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

NCT06221345 | Completed Phase 4

• 1 other identifier: 60298913
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease; Cataract

Keywords

Hyaluronic Acid; Hydroxypropyl guar; Carboxymethylcellulose

Outcome Measures

Primary Outcomes (1)

• Corneal fluorescein staining (CFS) score

  The CFS will be evaluated by external eye photography using the National Eye Institute (NEI) staining grid in which a score of 0 (normal) to 3 (severe) will be assigned to each of the 5 corneal regions (nasal, central, temporal, superior, and inferior). The CFS score will range between 0 and 15, and the maximum score of 15 indicates severe epitheliopathy.

  Change from baseline to Weeks 1 and 3

Secondary Outcomes (5)

• Ocular Surface Disease Index (OSDI)

  Change from baseline to Weeks 1 and 3

• Schirmer's test (without anesthesia)

  Change from baseline to Weeks 1 and 3

• Tear break-up time (TBUT)

  Change from baseline to Weeks 1 and 3

• Central corneal sensitivity

  Change from baseline to Weeks 1 and 3

• Slit-lamp examination

  Change from baseline to Weeks 1 and 3

Study Arms (2)

HPG/HA group

EXPERIMENTAL

Systane HYDRATION®

Drug: Systane HYDRATION® Preservative-Free Lubricant Eye Drops

CMC/HA group

ACTIVE COMPARATOR

Optive Fusion®

Drug: Optive Fusion® Lubricant Eye Drops (Unit Dose)

Interventions

Systane HYDRATION® Preservative-Free Lubricant Eye Drops 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

HPG/HA group

Optive Fusion® Lubricant Eye Drops (Unit Dose) 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

CMC/HA group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Before enrollment, corneal contact lens wear, history of severe systemic disease, or other conditions in the Investigator's opinion precluded enrollment.
• Patients will be withdrawn from the study if they experience complications during surgery, or post-surgical ocular hypertension, endophthalmitis, or infectious keratitis.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Keelung Chang Gung Memorial Hospital

Keelung, Taiwan

Location

Related Publications (1)

• Sun CC, Chan YH, Huang PW, Chen NN. Evaluation of Two Artificial Tears Containing Hyaluronic Acid for Post Cataract Surgery Dry Eye Disease: A Randomized Controlled Trial. Ophthalmol Ther. 2024 Oct;13(10):2615-2627. doi: 10.1007/s40123-024-01015-9. Epub 2024 Aug 10.

  PMID: 39127813 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes; Cataract

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Lens Diseases

Study Officials

• Chi-Chin Sun, M.D, Ph.D

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine Chang Gung University Taoyuan, Taiwan ; Doctor, Department of Ophthalmology, Chang Gung Memorial Hospital, Keelung, Taiwan

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 24, 2024
• Study Start: December 7, 2021
• Primary Completion: July 5, 2023
• Study Completion: July 5, 2023
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

TW (1)