Efficacy and Acceptability of Two Lubricant Eye Drops
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|ClinicalTrials.gov Identifier: NCT00756678|
Recruitment Status : Completed
First Posted : September 22, 2008
Results First Posted : October 31, 2011
Last Update Posted : October 31, 2011
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndromes||Drug: Lubricant Eye Drops (Optive™) Drug: Lubricating Eye Drops (blink® Tears)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Crossover Assignment|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
Active Comparator: 1
Carboxymethylcellulose and Glycerin
Drug: Lubricant Eye Drops (Optive™)
1 drop in both eyes as needed for 7 days`
Other Name: Optive™
Active Comparator: 2
Polyethylene glycol 400
Drug: Lubricating Eye Drops (blink® Tears)
1 drop in both eyes as needed for 7 days
Other Name: blink® Tears
- Mean Frequency of Eye Drop Use Over 1 Week [ Time Frame: 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.
- Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756678
|United States, Maryland|
|Chevy Chase, Maryland, United States|
|Study Director:||Medical Director||Allergan|