A Study to Assess the Safety, Tolerability and Effect of Nexagon™ Applied to the Eye After PRK Laser Eye Surgery for Nearsightedness
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: Nexagon™ or Nexagon™ vehicle
Dose-escalation design in which cohorts of 6 subjects will be studied sequentially.
|
Outcome Measures
Primary Outcome Measures
- Incidence of adverse events [30 days post-application]
Secondary Outcome Measures
- To evaluate the clinical effect of Nexagon™ [30 days post-application]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female pre-presbyopic myopes.
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Aged between 20 and 50 years inclusive.
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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.
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Subjects willing and able to undergo bilateral PRK for the correction of their myopia.
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Subjects with MRSE <6.0 D, with less than 2.0 D of astigmatism.
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No more than 1.0 D of refractive difference between eyes.
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Stable prescription in both eyes as defined by <0.25 D change over the preceding 2 years.
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Subjects who are able to comply with all study procedures, including wearing a soft bandage contact lens in the immediate postoperative period.
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Subjects who are willing and able to give written informed consent to take part in the study.
Exclusion Criteria:
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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.
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Subjects who have previously had corneal surgery.
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Subjects who require Mitomycin C following their PRK.
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Subjects with any ocular disease or corneal abnormality, including but not limited to:
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Decreased corneal sensation / neurotrophic cornea;
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Corneal vascularization;
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Keratoconus;
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Keratoconjunctivitis sicca requiring chronic treatment;
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Lagophthalmos;
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Blepharitis;
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History of infectious keratitis;
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History of glaucoma or intraocular pressure of >21 mmHg or use of glaucoma medications;
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Significant dry eye disease that requires regular topical treatment;
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Corneal thickness <480 µm at the thinnest point, and
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Posterior elevation >40 mmHg.
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Subjects with corneal haze >+1 as assessed using the grading scale in the protocol.
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Subjects who require any topical ophthalmic medication other than the pre- and postoperative regimen defined in the study protocol.
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Subjects with:
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Diabetes;
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Collagen disorders associated with autoimmune diseases, e.g., lupus, rheumatoid arthritis;
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Severe atopic disease;
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Any systemic disease or condition where the subject is immunocompromized.
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Subjects who require any systemic medication that affects healing, e.g., steroids, hormone replacement therapy.
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Subjects who are taking amiodarone, long acting anticholinergics, e.g., atropine, scopolamine, or medications or agents that can cause dry eye.
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Subjects who have participated in a clinical trial within the 30 days prior to the date on which PRK is scheduled.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Auckland Eye Limited | Auckland | New Zealand | 1001 |
Sponsors and Collaborators
- OcuNexus Therapeutics, Inc.
Investigators
- Principal Investigator: Sue Ormonde, MD, FRC Ophth, FRANZCO, Auckland Eye
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NEX-OCU-001