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Study Summary
This trial will study if a drug called RGN-259 is safe and effective in treating a condition called Neurotrophic Keratopathy (NK).
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 3 trial • 601 Patients • NCT02974907Trial Design
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- I agree to use effective birth control.I am 18 years old or older.I do not have an autoimmune or chronic inflammatory disease that could affect the study treatment.I plan to use serum tears in my study eye.I haven't used drugs affecting tear production or facial nerve function in the last 30 days.I have not had eye surgery in the last 3 months.I am planning to have or might need eye surgery during the study.I have an active eye condition that needs treatment and may affect the study.I have a persistent eye surface wound despite treatment.I had eye surgery, except for amniotic membrane transplantation, within the last 3 months.I have not taken immunosuppressive drugs in the last 30 days and likely won't need them during the study.I haven't had a fever, signs of infection, or tested positive for COVID-19 in the last 2 weeks.I don't have any eye or health conditions that could affect the study's treatment or results.I have stage 2 or 3 nerve damage in my eye, not just surface irritation.I have had a fungal eye infection or currently have an eye infection not caused by NK.I received a Botox injection for droopy eyelids in the last 90 days.One of my eyes meets all the required health conditions.I have used Oxervate™ in my eye in the last 2 months.I am not breastfeeding, using birth control, and have a negative pregnancy test.The same eye meets the requirements listed in criteria d, e, f, and g.
- Group 1: 0.1% RGN-259 Opthalmic Solution
- Group 2: Placebo Ophthalmic Solution (Vehicle for RGN-259 Ophthalmic Solution)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the United States Food & Drug Administration given its blessing to 0.1% RGN-259 Opthalmic Solution?
"There is existing clinical evidence that supports the safety of 0.1% RGN-259 Opthalmic Solution, thereby receiving a score of 3 on our scale from one to three."
How many participants are currently partaking in the trial?
"To complete this research, 70 eligible patients are needed. These individuals may enroll through one of the several participating sites like Nvision Clinical Research in Los Angeles or Connecticut Eye Consultants and Danbury Eye Physicians & Surgeons in Florida."
Are researchers currently enrolling participants in this research study?
"Affirmative. Data hosted on clinicaltrials.gov confirms that this medical trial is currently recruiting participants, having first been posted on March 15th 2023 with its most recent update occurring February 21st of the same year. 70 patients must be recruited from 16 distinct sites in order to complete the study."
In which geographic areas can participants access this research?
"Nvision Clinical Research, LLC. in Los Angeles and several other locations such as Connecticut Eye Consultants P.C., Danbury Eye Physicians & Surgeons of Florida, and the University of South Florida Ophthalmology are all partaking in this clinical trial."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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