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

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

Tracking Information
First Submitted Date  ICMJE April 3, 2008
First Posted Date  ICMJE April 8, 2008
Last Update Posted Date January 8, 2009
Study Start Date  ICMJE April 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
Incidence of adverse events [ Time Frame: 30 days post-application ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2008)
To evaluate the clinical effect of Nexagon™ [ Time Frame: 30 days post-application ]
Original Secondary Outcome Measures  ICMJE
 (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  ICMJE A Study to Assess the Safety, Tolerability and Effect of Nexagon™ Applied to the Eye After PRK Laser Eye Surgery for Nearsightedness
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Corneal re-Epithelialization
Intervention  ICMJE Drug: Nexagon™ or Nexagon™ vehicle
Dose-escalation design in which cohorts of 6 subjects will be studied sequentially.
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Nexagon™ or Nexagon™ vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 3, 2008)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE New Zealand
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00654550
Other Study ID Numbers  ICMJE NEX-OCU-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Scott Bannan, CoDaTherapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE OcuNexus Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sue Ormonde, MD, FRC Ophth, FRANZCO Auckland Eye
PRS Account OcuNexus Therapeutics, Inc.
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP