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Efficacy and Acceptability of Two Lubricant Eye Drops

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00756678
Recruitment Status : Completed
First Posted : September 22, 2008
Results First Posted : October 31, 2011
Last Update Posted : October 31, 2011
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: Lubricant Eye Drops (Optive™) Drug: Lubricating Eye Drops (blink® Tears) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : September 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

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 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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".

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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United States, Maryland
Chevy Chase, Maryland, United States
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00756678    
Other Study ID Numbers: MA-OPT-08-001
First Posted: September 22, 2008    Key Record Dates
Results First Posted: October 31, 2011
Last Update Posted: October 31, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
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Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions