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

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

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female patients of any race, 20 years or older who are scheduled forunilateral cataract surgery.
  2. 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:
  3. OSDI score >14.8* (*Eligible subject mandatory required);
  4. positive CFS* (*Eligible subject mandatory required);
  5. Schirmer's test score ≤10 mm in 5 minutes (min) (without anesthesia);
  6. TBUT ≤5 seconds (sec)

Exclusion

Exclusion Criteria:

  1. 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.
  2. Before enrollment, corneal contact lens wear, history of severe systemic disease, orother conditions in the Investigator's opinion precluded enrollment.
  3. Patients will be withdrawn from the study if they experience complications duringsurgery, or post-surgical ocular hypertension, endophthalmitis, or infectiouskeratitis.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

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.

Connect with a study center

  • Keelung Chang Gung Memorial Hospital

    Keelung,
    Taiwan

    Site Not Available

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