Photorefractive Keratectomy
Conditions
Keywords
Photorefractive Keratectomy
Brief summary
The purpose of this study is to compare healing times and subjective pain level responses of nepafenac to placebo after photo refractive keratomileusis (PRK) surgery.
Interventions
DRUGnepafenac 0.1%
Nepafenac 0.1% randomly assigned to one eye, with ketorolac 0.4% in the fellow eye for contralateral post-surgical use.
OTHERketorolac 0.4%
Keterolac 0.4% randomly assigned to one eye, with nepafenac 0.1% in the fellow eye for contralateral post-surgical use.
Sponsors
Matthew Caldwell
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 19 years or older with healthy ocular status and pre-operative refractive anisometropia of less than 2.000 diopters between eyes undergoing bilateral PRK surgery. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Those desiring PRK in only one eye, those in need of additional topical eye medications, those with history of drug/alcohol abuse, women breastfeeding or pregnant. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective pain | Day 5 |
Secondary
| Measure | Time frame |
|---|---|
| Rate of epithelial healing | Time to event |
Countries
United States
Outcome results
None listed