A Study to Assess the Safety, Tolerability and Effect of Nexagon™ Applied to the Eye After PRK La… (NCT00654550) | Clinical Trial Compass
CompletedPhase 1
A Study to Assess the Safety, Tolerability and Effect of Nexagon™ Applied to the Eye After PRK Laser Eye Surgery for Nearsightedness
New Zealand24 participantsStarted 2008-04
Plain-language 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.
Who can participate
Age range20 Years – 50 Years
SexALL
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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 …