Back to resultsSafety and Efficacy of an Artificial Tear for the Treatment of Dry Eye
Primary Purpose
Dry Eye Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carboxymethylcellulose and Glycerin based artificial tear
Carboxymethylcellulose
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Carboxymethylcellulose and Glycerin based artificial tear
Carboxymethylcellulose
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Change From Baseline at Day 30 in Schirmer Test, With Anesthesia
Schirmer Test measures the rate of the secretion of tears
Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein
Measures the stability of tear film. The average of 3 measures.
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).
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).
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)
Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein
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
Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00514852
Brief Title
Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
316 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Carboxymethylcellulose and Glycerin based artificial tear
Arm Title
2
Arm Type
Active Comparator
Arm Description
Carboxymethylcellulose
Intervention Type
Drug
Intervention Name(s)
Carboxymethylcellulose and Glycerin based artificial tear
Intervention Description
1 to 2 drops into each eye as needed but at least twice daily
Intervention Type
Drug
Intervention Name(s)
Carboxymethylcellulose
Other Intervention Name(s)
Refresh Plus
Intervention Description
1 to 2 drops into each eye as needed but at least twice daily
Primary Outcome Measure Information:
Title
Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score
Description
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 Outcome Measure Information:
Title
Change From Baseline at Day 30 in Schirmer Test, With Anesthesia
Description
Schirmer Test measures the rate of the secretion of tears
Time Frame
Change from baseline at Day 30
Title
Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein
Description
Measures the stability of tear film. The average of 3 measures.
Time Frame
Change from baseline at Day 30
Title
Patient Acceptability Score (Dryness) at Day 30
Description
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
Title
Patient Acceptability Score (Vision) at Day 30
Description
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
Title
Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein
Description
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
Title
Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein
Description
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)
Time Frame
Change from baseline at Day 30
Title
Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score
Description
Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe)
Time Frame
Change from baseline at Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
San Diego
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye
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