Phase 3
N=315
Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease
Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT01459588 ↗Enrolled (actual)
315
Serious AEs
0.6%
Results posted
Mar 2013
Primary outcome: Primary: Change From Baseline in Ocular Surface Disease Index© Questionnaire Score — 41.48; 38.27; 40.28; 40.18 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Carboxymethylcellulose Based Eye Drop Formulation A (Drug); Carboxymethylcellulose Based Eye Drop Formulation B (Drug); Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Drug); Carboxymethylcellulose Based Lubricant Eye Drops (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Ocular Surface Disease Index© Questionnaire Score |
41.48; 38.27; 40.28; 40.18; -15.66; -9.78 | — |
| SECONDARY Change From Baseline in Tear Break-up Time |
4.92; 4.61; 4.94; 5.06; 1.36; 1.21 | — |
| SECONDARY Change From Baseline in Corneal Staining |
4.9; 5.0; 5.0; 4.7; -0.7; 0.1 | — |
| SECONDARY Change From Baseline in Conjunctival Staining |
6.7; 6.3; 6.1; 6.7; -0.6; 0.5 | — |
| SECONDARY Change From Baseline in Schirmer Test Results |
10.3; 8.4; 10.4; 10.1; 1.8; 2.4 | — |
Summary
This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.
Eligibility Criteria
Inclusion Criteria
- Dry eyes
- Current use of eye drops for dry eye at least twice daily, on average for at least 3 months
Exclusion Criteria
- Cataract, laser-assisted in situ keratomileusis (LASIK), or photorefractive keratectomy (PRK) surgery in the last 12 months
- Need to wear contact lenses during the study, or has worn contact lenses in the last 6 months
- Active ocular allergy
Data sourced from ClinicalTrials.gov (NCT01459588). 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.