A Study to Compare the Safety and Efficacy of a New Eye Drop Formulation With REFRESH PLUS® in Participants Following LASIK Refractive Surgery

Study Identifier
11002X-002
CT.gov Identifier
NCT01886690
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Eye Care - Other
    • Study Drug
  • carboxymethylcellulose sodium based new eye drop formulation
  • carboxymethylcellulose sodium based eye drops
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 60 Years
    Inclusion and Exclusion 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.

    Protocol Summary

    This study will compare the safety and efficacy of a new eye drop formulation with REFRESH PLUS® in participants following LASIK surgery.

    Study Locations

    Location
    Status
    Location
    New South Wales, Australia
    Status
    Not applicable
    Location
    Kelowna, British Columbia, Canada
    Status
    Not applicable