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

This study has been completed.
Sponsor:
Information provided by:
CoDa Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00654550
First received: April 3, 2008
Last updated: January 6, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Corneal re-Epithelialization
Drug: Nexagon™ or Nexagon™ vehicle
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Further study details as provided by CoDa Therapeutics Inc.:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 30 days post-application ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the clinical effect of Nexagon™ [ Time Frame: 30 days post-application ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: April 2008
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Nexagon™ or Nexagon™ vehicle
Dose-escalation design in which cohorts of 6 subjects will be studied sequentially.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654550

Locations
New Zealand
Auckland Eye Limited
Auckland, New Zealand, 1001
Sponsors and Collaborators
CoDa Therapeutics Inc.
Investigators
Principal Investigator: Sue Ormonde, MD, FRC Ophth, FRANZCO Auckland Eye
  More Information

No publications provided

Responsible Party: Scott Bannan, CoDaTherapeutics
ClinicalTrials.gov Identifier: NCT00654550     History of Changes
Other Study ID Numbers: NEX-OCU-001
Study First Received: April 3, 2008
Last Updated: January 6, 2009
Health Authority: United States: Food and Drug Administration
New Zealand: Medsafe

Keywords provided by CoDa Therapeutics Inc.:
Photorefractive keratectomy
Re-epithelialization
Nexagon
PRK
Coda

ClinicalTrials.gov processed this record on April 22, 2014