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

Phase 1

Completed

• Conditions: Corneal re-Epithelialization
• Interventions: Drug: Nexagon™ or Nexagon™ vehicle

• Registration Number: NCT00654550
• Lead Sponsor: OcuNexus Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-08
• Primary Completion: 2008-09
• Study Completion: 2008-12
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-06
• Last Update Posted: 2009-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Male or female pre-presbyopic myopes.
• Aged between 20 and 50 years inclusive.
• Females are eligible to participate only if they are currently non-pregnant and non-lactating. Females of child-bearing potential must commit to consistent and correct use of an acceptable method of birth control.
• Subjects willing and able to undergo bilateral PRK for the correction of their myopia.
• Subjects with MRSE <6.0 D, with less than 2.0 D of astigmatism.
• No more than 1.0 D of refractive difference between eyes.
• Stable prescription in both eyes as defined by <0.25 D change over the preceding 2 years.
• Subjects who are able to comply with all study procedures, including wearing a soft bandage contact lens in the immediate postoperative period.
• Subjects who are willing and able to give written informed consent to take part in the study.

Exclusion Criteria

• Subjects who have a past or present disease, which as judged by the investigator may affect the safety of the subject or the outcome of the study.

• Subjects who have previously had corneal surgery.

• Subjects who require Mitomycin C following their PRK.

• Subjects with any ocular disease or corneal abnormality, including but not limited to:

  • Decreased corneal sensation / neurotrophic cornea;
  • Corneal vascularization;
  • Keratoconus;
  • Keratoconjunctivitis sicca requiring chronic treatment;
  • Lagophthalmos;
  • Blepharitis;
  • History of infectious keratitis;
  • History of glaucoma or intraocular pressure of >21 mmHg or use of glaucoma medications;
  • Significant dry eye disease that requires regular topical treatment;
  • Corneal thickness <480 µm at the thinnest point, and
  • Posterior elevation >40 mmHg.

• Subjects with corneal haze >+1 as assessed using the grading scale in the protocol.

• Subjects who require any topical ophthalmic medication other than the pre- and postoperative regimen defined in the study protocol.

• Subjects with:

  • Diabetes;
  • Collagen disorders associated with autoimmune diseases, e.g., lupus, rheumatoid arthritis;
  • Severe atopic disease;
  • Any systemic disease or condition where the subject is immunocompromized.

• Subjects who require any systemic medication that affects healing, e.g., steroids, hormone replacement therapy.

• Subjects who are taking amiodarone, long acting anticholinergics, e.g., atropine, scopolamine, or medications or agents that can cause dry eye.

• Subjects who have participated in a clinical trial within the 30 days prior to the date on which PRK is scheduled.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Nexagon™ or Nexagon™ vehicle	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	30 days post-application

Secondary Outcome Measures

Name	Time	Method
To evaluate the clinical effect of Nexagon™	30 days post-application

Trial Locations

Locations (1)

Auckland Eye Limited; 🇳🇿 Auckland, New Zealand