Efficacy and Acceptability of Two Lubricant Eye Drops

Phase 4

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: Lubricant Eye Drops (Optive™); Drug: Lubricating Eye Drops (blink® Tears)

• Registration Number: NCT00756678
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-18
• Study First Submitted QC: 2008-09-19
• Study First Posted: 2008-09-22
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2011-09
• Results First Submitted: 2011-09-22
• Results First Submitted QC: 2011-09-22
• Last Update Submitted: 2011-09-22
• Results First Posted: 2011-10-31
• Last Update Posted: 2011-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Lubricant Eye Drops (Optive™)	Carboxymethylcellulose and Glycerin
2	Lubricating Eye Drops (blink® Tears)	Polyethylene glycol 400

Primary Outcome Measures

Name	Time	Method
Mean Frequency of Eye Drop Use Over 1 Week	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

Name	Time	Method
Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16	Baseline, 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	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	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.