Efficacy and Acceptability of Two Lubricant Eye Drops

September 22, 2011 updated by: Allergan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Carboxymethylcellulose and Glycerin
Drug: Lubricant Eye Drops (Optive™)
1 drop in both eyes as needed for 7 days'
Other Names:
  • Optive™
Active Comparator: 2
Polyethylene glycol 400
Drug: Lubricating Eye Drops (blink® Tears)
1 drop in both eyes as needed for 7 days
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
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.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Day 16
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".
Day 16
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.
Day 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

September 18, 2008

First Submitted That Met QC Criteria

September 19, 2008

First Posted (Estimate)

September 22, 2008

Study Record Updates

Last Update Posted (Estimate)

October 31, 2011

Last Update Submitted That Met QC Criteria

September 22, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-OPT-08-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe