Effectiveness and Safety of CG-101 Eye Drops in the Treatment of Dry Eye Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

This study is a single-center, randomized, double-blind, placebo-controlled, cross-over clinical trial designed to evaluate the effectiveness and safety of CG-101 eye drops for the treatment of dry eye syndrome, using a placebo as a control.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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‣ Patients must meet all the following inclusion criteria to be enrolled in this study:

• Age ≥ 18 years, regardless of gender;

• Clearly understand and voluntarily participate in the study, with the ability and willingness to sign a written informed consent form (ICF) and comply with all study assessments and visits as instructed;

• Male and female participants of childbearing potential must agree to use medically acceptable contraception during the study and for 3 months (90 days) after the study ends. Women who are not postmenopausal or have not been menopausal for less than two years (from the last menstrual period to the signing of the ICF) must have a negative pregnancy test at Visits 0 and 1.

• A history of bilateral dry eye disease prior to the screening visit (i.e., at least one of the following subjective symptoms: ocular dryness, foreign body sensation, burning sensation, fatigue, discomfort, redness, or fluctuating vision);

• Recent use (within 30 days prior to Visit 0) of artificial tears to relieve dry eye symptoms, with discontinuation of artificial tears at least 72 hours before Visit 0;

• Ocular Surface Disease Index (OSDI) total score ≥ 13 at Visit 0;

• Best corrected visual acuity ≥ 4.3 (5-point recording method on the international standard logarithmic visual acuity chart at 5 meters) in both eyes at Visit 0;

• At least one eye must have a positive corneal fluorescein staining score (CFS) at Visits 0 and 1;

• Non-anesthetic tear secretion test (SIT) ≤ 10 mm/5 min at Visits 0 and 1;

⁃ Tear film break-up time (BUT) ≤ 10 seconds at Visits 0 and 1.

Locations
Other Locations
China
Eye & ENT hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Jiaxu Hong, M.D., Ph.D,
yokchingwu@163.com
021-64377134
Time Frame
Start Date: 2024-04-23
Estimated Completion Date: 2025-05-22
Participants
Target number of participants: 30
Treatments
Experimental: CG101 high dose
Patient in this group received high dose CG101 eyedrops in period 1 (0W to 4W) and received placebo in period 2 (8W to 12W).
Experimental: CG101 low dose
Patient in this group received low dose CG101 eyedrops in period 1 ( 0W to 4W) and received high dose CG101 eyedrops in period 2 ( 8W to 12W).
Placebo_comparator: Placebo
Patient in this group received placebo eyedrops in period 1 (0W to 4W) and received low dose CG101 eyedrops in period 2 (8W to 12W).
Related Therapeutic Areas
Sponsors
Leads: Eye & ENT Hospital of Fudan University

This content was sourced from clinicaltrials.gov