N/A
N=228
Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery
Dry Eye Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00544713 ↗Enrolled (actual)
228
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90 — 8.32; 6.43 Scores on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Carboxymethylcellulose and Glycerin based artificial tear (Drug); Carboxymethylcellulose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90 |
8.32; 6.43 | — |
| SECONDARY Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 |
88.4; 93.6; 94.6; 94.5; 95.5; 95.4 | — |
| SECONDARY Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 |
79.5; 87.2; 64.3; 82.4; 66.1; 80.6 | — |
| SECONDARY Best Corrected Visual Acuity (BCVA) Status at Day 90 |
8; 7; 104; 107; 1; 0 | — |
| SECONDARY Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90 |
31.95; 32.32; -2.12; -2.24 | — |
| SECONDARY Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90 |
1.32; 1.25; -0.49; -0.26 | — |
| SECONDARY Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90 |
0.521; 0.520; -0.058; -0.047 | — |
| SECONDARY Change From Baseline of the Worse Eye in Schirmer's Test at Day 90 |
16.3; 13.5; -0.3; 1.7 | — |
| SECONDARY Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90 |
0.5; 0.5; 0.0; 0.0 | — |
| SECONDARY Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90 |
1.0; 0.8; 0.0; -0.3 | — |
| SECONDARY Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90 |
13.66; 13.25; -0.92; -0.87 | — |
| SECONDARY Change From Baseline in Study Product Usage at Day 90 |
7.9; 7.9; -4.9; -4.5 | — |
Summary
This study will evaluate the safety and efficacy of a new artificial tear for the treatment of dry eye that may occur after LASIK surgery
Eligibility Criteria
Inclusion Criteria
- Candidate for bilateral LASIK surgery for myopia correction in the range of -1.00 to -8.00 diopters
Exclusion Criteria
- Dry eye signs and symptoms
- Preoperative soft or rigid contact lens wear within last 7 or 30 days, respectively
- Pregnancy or planning pregnancy
- Uncontrolled systemic disease
- Use of systemic medications affecting dry eye
Data sourced from ClinicalTrials.gov (NCT00544713). 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.