Corneal re-Epithelialization
Conditions
Keywords
Photorefractive keratectomy, Re-epithelialization, Nexagon, PRK, Coda
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.
Interventions
Dose-escalation design in which cohorts of 6 subjects will be studied sequentially.
Sponsors
OcuNexus Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | 30 days post-application |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the clinical effect of Nexagon™ | 30 days post-application |
Countries
New Zealand
Outcome results
None listed