Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
CoDa Therapeutics Inc. |
---|---|
Information provided by: | CoDa Therapeutics Inc. |
ClinicalTrials.gov Identifier: | NCT00654550 |
Phase 1 randomized, prospective, double-masked, vehicle-controlled, dose-escalation study to evaluate the safety, tolerability and clinical effect of Nexagon™ in subjects following bilateral PRK for the correction of mild to moderate myopia.
Condition | Intervention | Phase |
---|---|---|
Corneal re-Epithelialization |
Drug: Nexagon™ or Nexagon™ vehicle |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Phase 1 Randomized, Prospective, Double-Masked, Vehicle-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability and Clinical Effect of Nexagon™ in Subjects Following Bilateral Photorefractive Keratectomy (PRK) for the Correction of Mild to Moderate Myopia. |
Estimated Enrollment: | 24 |
Study Start Date: | April 2008 |
Study Completion Date: | December 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Nexagon™ or Nexagon™ vehicle
Dose-escalation design in which cohorts of 6 subjects will be studied sequentially.
|
Ages Eligible for Study: | 20 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects with any ocular disease or corneal abnormality, including but not limited to:
Subjects with:
Responsible Party: | CoDaTherapeutics ( Scott Bannan ) |
Study ID Numbers: | NEX-OCU-001 |
Study First Received: | April 3, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00654550 History of Changes |
Health Authority: | United States: Food and Drug Administration; New Zealand: Medsafe |
Photorefractive keratectomy Re-epithelialization Nexagon PRK Coda |
Myopia |