Phase 4
N=51
Efficacy and Acceptability of Two Lubricant Eye Drops
Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT00756678 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcome: Primary: Mean Frequency of Eye Drop Use Over 1 Week — 1.76; 1.66 Use per day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lubricant Eye Drops (Optive™) (Drug); Lubricating Eye Drops (blink® Tears) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Frequency of Eye Drop Use Over 1 Week |
1.76; 1.66 | — |
| SECONDARY Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16 |
4.65; 4.62; -1.41; -1.47 | — |
| SECONDARY Percentage of Positive Patient Responses to Subject Acceptability Questionnaire on Day 16 |
86; 78 | — |
| SECONDARY Number of Patients With Positive Responses to Subject Preference Questionnaire on Day 16 |
16; 22 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00756678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.