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A Study to Assess the Safety, Tolerability and Effect of Nexagon™ Applied to the Eye After PRK Laser Eye Surgery for Nearsightedness

NCT00654550 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2009-01-08

No results posted yet for this study

Summary

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.

Conditions

  • Corneal re-Epithelialization

Interventions

DRUG

Nexagon™ or Nexagon™ vehicle

Dose-escalation design in which cohorts of 6 subjects will be studied sequentially.

Sponsors & Collaborators

  • OcuNexus Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Sue Ormonde, MD, FRC Ophth, FRANZCO · Auckland Eye

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-09-30
Completion
2008-12-31

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00654550 on ClinicalTrials.gov