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OpenTrials
Completed

NCT Number: NCT00756678

Efficacy and Acceptability of Two Lubricant Eye Drops

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.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chevy Chase, Maryland, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lubricant Eye Drops (Optive™)

Drug

1 drop in both eyes as needed for 7 days'

Other names: Optive™

Lubricating Eye Drops (blink® Tears)

Drug

1 drop in both eyes as needed for 7 days

Other names: blink® Tears

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 22, 2008
Registry last updated
Oct 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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