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

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.

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.

Study Overview

• Status: Completed
• Conditions: Corneal re-Epithelialization
• Intervention / Treatment: Drug: Nexagon™ or Nexagon™ vehicle

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 1001
    • Auckland Eye Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	Drug: Nexagon™ or Nexagon™ vehicle; Dose-escalation design in which cohorts of 6 subjects will be studied sequentially.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	30 days post-application

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the clinical effect of Nexagon™	30 days post-application

Collaborators and Investigators

• Sponsor: OcuNexus Therapeutics, Inc.
• Investigators: Principal Investigator: Sue Ormonde, MD, FRC Ophth, FRANZCO, Auckland Eye

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ACTUAL): September 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: April 3, 2008
• First Submitted That Met QC Criteria: April 3, 2008
• First Posted (ESTIMATE): April 8, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): January 8, 2009
• Last Update Submitted That Met QC Criteria: January 6, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: Nexagon; PRK; Re-epithelialization; Photorefractive keratectomy; Coda
• Other Study ID Numbers: NEX-OCU-001