Phase 3
Completed N=460
A Study to Compare the Safety and Efficacy of A New Eye Drop Formulation With OPTIVE™ in Subjects With Dry Eye Disease
Source: ClinicalTrials.gov NCT01664949 ↗Enrolled (actual)
460
Serious AEs
2.0%
Results posted
Jun 2015
Primary outcomePrimary: Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90 — 41.77; 40.92; -16.88; -15.97 score on a scale
Summary
This study will evaluate the safety and efficacy of a carboxymethylcellulose based eye drop formulation compared with carboxymethylcellulose based preservative-free lubricant eye drops (OPTIVE™) in subjects with dry eye disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90 |
41.77; 40.92; -16.88; -15.97 | — |
| SECONDARY Change From Baseline in Tear Break-up Time (TBUT) |
4.50; 4.44; 2.69; 2.24 | — |
| SECONDARY Change From Baseline in Corneal Staining |
1.5; 1.6; -0.7; -0.9 | — |
| SECONDARY Change From Baseline in Conjunctival Staining |
2.8; 3.0; -1.3; -1.4 | — |
| SECONDARY Change From Baseline in the Schirmer Test |
9.29; 8.10; 1.38; 1.53 | — |
Eligibility Criteria
Inclusion Criteria
- Have used artificial tears for dry eye
Exclusion Criteria
- Start date of over the counter, herbal, prescription or nutritional supplements that may affect dry eye or vision within 3 months prior to study start or an anticipated change in dosage during the study
- History of eye surgery or trauma in the 6 months prior to study start
- Current use or use within 2 weeks of study start, of topical eye medications.
Data sourced from ClinicalTrials.gov (NCT01664949). 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. Informational only — not medical advice.