Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT05966493
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2023-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2023-06-20', 'studyFirstSubmitQcDate': '2023-07-21', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achieve Corneal Re-epithelialization Including Durability (CRC)', 'timeFrame': 'End of Study: 28 Days after achieving re-epithelialization', 'description': 'The proportion of subjects achieving corneal re-epithelialization that is maintained for a minimum of 28 days, based on assessment of corneal fluorescein staining images of the PCED by a Central Reading Center (CRC).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PCED', 'Corneal Defect', 'PED'], 'conditions': ['Persistent Corneal Epithelial Defect']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the safety and efficacy of NEXAGON® (lufepirsen ophthalmic gel) (NEXAGON) in subjects with persistent corneal epithelial defects (PCED). The objectives of the study are to evaluate the safety and efficacy of NEXAGON in this population.', 'detailedDescription': 'This study is a randomized, multicenter, double-masked, vehicle-controlled study to evaluate the safety and efficacy of NEXAGON (lufepirsen ophthalmic gel) in subjects with persistent corneal epithelial defects (PCED). The study will enroll subjects who will complete a Screening Period, Treatment Period (up to 8 weeks) and Follow-up Period (4 weeks). Those subjects whose defect has not re-epithelialized by the completion of the Treatment Period or who achieved re-epithelialization but failed to maintain re-epithelialization for 28 days after treatment completion (durability) are eligible to enter the NEXAGON Open-label Treatment Period for an additional 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have a PCED that is at least 2 weeks in duration and refractory to one or more conventional non-surgical standard of care (SOC) treatments\n2. Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatment\n3. Subject must provide written informed consent (or assent)\n4. Subjects with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test\n\nExclusion Criteria:\n\n1. Have a known ocular infection that is deemed to be active requiring therapeutic intervention\n2. Present with a corneal surface defect in either eye that is directly attributed to an infectious etiology (bacterial, viral, fungal and/or protozoal) that has not fully resolved and/or treatment has not been completed\n3. Present with evidence of corneal ulceration/melting involving the posterior third of the stroma and/or perforation in either eye\n4. Have a blepharitis or meibomian gland disease in the study eye that is deemed to be clinically relevant and/or active\n5. Have a history of ocular surgery or any ocular procedure(s) not meeting the designated washout time\n6. Have any other ocular disease requiring topical ocular medication in the affected eye\n7. Have a presence or history of any ocular or systemic disorder or condition that could interfere the safety or efficacy of the study treatment, or the interpretation of the study results\n8. Have a known hypersensitivity to one of the components of the study or procedural medications (e.g., NEXAGON, fluorescein)\n9. Participated in an interventional clinical drug or device trial within 28 days prior to Day 1\n10. Use of the medications presented in the protocol that are prohibited in the study.'}, 'identificationModule': {'nctId': 'NCT05966493', 'acronym': 'NEXPEDE-1', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glaukos Corporation'}, 'officialTitle': 'A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With Persistent Corneal Epithelial Defects (NEXPEDE-1)', 'orgStudyIdInfo': {'id': 'GLK-601-01 (AMB-01-006)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NEXAGON® (lufepirsen ophthalmic gel) High Dose Concentration', 'description': 'Lufepirsen (High dose concentration) applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks.', 'interventionNames': ['Drug: lufepirsen high dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NEXAGON Vehicle (ophthalmic gel)', 'description': 'Vehicle applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks.', 'interventionNames': ['Drug: Vehicle']}, {'type': 'EXPERIMENTAL', 'label': 'NEXAGON® (lufepirsen ophthalmic gel) Low Dose Concentration (EU sites only)', 'description': 'Lufepirsen (Low dose concentration) applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks. (EU sites only).', 'interventionNames': ['Drug: lufepirsen low dose']}], 'interventions': [{'name': 'lufepirsen high dose', 'type': 'DRUG', 'otherNames': ['NEXAGON®'], 'description': 'Lufepirsen is an unmodified connexin43 antisense oligonucleotide.', 'armGroupLabels': ['NEXAGON® (lufepirsen ophthalmic gel) High Dose Concentration']}, {'name': 'Vehicle', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Matching vehicle without lufepirsen.', 'armGroupLabels': ['NEXAGON Vehicle (ophthalmic gel)']}, {'name': 'lufepirsen low dose', 'type': 'DRUG', 'otherNames': ['NEXAGON®'], 'description': 'Lufepirsen is an unmodified connexin43 antisense oligonucleotide.', 'armGroupLabels': ['NEXAGON® (lufepirsen ophthalmic gel) Low Dose Concentration (EU sites only)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36301', 'city': 'Dothan', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '949-739-8749'}], 'facility': 'Glaukos Investigative Site', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '94954', 'city': 'Petaluma', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '949-739-8749'}], 'facility': 'Glaukos Investigative Site', 'geoPoint': {'lat': 38.23242, 'lon': -122.63665}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '949-739-8749'}], 'facility': 'Glaukos Investigative Site', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80924', 'city': 'Colorado Springs', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '949-739-8749'}], 'facility': 'Glaukos Investigative Site', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '81501', 'city': 'Grand Junction', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '949-739-8749'}], 'facility': 'Glaukos Investigative Site', 'geoPoint': {'lat': 39.06387, 'lon': -108.55065}}, {'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '949-739-8749'}], 'facility': 'Glaukos Investigative Site', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33907', 'city': 'Fort Myers', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '949-739-8749'}], 'facility': 'Glaukos Investigative Site', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 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'Mainz', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '949-739-8749'}], 'facility': 'Glaukos Investigative Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '949-739-8749'}], 'facility': 'Glaukos Investigative Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Messina', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '949-739-8749'}], 'facility': 'Glaukos investigative Site', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '949-739-8749'}], 'facility': 'Glaukos Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '949-739-8749'}], 'facility': 'Glaukos Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '949-739-8749'}], 'facility': 'Glaukos Investigative Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Zaragoza', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '949-739-8749'}], 'facility': 'Glaukos Investigative Site', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'centralContacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'ClinicalResearch@Glaukos.com', 'phone': '949-739-8749'}], 'overallOfficials': [{'name': 'Luis G. Vargas, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Glaukos Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaukos Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}