Hyaluronic Acid-containing Artificial Tears in Post-cataract Surgery Dry Eye Disease

Chang Gung Medical Foundation

Status and phase

Completed

Phase 4

Conditions

Cataract

Dry Eye Disease

Treatments

Drug: Systane HYDRATION® Preservative-Free Lubricant Eye Drops

Drug: Optive Fusion® Lubricant Eye Drops (Unit Dose)

Study type

Interventional

Funder types

Other

Identifiers

NCT06221345

60298913

Details and patient eligibility

About

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) patients after cataract surgery.

Full 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 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 groups will receive 1-2 drops of artificial tears 4 times daily for 3 weeks.

There are three visits scheduled in this study, i.e., screening, Week 1, and Week 3. The subjects will return to the study sites during these visits for efficacy and safety assessments.

Enrollment

70 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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:
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

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.