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

Not Applicable

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: Carboxymethylcellulose and Glycerin based artificial tear; Drug: Carboxymethylcellulose

• Registration Number: NCT00514852
• Lead Sponsor: Allergan

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-08
• Study First Submitted QC: 2007-08-08
• Study First Posted: 2007-08-10
• Study Start: 2007-10
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2009-05-19
• Status Verified: 2009-11
• Results First Submitted QC: 2009-11-10
• Last Update Submitted: 2009-11-10
• Results First Posted: 2009-12-15
• Last Update Posted: 2009-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 316

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Carboxymethylcellulose and Glycerin based artificial tear	Carboxymethylcellulose and Glycerin based artificial tear
2	Carboxymethylcellulose	Carboxymethylcellulose

Primary Outcome Measures

Name	Time	Method
Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score	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 Outcome Measures

Name	Time	Method
Change From Baseline at Day 30 in Schirmer Test, With Anesthesia	Change from baseline at Day 30	Schirmer Test measures the rate of the secretion of tears
Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein	Change from baseline at Day 30	Measures the stability of tear film. The average of 3 measures.
Patient Acceptability Score (Dryness) at Day 30	Day 30	Dryness Severity Visual Analog Scale is measured on a 0-100 point scale (0 = could not be worse, 100 = none at all).
Patient Acceptability Score (Vision) at Day 30	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).
Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein	Change from baseline at Day 30	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)
Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein	Change from baseline at Day 30	Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-30 (0=no staining, 30=most severe staining)
Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score	Change from baseline at Day 30	Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe)