Phase 3
Completed N=148
A Study to Compare the Safety and Efficacy of a New Eye Drop Formulation With REFRESH PLUS® in Participants Following LASIK Refractive Surgery
Bilateral LASIK Surgery
Source: ClinicalTrials.gov NCT01886690 ↗
Enrolled (actual)
148
Serious AEs
0.7%
Results posted
Oct 2015
Primary outcomePrimary: Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale — 6.99; 6.63 Scores on a Scale
Summary
This study will compare the safety and efficacy of a new eye drop formulation with REFRESH PLUS® in participants following LASIK surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale |
6.99; 6.63 | — |
| SECONDARY Change From Baseline in Corneal Staining in the Worse Eye |
0.9; 1.2; 0.2; -0.3 | — |
| SECONDARY Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye |
11.88; 9.27; 1.21; 1.08 | — |
| SECONDARY Change From Baseline in the Schirmer Test in the Worse Eye |
13.1; 13.0; 1.4; 1.3 | — |
| SECONDARY Change From Baseline in Uncorrected Visual Acuity in the Worse Eye |
51.1; 53.1; 5.8; 4.7 | — |
Eligibility Criteria
Inclusion Criteria
-Patients scheduled for LASIK surgery in both eyes.
Exclusion Criteria
- Any systemic medication use within 3 months of screening (including over the counter, herbal, prescription, or nutritional supplement) which may affect dry eye or vision
- Use of topical eye medication other than prescribed for use in pre- or post-operative care
- Use of RESTASIS® or other topical ophthalmic cyclosporine product within 6 months prior to Screening
- Eye infection, inflammation, or allergy
- Soft contact lenses in the previous 7 days or rigid contact lenses in the previous 30 days prior to LASIK surgery.
Data sourced from ClinicalTrials.gov (NCT01886690). 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.