Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy
NCT ID: NCT00349440
Last Updated: 2008-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
93 participants
INTERVENTIONAL
2006-09-30
2008-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients
NCT00611403
Study of Cyclosporine in Post-LASIK Patients
NCT00991458
Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy
NCT02121847
Efficacy of Cyclosporine Ophthalmic Emulsion in the Treatment of Dry Eye Syndrome in Contact Lens Wearers
NCT00335114
Comparison of Efficacy, Safety and Anti-Inflammatory Effect Between Topical 0.05%Cyclosporine A Emulsion and REFRESH® in Patients With Moderate to Severe Dry Eyes
NCT00704275
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Cyclosporine, Refresh Plus
Cyclosporine 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.
Refresh Plus 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.
2
Cyclosporine, Refresh Plus
Cyclosporine 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.
Refresh Plus 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cyclosporine, Refresh Plus
Cyclosporine 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.
Refresh Plus 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Mild-moderate symptoms of dry eye prior to surgery
* Scheduled to undergo bilateral LASIK or PRK
* Likely to complete all study visits and able to provide informed consent
Exclusion Criteria
* Known contraindications to any study medication or ingredients
* Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
* Ocular disorders
* Active ocular diseases or uncontrolled systemic disease
* Active ocular allergies
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Innovative Medical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Southeastern Laser and Refractive Surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karl Stonecipher, MD
Role: PRINCIPAL_INVESTIGATOR
Southeastern Laser and Refractive Surgery
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Southeastern Laser and Refractive Surgery
Greensboro, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1121
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.