Clinical trial NCT06221345: Hyaluronic Acid-containing Artificial Tears in Post-cataract Surgery Dry Eye Disease
Official title: Comparison of Different Hyaluronic Acid-containing Artificial Tears on the Ocular Surface Disease in Patients With Post-cataract Surgery Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Disease
Cataract
Keywords: Hyaluronic Acid
Hydroxypropyl guar
Carboxymethylcellulose
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) patients after cataract surgery.

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 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.

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.

Primary outcomes:
measure: Corneal fluorescein staining (CFS) score
timeFrame: Change from baseline to Weeks 1 and 3
Secondary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: Change from baseline to Weeks 1 and 3
measure: Schirmer's test (without anesthesia)
timeFrame: Change from baseline to Weeks 1 and 3
measure: Tear break-up time (TBUT)
timeFrame: Change from baseline to Weeks 1 and 3
measure: Central corneal sensitivity
timeFrame: Change from baseline to Weeks 1 and 3
measure: Slit-lamp examination
timeFrame: Change from baseline to Weeks 1 and 3
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Keelung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chi-Chin Sun, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: