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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Corneal re-Epithelialization

Intervention / Treatment
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* Drug: Nexagon™ or Nexagon™ vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Nexagon™ or Nexagon™ vehicle<br>* Dose-escalation design in which cohorts of 6 subjects will be studied sequentially.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | 30 days post-application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the clinical effect of Nexagon™ |  | 30 days post-application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Photorefractive keratectomy, Re-epithelialization, Nexagon, PRK, Coda