Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-25 @ 2:24 PM
Study NCT ID:
NCT06133166
Status:
UNKNOWN
Last Update Posted:
2023-11-18
First Post:
2023-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study for the Treatment of Dry Eye in Postmenopausal Women
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': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-08-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-17', 'studyFirstSubmitDate': '2023-11-03', 'studyFirstSubmitQcDate': '2023-11-09', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tCFS', 'timeFrame': '8 weeks', 'description': 'Change from baseline in tCFS（Total corneal fluorescein staining）after 8-week of treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postmenopausal Women With DED']}, 'descriptionModule': {'briefSummary': 'A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of EG017 Ointment for the Treatment of Dry Eye in Postmenopausal Women', 'detailedDescription': 'To evaluate the efficacy and safety of EG017 ointment for the treatment of DED in postmenopausal women'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years old；\n2. Postmenopausal women\n3. Diagnosed with DED for at least 6 months;\n4. If receiving artificial tears for DED, discontinue use 1 day prior to baseline exam; if receiving other topical medications for DED, discontinue use more than 1 week or 5 half-lives (whichever is longer) prior to baseline exam; willing to discontinue use of any other topical medication for DED other than artificial tears for the entire study period;\n\n6） Voluntarily participate in the trial, understand and sign written informed consent, and be willing and able to comply with the clinical trial arrangements\n\nExclusion Criteria:\n\n1. Presence of a history of allergic reactions to the study drug, similar drugs or ingredients;\n2. DED secondary to scar formation (e.g., radiation therapy, alkali burns, Stevens-Johnson syndrome, scar-like aspergillosis) or conjunctival cupped cell destruction (e.g., vitamin A deficiency);\n3. Screening slit lamp examinations reveal clinically significant ocular disease or abnormalities in the ocular anatomy\n4. Schirmer test (without anesthesia) \\< 3mm/5min；\n5. Screening stage CFS revealed a lamellar defect in the corneal epithelium or ≥ 2 areas of corneal staining fusion \\> 50%;\n6. BCVA ≤ 0.2 in both eyes during the screening period;\n7. Presence of active ocular or periocular acne, ocular allergies and ocular infections at the time of screening, which in the judgment of the investigator may interfere with the test;\n8. History of corneal contact lens wear within 1 month prior to screening, or inability to stop wearing corneal contact lenses during the screening period to the end of the study;\n9. History of treatment with topical steroids, topical NSAIDs, topical cyclosporine, lifitegrast, tacrolimus, serum tears, or topical antiglaucoma medications within 1 month prior to screening;\n10. Have received or had removed a permanent lacrimal embolus within 1 month prior to screening, or plan to have a lacrimal embolus installed or related to removal of a lacrimal embolus during the study, or plan to have a lacrimal embolus lysed during the study;\n11. LipiFlow treatment within 3 months prior to screening, or intense pulsed light treatment within 1 month prior to screening, or blepharoplasty within 1 week prior to screening;\n12. History of intraocular surgery or ocular laser surgery within 6 months prior to screening, or planned ocular or eyelid surgery during the study period;\n13. Presence of a history of herpetic keratitis, ocular or periocular malignancy;\n14. Presence of an infection requiring systemic antibiotic (including antibacterial, antiviral, antifungal) control within 7 days prior to screening;\n15. Severe systemic autoimmune diseases;\n16. Presence of the clinically significant diseases；\n17. Participated in other drug or device clinical trials within 1 month prior to screening;\n18. Any medical or other condition that the investigator believes may affect the clinical trial.'}, 'identificationModule': {'nctId': 'NCT06133166', 'briefTitle': 'A Study for the Treatment of Dry Eye in Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Changchun GeneScience Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of EG017 Ointment for the Treatment of Dry Eye in Postmenopausal Women', 'orgStudyIdInfo': {'id': 'GenSci100-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EG017 ointment 3%', 'description': '60 subjects，Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks', 'interventionNames': ['Drug: EG017 ointment']}, {'type': 'EXPERIMENTAL', 'label': 'EG017 ointment 5%', 'description': '60 subjects，Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks', 'interventionNames': ['Drug: EG017 ointment']}, {'type': 'EXPERIMENTAL', 'label': 'EG017 ointment 9%', 'description': '60 subjects，Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks', 'interventionNames': ['Drug: EG017 ointment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo A', 'description': '40 subjects，Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks', 'interventionNames': ['Drug: EG017 ointment placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo B', 'description': '20 subjects，Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks', 'interventionNames': ['Drug: EG017 ointment placebo']}], 'interventions': [{'name': 'EG017 ointment', 'type': 'DRUG', 'description': 'Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks', 'armGroupLabels': ['EG017 ointment 3%', 'EG017 ointment 5%', 'EG017 ointment 9%']}, {'name': 'EG017 ointment placebo', 'type': 'DRUG', 'description': 'Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks', 'armGroupLabels': ['Placebo A', 'Placebo B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '361016', 'city': 'Xiamen', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zuguo Liu, Doctor', 'role': 'CONTACT', 'email': 'zuguoliu@xmu.edu.cn', 'phone': '+86-13696984489'}], 'facility': 'Xiamen Ophthalmology Center Affiliated to Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}], 'centralContacts': [{'name': 'Wen Xu', 'role': 'CONTACT', 'email': 'xuwen01@gensci-china.com', 'phone': '+86 18861095711'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changchun GeneScience Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}