Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye

Allergan0 sites316 target enrollmentOctober 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: 316
Primary Endpoint: Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

January 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Allergan

Eligibility Criteria

Inclusion Criteria

•Mild, moderate or Severe Symptoms of Dry Eye

Exclusion Criteria

•Uncontrolled systemic disease
•Use of systemic medications affecting dry eye
•Pregnancy or planning a pregnancy
•Contact lens wear

Arms & Interventions

1

Carboxymethylcellulose and Glycerin based artificial tear

Intervention: Carboxymethylcellulose and Glycerin based artificial tear

2

Carboxymethylcellulose

Intervention: Carboxymethylcellulose

Outcomes

Primary Outcomes

Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score

Time Frame: Change from baseline at Day 30

Ocular Surface Disease Index© Questionnaire Score is measured on 12 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity)

Secondary Outcomes

Change From Baseline at Day 30 in Schirmer Test, With Anesthesia(Change from baseline at Day 30)
Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein(Change from baseline at Day 30)
Patient Acceptability Score (Dryness) at Day 30(Day 30)
Patient Acceptability Score (Vision) at Day 30(Day 30)
Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein(Change from baseline at Day 30)
Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein(Change from baseline at Day 30)
Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score(Change from baseline at Day 30)