Last updated: January 13, 2024
Sponsor: Chang Gung Memorial Hospital
Overall Status: Completed
Phase
4
Condition
Eye Disease
Vision Loss
Eye Disorders/infections
Treatment
Optive Fusion® Lubricant Eye Drops (Unit Dose)
Systane HYDRATION® Preservative-Free Lubricant Eye Drops
Clinical Study ID
NCT06221345
60298913
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female patients of any race, 20 years or older who are scheduled forunilateral cataract surgery.
- DED patients whose symptoms and signs are aggravated at baseline assessment aftercataract surgery will be eligible for this study. Postoperative dry eye diagnosiscriteria at baseline assessment:
- OSDI score >14.8* (*Eligible subject mandatory required);
- positive CFS* (*Eligible subject mandatory required);
- Schirmer's test score ≤10 mm in 5 minutes (min) (without anesthesia);
- TBUT ≤5 seconds (sec)
Exclusion
Exclusion Criteria:
- Patients with allergy to any of the study medications, conjunctival allergy orinfectious disease, history of ocular chemical or thermal burn, Stevens-Johnsonsyndrome or ocular pemphigoid, glaucoma or ocular hypertension, eyelid or lacrimaldisease, any ocular operation within 3 months, graft-versus-host disease (GVHD),non-dry-eye ocular inflammation, trauma, or presence of uncontrolled systemic disease.
- Before enrollment, corneal contact lens wear, history of severe systemic disease, orother conditions in the Investigator's opinion precluded enrollment.
- Patients will be withdrawn from the study if they experience complications duringsurgery, or post-surgical ocular hypertension, endophthalmitis, or infectiouskeratitis.
Study Design
Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Optive Fusion® Lubricant Eye Drops (Unit Dose)
Phase: 4
Study Start date:
December 07, 2021
Estimated Completion Date:
July 05, 2023
Study Description
Connect with a study center
Keelung Chang Gung Memorial Hospital
Keelung,
TaiwanSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.