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

Ocunexus Therapeutics

Status and phase

Completed

Phase 1

Conditions

Corneal re-Epithelialization

Treatments

Drug: Nexagon™ or Nexagon™ vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT00654550

NEX-OCU-001

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

20 to 50 years old

Volunteers

No Healthy Volunteers

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.