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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00654550
Recruitment Status : Completed
First Posted : April 8, 2008
Last Update Posted : January 8, 2009
Sponsor:
Information provided by:
OcuNexus Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Corneal re-Epithelialization Drug: Nexagon™ or Nexagon™ vehicle Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : April 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Nexagon™ or Nexagon™ vehicle
Dose-escalation design in which cohorts of 6 subjects will be studied sequentially.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 30 days post-application ]

Secondary Outcome Measures :
  1. To evaluate the clinical effect of Nexagon™ [ Time Frame: 30 days post-application ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654550


Locations
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New Zealand
Auckland Eye Limited
Auckland, New Zealand, 1001
Sponsors and Collaborators
OcuNexus Therapeutics, Inc.
Investigators
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Principal Investigator: Sue Ormonde, MD, FRC Ophth, FRANZCO Auckland Eye
More Information
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Responsible Party: Scott Bannan, CoDaTherapeutics
ClinicalTrials.gov Identifier: NCT00654550    
Other Study ID Numbers: NEX-OCU-001
First Posted: April 8, 2008    Key Record Dates
Last Update Posted: January 8, 2009
Last Verified: January 2009
Keywords provided by OcuNexus Therapeutics, Inc.:
Photorefractive keratectomy
Re-epithelialization
Nexagon
PRK
Coda