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

NCT00654550 | Completed Phase 1

• 1 other identifier: NEX-OCU-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Photorefractive keratectomy; Re-epithelialization; Nexagon; PRK; Coda

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  30 days post-application

Secondary Outcomes (1)

• To evaluate the clinical effect of Nexagon™

  30 days post-application

Study Arms (1)

1

EXPERIMENTAL

Drug: Nexagon™ or Nexagon™ vehicle

Interventions

Nexagon™ or Nexagon™ vehicle DRUG

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

1

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OcuNexus Therapeutics, Inc.: lead

Study Sites (1)

Auckland Eye Limited

Auckland, 1001, New Zealand

Location

MeSH Terms

Conditions

Cavitary Optic Disc Anomalies

Study Officials

• Sue Ormonde, MD, FRC Ophth, FRANZCO

  Auckland Eye

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 8, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 8, 2009

Record last verified: 2009-01

Locations

NZ (1)