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

• ClinicalTrials.gov Identifier: NCT00654550
• Recruitment Status: Completed
• First Posted: April 8, 2008
• Last Update Posted: January 8, 2009
• Sponsor: OcuNexus Therapeutics, Inc.
• Information provided by: OcuNexus Therapeutics, Inc.

Tracking Information

• First Submitted Date: April 3, 2008
• First Posted Date: April 8, 2008
• Last Update Posted Date: January 8, 2009
• Study Start Date: April 2008
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 3, 2008): Incidence of adverse events [ Time Frame: 30 days post-application ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: August 14, 2008): To evaluate the clinical effect of Nexagon™ [ Time Frame: 30 days post-application ]
• Original Secondary Outcome Measures (submitted: April 3, 2008): To evaluate the clinical effect of Nexagon [ Time Frame: 30 days post-application ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Assess the Safety, Tolerability and Effect of Nexagon™ Applied to the Eye After PRK Laser Eye Surgery for Nearsightedness
• Official Title: 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.
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Corneal re-Epithelialization

Intervention

Drug: Nexagon™ or Nexagon™ vehicle

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

Study Arms

Experimental: 1

Intervention: Drug: Nexagon™ or Nexagon™ vehicle

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: April 3, 2008): 24
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2008
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: New Zealand

Administrative Information

• NCT Number: NCT00654550
• Other Study ID Numbers: NEX-OCU-001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Scott Bannan, CoDaTherapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: OcuNexus Therapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sue Ormonde, MD, FRC Ophth, FRANZCO; Auckland Eye

• PRS Account: OcuNexus Therapeutics, Inc.
• Verification Date: January 2009