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

Allergan316 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

316

Conditions

Dry Eye Syndrome

Interventions

Carboxymethylcellulose and Glycerin based artificial tearDRUG

1 to 2 drops into each eye as needed but at least twice daily

CarboxymethylcelluloseDRUG

1 to 2 drops into each eye as needed but at least twice daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

San Diego, California, United States

Outcomes

Primary Outcomes

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

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)

Time frame: Change from baseline at Day 30

Secondary Outcomes

Change From Baseline at Day 30 in Schirmer Test, With Anesthesia

Schirmer Test measures the rate of the secretion of tears

Time frame: Change from baseline at Day 30

Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein

Measures the stability of tear film. The average of 3 measures.

Time frame: Change from baseline at Day 30

Patient Acceptability Score (Dryness) at Day 30

Dryness Severity Visual Analog Scale is measured on a 0-100 point scale (0 = could not be worse, 100 = none at all).

Time frame: Day 30

Patient Acceptability Score (Vision) at Day 30

Vision Quality Visual Analog Scale is measured on a 0-100 point scale (0 = very poor, has never been worse, 100 = excellent, has never been better).

Time frame: Day 30

Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein

Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-25 (0= no staining, 25 = most severe staining)

Time frame: Change from baseline at Day 30

Data from ClinicalTrials.gov

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