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 range
20 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.