Efficacy and Acceptability of Two Lubricant Eye Drops

Dry Eye Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756678
• Other study ID #: MA-OPT-08-001
• Status: Completed
• Phase: Phase 4
• First received: September 18, 2008
• Last updated: September 22, 2011
• Start date: September 2008
• Est. completion date: August 2009

Study information

• Verified date: September 2011
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Lubricant Eye Drops (Optive™)
1 drop in both eyes as needed for 7 days`
• Lubricating Eye Drops (blink® Tears)
1 drop in both eyes as needed for 7 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No