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
Overview
- Phase
- Phase 2
- Intervention
- EG017 ointment
- Conditions
- Postmenopausal Women With DED
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- tCFS
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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
Detailed Description
To evaluate the efficacy and safety of EG017 ointment for the treatment of DED in postmenopausal women
Investigators
Eligibility 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;
Arms & Interventions
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
Intervention: EG017 ointment
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
Intervention: EG017 ointment
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
Intervention: EG017 ointment
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
Intervention: EG017 ointment placebo
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
Intervention: EG017 ointment placebo
Outcomes
Primary Outcomes
tCFS
Time Frame: 8 weeks
Change from baseline in tCFS（Total corneal fluorescein staining）after 8-week of treatment