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

November 10, 2009 updated by: Allergan
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

316

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Carboxymethylcellulose and Glycerin based artificial tear
Drug: Carboxymethylcellulose and Glycerin based artificial tear
1 to 2 drops into each eye as needed but at least twice daily
Active Comparator: 2
Carboxymethylcellulose
Drug: Carboxymethylcellulose
1 to 2 drops into each eye as needed but at least twice daily
Other Names:
  • Refresh Plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline at Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline at Day 30 in Schirmer Test, With Anesthesia
Time Frame: Change from baseline at Day 30
Schirmer Test measures the rate of the secretion of tears
Change from baseline at Day 30
Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein
Time Frame: Change from baseline at Day 30
Measures the stability of tear film. The average of 3 measures.
Change from baseline at Day 30
Patient Acceptability Score (Dryness) at Day 30
Time Frame: Day 30
Dryness Severity Visual Analog Scale is measured on a 0-100 point scale (0 = could not be worse, 100 = none at all).
Day 30
Patient Acceptability Score (Vision) at Day 30
Time Frame: 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).
Day 30
Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein
Time Frame: 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
Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein
Time Frame: 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
Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score
Time Frame: Change from baseline at Day 30
Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe)
Change from baseline at Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

August 8, 2007

First Submitted That Met QC Criteria

August 8, 2007

First Posted (Estimate)

August 10, 2007

Study Record Updates

Last Update Posted (Estimate)

December 15, 2009

Last Update Submitted That Met QC Criteria

November 10, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG9818-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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