A Study for the Treatment of Dry Eye in Postmenopausal Women
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
To evaluate the efficacy and safety of EG017 ointment for the treatment of DED in postmenopausal women
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EG017 ointment 3% 60 subjects，Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks |
Drug: EG017 ointment
Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks
|
| Experimental: EG017 ointment 5% 60 subjects，Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks |
Drug: EG017 ointment
Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks
|
| Experimental: EG017 ointment 9% 60 subjects，Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks |
Drug: EG017 ointment
Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks
|
| Placebo Comparator: Placebo A 40 subjects，Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks |
Drug: EG017 ointment placebo
Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks
|
| Placebo Comparator: Placebo B 20 subjects，Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks |
Drug: EG017 ointment placebo
Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks
|
Outcome Measures
Primary Outcome Measures
- tCFS [8 weeks]
Change from baseline in tCFS（Total corneal fluorescein staining）after 8-week of treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 18 years old；
-
Postmenopausal women
-
Diagnosed with DED for at least 6 months;
-
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;
6） Voluntarily participate in the trial, understand and sign written informed consent, and be willing and able to comply with the clinical trial arrangements
Exclusion Criteria:
-
Presence of a history of allergic reactions to the study drug, similar drugs or ingredients;
-
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);
-
Screening slit lamp examinations reveal clinically significant ocular disease or abnormalities in the ocular anatomy
-
Schirmer test (without anesthesia) < 3mm/5min；
-
Screening stage CFS revealed a lamellar defect in the corneal epithelium or ≥ 2 areas of corneal staining fusion > 50%;
-
BCVA ≤ 0.2 in both eyes during the screening period;
-
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;
-
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;
-
History of treatment with topical steroids, topical NSAIDs, topical cyclosporine, lifitegrast, tacrolimus, serum tears, or topical antiglaucoma medications within 1 month prior to screening;
-
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;
-
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;
-
History of intraocular surgery or ocular laser surgery within 6 months prior to screening, or planned ocular or eyelid surgery during the study period;
-
Presence of a history of herpetic keratitis, ocular or periocular malignancy;
-
Presence of an infection requiring systemic antibiotic (including antibacterial, antiviral, antifungal) control within 7 days prior to screening;
-
Severe systemic autoimmune diseases;
-
Presence of the clinically significant diseases；
-
Participated in other drug or device clinical trials within 1 month prior to screening;
-
Any medical or other condition that the investigator believes may affect the clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xiamen Ophthalmology Center Affiliated to Xiamen University | Xiamen | Fujian | China | 361016 |
Sponsors and Collaborators
- Changchun GeneScience Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GenSci100-202