A Study for the Treatment of Dry Eye in Postmenopausal Women

NCT ID: NCT06133166

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-20
• Study Completion Date: 2024-08-09

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

Conditions

Postmenopausal Women With DED

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

EG017 ointment

Intervention Type: DRUG

Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks

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

Group Type: EXPERIMENTAL

EG017 ointment

Intervention Type: DRUG

Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks

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

Group Type: EXPERIMENTAL

EG017 ointment

Intervention Type: DRUG

Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks

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

Group Type: PLACEBO_COMPARATOR

EG017 ointment placebo

Intervention Type: DRUG

Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks

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

Group Type: PLACEBO_COMPARATOR

EG017 ointment placebo

Intervention Type: DRUG

Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks

Interventions

EG017 ointment

Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks

Intervention Type: 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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xiamen Ophthalmology Center Affiliated to Xiamen University

Xiamen, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wen Xu

Role: CONTACT

xuwen01@gensci-china.com

+86 18861095711

Facility Contacts

Zuguo Liu, Doctor

Role: primary

zuguoliu@xmu.edu.cn

+86-13696984489

Other Identifiers

GenSci100-202

Identifier Type: -

Identifier Source: org_study_id