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Search / Trial NCT06221345

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

Hyaluronic Acid Hydroxypropyl Guar Carboxymethylcellulose

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 Patients will be withdrawn from the study if they experience complications during surgery, or post-surgical ocular hypertension, endophthalmitis, or infectious keratitis.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.

Locations

Keelung, , Taiwan

Patients applied

0 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