Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Kera… (NCT02600429) | Clinical Trial Compass
TerminatedPhase 3
Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1
Stopped: Business decision
United States18 participantsStarted 2015-09-17
Plain-language summary
The objective of this study is to assess the safety and efficacy of RGN-259 Ophthalmic Solution compared to placebo for the treatment of NK.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Be male or female of any race, at least 18 years of age
* Have provided verbal and written informed consent.
* Be able and willing to follow instructions, including participation in all study assessments and visits;
* Have stage 2 or 3 neurotrophic keratopathy in at least one eye If a female of childbearing potential, have a negative urine pregnancy test at Visit 1 and agree to use an adequate method of birth control throughout the study period.
Exclusion Criteria:
* Have any clinically significant slit lamp findings at Visit 1 that in the opinion of the investigator may interfere with the study parameters;
* Have significant blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergy that requires treatment
* Have a lid function abnormality (ex. Lagophthalmos) which, in the opinion of the investigator, is the primary cause of the persistent epithelial defect;
* Be diagnosed with ongoing ocular infection (bacterial, viral or fungal) or active inflammation (e.g. follicular conjunctivitis) not related to NK
* Anticipate the use of fluoroquinolone-containing antibiotic eye drops during the study;
* Have used contact lenses (excluding therapeutic contact lenses) within 14 days prior to Visit 1 or anticipates use of contact lenses during the study period;
* Have an uncontrolled systemic disease that in the opinion of the investigator may interfere with the study parameters;
* Anticipate a change in immunosuppressive the…
What they're measuring
1
Percentage of Subjects Achieving Complete Healing at Day 29.