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

Sponsored by:	CoDa Therapeutics Inc.
Information provided by:	CoDa Therapeutics Inc.
ClinicalTrials.gov Identifier:	NCT00654550

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 I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
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
1: Experimental	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:	CoDaTherapeutics ( Scott Bannan )
Study ID Numbers:	NEX-OCU-001
Study First Received:	April 3, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00654550 History of Changes
Health Authority:	United States: Food and Drug Administration; New Zealand: Medsafe

Keywords provided by CoDa Therapeutics Inc.:

Photorefractive keratectomy
Re-epithelialization
Nexagon
PRK
Coda

Study placed in the following topic categories:

Myopia

ClinicalTrials.gov processed this record on May 07, 2009