A Study for the Treatment of 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

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

Study Overview

• Status: Recruiting
• Conditions: Postmenopausal Women With DED
• Intervention / Treatment: Drug: EG017 ointment; Drug: EG017 ointment placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wen Xu; Phone Number: +86 18861095711; Email: xuwen01@gensci-china.com

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361016
      • Recruiting
      • Xiamen Ophthalmology Center Affiliated to Xiamen University
      • Contact: Zuguo Liu, Doctor; Phone Number: +86-13696984489; Email: zuguoliu@xmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): August 9, 2024

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: GenSci100-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No