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

Launched by CHANG GUNG MEMORIAL HOSPITAL · Jan 13, 2024

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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...

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 Patients will be withdrawn from the study if they experience complications during surgery, or post-surgical ocular hypertension, endophthalmitis, or infectious keratitis.