NCT02600429|TerminatedPhase 3Results
Study Stopped
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Phase 3, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of RGN-259 Ophthalmic Solution for the Treatment of Neurotrophic Keratopathy: SEER-1
Sponsor study identifier
interventional
18
1 country
11
Study Start
September 17, 2015
Actual (reported)Primary Completion
November 20, 2019
Actual (reported)Study Completion
March 9, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 9, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 17, 2015
Actual (reported)October 26, 2015
Actual (reported)November 9, 2015
Actual (reported)November 20, 2019
Actual (reported)March 9, 2020
Actual (reported)August 14, 2023
Actual (reported)Percentage of Subjects Achieving Complete Healing at Day 29.
Percentage of subjects achieving complete healing of the persistent epithelial defect as determined by corneal fluorescein staining at day 29 after first dosing.
29 days after first dosing
Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days
8, 15, 22, 36, 43 days after first dosing
Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification.
8, 15, 22, 29, 36, 43 days after first dosing
Tear Film Break-up Time at 29, 36, 43 Days
29, 36, 43 days after first dosing
Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing
8, 15, 22, 29, 36, 43 days after first dosing
Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days
8, 15, 22, 29, 36, 43 days after first dosing
The Number of Participants With an Abnormal Findings by Slit-lamp Biomicroscopy at 8, 15, 22, 29, 36, 43 Days
8, 15, 22, 29, 36, 43 days after first dosing
Corneal Sensitivity Using the Aesthesiometer (Cochet-Bonnet)
29, 43 days after first dosing
The Number of Participants With an Abnormal Findings by Dilated Fundoscopy at 29, 43 Days
29, 43 days after first dosing
It is a preservative-free, sterile eye drop solution containing Tβ4
It is composed of the same excipients as RGN-259 but does not contain Tβ4.
A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into affected eye(s), five times a day for 4 weeks.
It is composed of the same excipients as RGN-259 but does not contain Tβ4
Hull Eye Center
Lancaster, California, 93534, United States
Vision Institute
Colorado Springs, Colorado, 80907, United States
Eye Center of Northern Colorado
Fort Collins, Colorado, 80525, United States
Insight Vision Group
Parker, Colorado, 80134, United States
Medical Faculty Associates, Inc.
Washington D.C., District of Columbia, 20037, United States
Midwest Cornea Associates, LLC
Indianapolis, Indiana, 46290, United States
Koffler Vision Group
Lexington, Kentucky, 40509, United States
18 participants (actual enrollment reported by the registry).
First Submitted
October 26, 2015
First Posted
November 9, 2015
Study Start
September 17, 2015
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Richard Eiferman, MD, PSC
Louisville, Kentucky, 40205, United States
The Eye Care Institute
Louisville, Kentucky, 40206, United States
Central Maine Eye Care
Lewiston, Maine, 04240, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Primary Completion
November 20, 2019
Actual (reported)Study Completion
March 9, 2020
Actual (reported)Last Updated
August 30, 2023
Results First Posted
August 14, 2023
Record last verified: 2023-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
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