A Study for the Treatment of Dry Eye in Postmenopausal Women

Study Overview
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Brief Summary
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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

Detailed Description
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To evaluate the efficacy and safety of EG017 ointment for the treatment of DED in postmenopausal women

Official Title
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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

Conditions
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Postmenopausal Women With DED

Intervention / Treatment
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* Drug: EG017 ointment
* Drug: EG017 ointment placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EG017 ointment 3%<br>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<br>* Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks<br>|
| Experimental: EG017 ointment 5%<br>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<br>* Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks<br>|
| Experimental: EG017 ointment 9%<br>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<br>* Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks<br>|
| Placebo Comparator: Placebo A<br>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<br>* Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks<br>|
| Placebo Comparator: Placebo B<br>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<br>* Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tCFS | Change from baseline in tCFS（Total corneal fluorescein staining）after 8-week of treatment | 8 weeks |