Back to resultsEfficacy and Acceptability of Two Lubricant Eye Drops
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lubricant Eye Drops (Optive™)
Lubricating Eye Drops (blink® Tears)
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
Eligibility Criteria
Inclusion Criteria:
- Male or Female
- At least 18 years of age
- Current use of artificial tears
Exclusion Criteria:
- Any uncontrolled systemic disease
- Pregnancy or planning a pregnancy
- Contact lens wear
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Carboxymethylcellulose and Glycerin
Polyethylene glycol 400
Outcomes
Primary Outcome Measures
Mean Frequency of Eye Drop Use Over 1 Week
Mean frequency of eye drop use per day per patient during the cross-over period over 1 week. Eye drop use was captured on a daily tear diary that the patients completed. The greater the frequency of use, the more eye drops were required to manage the patient's dry eye symptoms.
Secondary Outcome Measures
Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16
Mean change from baseline in Dry Eye Disease Comfort Assessment Score at Day 16. The Dry Eye Disease Comfort Assessment consists of one question asking the patient to rate their current overall discomfort from their dry eye symptoms on a scale of 0 to 10 (0 equals No Discomfort; 10 equals Intolerable). The greater the negative number change from baseline, the greater the improvement in comfort.
Percentage of Positive Patient Responses to Subject Acceptability Questionnaire on Day 16
Percentage of patients who responded "Strongly Agree" and "Agree" to Subject Acceptability Questionnaire Question 1: Overall Liked. The Subject Acceptability Questionnaire consists of 11 multiple choice questions assessing how the patients feel about the eye drops received. The 5 possible responses to the questionnaire are "Strongly Agree", "Agree", "Neither Agree or Disagree", "Disagree" and "Strongly Disagree".
Number of Patients With Positive Responses to Subject Preference Questionnaire on Day 16
Number of patients who marked that either Week 1 study product was more soothing or Week 2 study product was more soothing to the Overall Comfort Preference Questionnaire on Day 16 of the cross-over period. The Subject Preference Questionnaire consists of 4 questions related to comfort, soothing, blurring and purchase preference comparing treatments received during Week 1 versus Week 2.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00756678
Brief Title
Efficacy and Acceptability of Two Lubricant Eye Drops
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Efficacy and acceptability of two new artificial tears following two weeks of treatment in patients with dry eye. Patients will be randomized to 1 of 2 treatments for 7 days then crossover to the alternate treatment for 7 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Carboxymethylcellulose and Glycerin
Arm Title
2
Arm Type
Active Comparator
Arm Description
Polyethylene glycol 400
Intervention Type
Drug
Intervention Name(s)
Lubricant Eye Drops (Optive™)
Other Intervention Name(s)
Optive™
Intervention Description
1 drop in both eyes as needed for 7 days'
Intervention Type
Drug
Intervention Name(s)
Lubricating Eye Drops (blink® Tears)
Other Intervention Name(s)
blink® Tears
Intervention Description
1 drop in both eyes as needed for 7 days
Primary Outcome Measure Information:
Title
Mean Frequency of Eye Drop Use Over 1 Week
Description
Mean frequency of eye drop use per day per patient during the cross-over period over 1 week. Eye drop use was captured on a daily tear diary that the patients completed. The greater the frequency of use, the more eye drops were required to manage the patient's dry eye symptoms.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16
Description
Mean change from baseline in Dry Eye Disease Comfort Assessment Score at Day 16. The Dry Eye Disease Comfort Assessment consists of one question asking the patient to rate their current overall discomfort from their dry eye symptoms on a scale of 0 to 10 (0 equals No Discomfort; 10 equals Intolerable). The greater the negative number change from baseline, the greater the improvement in comfort.
Time Frame
Baseline, Day 16
Title
Percentage of Positive Patient Responses to Subject Acceptability Questionnaire on Day 16
Description
Percentage of patients who responded "Strongly Agree" and "Agree" to Subject Acceptability Questionnaire Question 1: Overall Liked. The Subject Acceptability Questionnaire consists of 11 multiple choice questions assessing how the patients feel about the eye drops received. The 5 possible responses to the questionnaire are "Strongly Agree", "Agree", "Neither Agree or Disagree", "Disagree" and "Strongly Disagree".
Time Frame
Day 16
Title
Number of Patients With Positive Responses to Subject Preference Questionnaire on Day 16
Description
Number of patients who marked that either Week 1 study product was more soothing or Week 2 study product was more soothing to the Overall Comfort Preference Questionnaire on Day 16 of the cross-over period. The Subject Preference Questionnaire consists of 4 questions related to comfort, soothing, blurring and purchase preference comparing treatments received during Week 1 versus Week 2.
Time Frame
Day 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or Female
At least 18 years of age
Current use of artificial tears
Exclusion Criteria:
Any uncontrolled systemic disease
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
Chevy Chase
State/Province
Maryland
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Acceptability of Two Lubricant Eye Drops
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