A Study for the Treatment of Dry Eye in Postmenopausal Women

• Status: Recruiting
• Trial end date: 2024-08-09
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

1. Age ≥ 18 years old；

2. Postmenopausal women

3. Diagnosed with DED for at least 6 months;

4. 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:

1. Presence of a history of allergic reactions to the study drug, similar drugs or ingredients;

2. 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);

3. Screening slit lamp examinations reveal clinically significant ocular disease or abnormalities in the ocular anatomy

4. Schirmer test (without anesthesia) < 3mm/5min；

5. Screening stage CFS revealed a lamellar defect in the corneal epithelium or ≥ 2 areas of corneal staining fusion > 50%;

6. BCVA ≤ 0.2 in both eyes during the screening period;

7. 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;

8. 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;

9. History of treatment with topical steroids, topical NSAIDs, topical cyclosporine, lifitegrast, tacrolimus, serum tears, or topical antiglaucoma medications within 1 month prior to screening;

10. 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;

11. 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;

12. History of intraocular surgery or ocular laser surgery within 6 months prior to screening, or planned ocular or eyelid surgery during the study period;

13. Presence of a history of herpetic keratitis, ocular or periocular malignancy;

14. Presence of an infection requiring systemic antibiotic (including antibacterial, antiviral, antifungal) control within 7 days prior to screening;

15. Severe systemic autoimmune diseases;

16. Presence of the clinically significant diseases；

17. Participated in other drug or device clinical trials within 1 month prior to screening;

18. Any medical or other condition that the investigator believes may affect the clinical trial.