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Efficacy and Acceptability of Two Lubricant Eye Drops

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00756678
First received: September 18, 2008
Last updated: September 22, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention Phase
Dry Eye Syndromes
 Drug: Lubricant Eye Drops (Optive™)
Drug: Lubricating Eye Drops (blink® Tears)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Mean Frequency of Eye Drop Use Over 1 Week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16 [ Time Frame: Baseline, Day 16 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 51
Study Start Date: September 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756678

Locations
United States, Maryland
Chevy Chase, Maryland, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00756678     History of Changes
Other Study ID Numbers: MA-OPT-08-001
Study First Received: September 18, 2008
Results First Received: September 22, 2011
Last Updated: September 22, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Tetrahydrozoline
 Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013