Status:
COMPLETED
A Study to Assess the Safety, Tolerability and Effect of Nexagon™ Applied to the Eye After PRK Laser Eye Surgery for Nearsightedness
Lead Sponsor:
OcuNexus Therapeutics, Inc.
Conditions:
Corneal re-Epithelialization
Eligibility:
All Genders
20-50 years
Phase:
PHASE1
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00654550
Start Date
April 1 2008
End Date
December 1 2008
Last Update
January 8 2009
Active Locations (1)
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1
Auckland Eye Limited
Auckland, New Zealand, 1001