Treatment for dry eye in postmenopausal women

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

This study is testing a new ointment for dry eye in postmenopausal women to see if it helps improve their symptoms better than a placebo.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Xiamen, Fujian)
• Trial ID: NCT06133166 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial evaluates the efficacy and safety of EG017 ointment for treating dry eye disease (DED) specifically in postmenopausal women. The study is multicenter, randomized, double-blind, and placebo-controlled, ensuring rigorous assessment of the treatment's effects. Participants will be monitored for their response to the ointment compared to a placebo over a defined period. The trial aims to provide insights into a new therapeutic option for a condition that significantly impacts quality of life.

Who should consider this trial

Good fit: Ideal candidates for this study are postmenopausal women aged 18 and older who have been diagnosed with dry eye disease for at least six months.

Not a fit: Patients with dry eye disease secondary to specific conditions like scar formation or those with a history of allergic reactions to the study drug will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for postmenopausal women suffering from dry eye disease.

How similar studies have performed: While this approach is being tested in this specific population, similar studies have shown promise in treating dry eye disease with various interventions.

Eligibility 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.

Where this trial is running

Xiamen, Fujian

• Xiamen Ophthalmology Center Affiliated to Xiamen University — Xiamen, Fujian, China (RECRUITING)

Study contacts

• Study coordinator: Wen Xu

Conditions: Postmenopausal Women With DED