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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 8, 15, 22, 29, 36, and 43
Awards & highlights
Pivotal Trial
Summary
This trial will study if a drug called RGN-259 is safe and effective in treating a condition called Neurotrophic Keratopathy (NK).
Who is the study for?
Adults with stage 2 or 3 neurotrophic keratopathy (NK) in one eye, confirmed not to be just superficial damage. They must have reduced corneal sensitivity and a specific level of vision impairment. Participants need to agree to contraception use and can't have lid abnormalities, active infections/inflammation unrelated to NK, recent ocular surgery, or conditions that might affect the study's outcome.
What is being tested?
The trial is testing RGN-259 ophthalmic solution against a placebo for treating NK. The goal is to see if RGN-259 is safe and works better than a placebo in healing the eye condition.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include typical reactions related to ophthalmic solutions such as eye irritation, discomfort, redness, or allergic responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, 8, 15, 22, 29, 36, and 43
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 8, 15, 22, 29, 36, and 43
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
NK stage by Mackie classification
Percentage change from baseline of lesion size
Percentage of subjects achieving complete healing of PED at Day 29
+1 moreOther study objectives
Choroid
Frequency and severity of AEs
Number of participants with abnormal vital signs
+1 moreSide effects data
From 2018 Phase 3 trial • 601 Patients • NCT029749073%
Nasopharyngitis
1%
Eye Pain
1%
Upper Respiratory Tract Infection
1%
Sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
RGN-259
Placebo
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 0.1% RGN-259 Opthalmic SolutionExperimental Treatment1 Intervention
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into study eye(s), five times per day for 28 days
Group II: Placebo Ophthalmic Solution (Vehicle for RGN-259 Ophthalmic Solution)Placebo Group1 Intervention
It is composed of the same excipients as RGN-259 but does not contain Tβ4
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RGN-259
2019
Completed Phase 3
~1620
Find a Location
Who is running the clinical trial?
ReGenTree, LLCLead Sponsor
6 Previous Clinical Trials
1,720 Total Patients Enrolled
1 Trials studying Neurotrophic Keratopathy
18 Patients Enrolled for Neurotrophic Keratopathy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: 0.1% RGN-259 Opthalmic Solution
- Group 2: Placebo Ophthalmic Solution (Vehicle for RGN-259 Ophthalmic Solution)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
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