland Eye Clinic'}, 'officialTitle': 'Intracanalicular Dexamethasone Used in Conjunction With Restasis (Cyclosporine Ophthalmic Emulsion) for the Treatment of Signs and Symptoms of Dry Eye Disease as Compared to Restasis With Lotemax (Loteprednol Etabonate Ophthalmic Suspension 0.5%) and Restasis Monotherapy.', 'orgStudyIdInfo': {'id': 'TC-2020-DexRes'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Restasis and Lotemax', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.', 'interventionNames': ['Drug: Cyclosporine', 'Drug: Loteprednol Etabonate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Restasis and Dextenza', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.', 'interventionNames': ['Drug: Cyclosporine', 'Drug: Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Restasis', 'description': '10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes', 'interventionNames': ['Drug: Cyclosporine']}], 'interventions': [{'name': 'Cyclosporine', 'type': 'DRUG', 'otherNames': ['Restasis'], 'description': 'Used to increase tear production in patients who have dry eye caused by inflammation', 'armGroupLabels': ['Restasis', 'Restasis and Dextenza', 'Restasis and Lotemax']}, {'name': 'Loteprednol Etabonate', 'type': 'DRUG', 'otherNames': ['Lotemax'], 'description': 'Used to treat inflammation of the eye', 'armGroupLabels': ['Restasis and Lotemax']}, {'name': 'Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert', 'type': 'DRUG', 'otherNames': ['Dextenza'], 'description': 'Used to treat inflammation of the eye', 'armGroupLabels': ['Restasis and Dextenza']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44141', 'city': 'Brecksville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Eye Clinic', 'geoPoint': {'lat': 41.31978, 'lon': -81.62679}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Chester, OD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Thomas Chester, OD', 'investigatorAffiliation': 'Cleveland Eye Clinic'}}}}