Corneal re-Epithelialization Clinical Trial
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.
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.
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | December 2008 |
| Est. primary completion date | September 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 50 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| New Zealand | Auckland Eye Limited | Auckland |
| Lead Sponsor | Collaborator |
|---|---|
| CoDa Therapeutics Inc. |
New Zealand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of adverse events | 30 days post-application | Yes | |
| Secondary | To evaluate the clinical effect of Nexagon™ | 30 days post-application | No |