Hyaluronic Acid-containing Artificial Tears in Post-cataract Surgery Dry Eye Disease
Launched by CHANG GUNG MEMORIAL HOSPITAL · Jan 13, 2024
Trial Information
Current as of May 19, 2025
Completed
Keywords
ClinConnect Summary
This is a prospective, open-label, assessor-masked, interventional, randomized controlled study. A total of 70 post-cataract surgery dry-eye subjects are planned to be enrolled after eligibility confirmation at Week 1 post-operative (post-op). The subjects will then be randomized in a 1:1 ratio to either HPG/HA (Systane HYDRATION® ) or CMC/HA (Optive Fusion®) group.
From Week 1 to 3 (1st to 4th week post-op), the HPG/HA group will receive Systane HYDRATION® Preservative-Free Lubricant Eye Drops whereas the CMC/HA group will receive Optive Fusion® Lubricant Eye Drops (Unit Dose). Both group...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Male or female patients of any race, 20 years or older who are scheduled for unilateral cataract surgery.
- 2. DED patients whose symptoms and signs are aggravated at baseline assessment after cataract surgery will be eligible for this study. Postoperative dry eye diagnosis criteria at baseline assessment:
- • 1. OSDI score \>14.8\* (\*Eligible subject mandatory required);
- • 2. positive CFS\* (\*Eligible subject mandatory required);
- • 3. Schirmer's test score ≤10 mm in 5 minutes (min) (without anesthesia);
- • 4. TBUT ≤5 seconds (sec)
- Exclusion Criteria:
- • 1. Patients with allergy to any of the study medications, conjunctival allergy or infectious disease, history of ocular chemical or thermal burn, Stevens-Johnson syndrome or ocular pemphigoid, glaucoma or ocular hypertension, eyelid or lacrimal disease, any ocular operation within 3 months, graft-versus-host disease (GVHD), non-dry-eye ocular inflammation, trauma, or presence of uncontrolled systemic disease.
- • 2. Before enrollment, corneal contact lens wear, history of severe systemic disease, or other conditions in the Investigator's opinion precluded enrollment.
- • 3. Patients will be withdrawn from the study if they experience complications during surgery, or post-surgical ocular hypertension, endophthalmitis, or infectious keratitis.
About Chang Gung Memorial Hospital
Chang Gung Memorial Hospital, one of the largest healthcare organizations in Taiwan, is renowned for its commitment to advancing medical research and improving patient care. As a clinical trial sponsor, the hospital leverages its extensive clinical expertise and state-of-the-art facilities to conduct innovative research across various medical disciplines. With a focus on collaboration and ethical practices, Chang Gung Memorial Hospital aims to contribute to the global body of medical knowledge through rigorous clinical trials that enhance treatment options and improve health outcomes for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Keelung, , Taiwan
Patients applied
Trial Officials
Chi-Chin Sun, M.D, Ph.D
Principal Investigator
Chang Gung Memorial Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported