Status:
COMPLETED
Hyaluronic Acid-containing Artificial Tears in Post-cataract Surgery Dry Eye Disease
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Dry Eye Disease
Cataract
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
To compare the effects of hydroxypropyl guar (HPG)/hyaluronic acid (HA)- and carboxymethylcellulose (CMC)/HA-based lubricant eye drops on subjective and objective outcomes in dry eye disease (DED) pat...
Detailed Description
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 confi...
Eligibility Criteria
Inclusion
- Male or female patients of any race, 20 years or older who are scheduled for unilateral cataract surgery.
- 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:
- 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
- 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.
- Before enrollment, corneal contact lens wear, history of severe systemic disease, or other conditions in the Investigator's opinion precluded enrollment.
- Patients will be withdrawn from the study if they experience complications during surgery, or post-surgical ocular hypertension, endophthalmitis, or infectious keratitis.
Key Trial Info
Start Date :
December 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06221345
Start Date
December 7 2021
End Date
July 5 2023
Last Update
January 24 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Keelung Chang Gung Memorial Hospital
Keelung, Taiwan