Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery

Allergan0 sites228 target enrollmentSeptember 2007

ConditionsDry Eye Syndrome

InterventionsCarboxymethylcellulose and Glycerin based artificial tear Carboxymethylcellulose

DrugsCarboxymethylcellulose and Glycerin based artificial tear Carboxymethylcellulose

Overview

Phase: Not Applicable
Intervention: Carboxymethylcellulose and Glycerin based artificial tear
Conditions: Dry Eye Syndrome
Sponsor: Allergan
Enrollment: 228
Primary Endpoint: Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study will evaluate the safety and efficacy of a new artificial tear for the treatment of dry eye that may occur after LASIK surgery

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

June 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Candidate for bilateral LASIK surgery for myopia correction in the range of -1.00 to -8.00 diopters

Exclusion Criteria

•Dry eye signs and symptoms
•Preoperative soft or rigid contact lens wear within last 7 or 30 days, respectively
•Pregnancy or planning pregnancy
•Uncontrolled systemic disease
•Use of systemic medications affecting dry eye

Arms & Interventions

Carboxymethylcellulose and Glycerin based artificial tear

Intervention: Carboxymethylcellulose and Glycerin based artificial tear

Carboxymethylcellulose based artificial tear

Intervention: Carboxymethylcellulose

Outcomes

Primary Outcomes

Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90

Time Frame: Day 90

Measured on 12 domains (categories); a 5-point scale for each domain (0 = best, no dry eye symptoms, 4 = worst, constant dry eye symptoms). Sum of the domain scores is normalized (standardized) to a severity scale of 0-100 (0 = no symptoms (best score), 100 = maximum severity (worst score)).

Secondary Outcomes

Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90(Day 90)
Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90(Day 90)
Best Corrected Visual Acuity (BCVA) Status at Day 90(Day 90)
Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90(Baseline, Day 90)
Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90(Baseline, Day 90)
Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90(Baseline, Day 90)
Change From Baseline of the Worse Eye in Schirmer's Test at Day 90(Baseline, Day 90)
Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90(Baseline, Day 90)
Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90(Baseline, Day 90)
Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90(Baseline, Day 90)
Change From Baseline in Study Product Usage at Day 90(Baseline, Day 90)