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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-07

Study Completion Date

2023-07-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dry Eye Disease Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HPG/HA group

Systane HYDRATION®

Group Type EXPERIMENTAL

Systane HYDRATION® Preservative-Free Lubricant Eye Drops

Intervention Type DRUG

The HPG/HA group will receive Systane HYDRATION® Preservative-Free Lubricant Eye Drops and standard of care, i.e., prednisolone acetate (Pred forte®) and levofloxacin (Cravit®), at the dosage of 1-2 drops 4 times daily for 3 weeks from Weeks 1 to 4 post-op

CMC/HA group

Optive Fusion®

Group Type ACTIVE_COMPARATOR

Optive Fusion® Lubricant Eye Drops (Unit Dose)

Intervention Type DRUG

The CMC/HA group will receive Optive Fusion® Lubricant Eye Drops (Unit Dose) and standard of care, i.e., prednisolone acetate (Pred forte®) and levofloxacin (Cravit®), at the dosage of 1-2 drops 4 times daily for 3 weeks from Weeks 1 to 4 post-op

Interventions

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Systane HYDRATION® Preservative-Free Lubricant Eye Drops

The HPG/HA group will receive Systane HYDRATION® Preservative-Free Lubricant Eye Drops and standard of care, i.e., prednisolone acetate (Pred forte®) and levofloxacin (Cravit®), at the dosage of 1-2 drops 4 times daily for 3 weeks from Weeks 1 to 4 post-op

Intervention Type DRUG

Optive Fusion® Lubricant Eye Drops (Unit Dose)

The CMC/HA group will receive Optive Fusion® Lubricant Eye Drops (Unit Dose) and standard of care, i.e., prednisolone acetate (Pred forte®) and levofloxacin (Cravit®), at the dosage of 1-2 drops 4 times daily for 3 weeks from Weeks 1 to 4 post-op

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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CHI-CHIN-SUN

Professor, School of Medicine Chang Gung University Taoyuan, Taiwan ; Doctor, Department of Ophthalmology, Chang Gung Memorial Hospital, Keelung, Taiwan

Responsibility Role PRINCIPAL_INVESTIGATOR