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

NCT ID: NCT00654550

Last Updated: 2009-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2008-12-31

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.

Conditions

Corneal re-Epithelialization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Group Type: EXPERIMENTAL

Nexagon™ or Nexagon™ vehicle

Intervention Type: DRUG

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

Interventions

Nexagon™ or Nexagon™ vehicle

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OcuNexus Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

CoDaTherapeutics

Principal Investigators

Sue Ormonde, MD, FRC Ophth, FRANZCO

Role: PRINCIPAL_INVESTIGATOR

Auckland Eye

Locations

Auckland Eye Limited

Auckland, , New Zealand

Countries

New Zealand

Other Identifiers

NEX-OCU-001

Identifier Type: -

Identifier Source: org_study_id