Efficacy and Acceptability of Two Lubricant Eye Drops

Study Overview
=================
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.

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: Lubricant Eye Drops (Optive™)
* Drug: Lubricating Eye Drops (blink® Tears)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Carboxymethylcellulose and Glycerin | Drug: Lubricant Eye Drops (Optive™)<br>* 1 drop in both eyes as needed for 7 days'<br>* Other names: Optive™;|
| Active Comparator: 2<br>Polyethylene glycol 400 | Drug: Lubricating Eye Drops (blink® Tears)<br>* 1 drop in both eyes as needed for 7 days<br>* Other names: blink® Tears;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Day 16 | 
| 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. | Day 16 | 
| 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. | Day 16 |