Trial Outcomes & Findings for Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2 (NCT NCT02974907)

Results Overview

Change from Baseline at Day 29 using the Ora Calibra® Ocular Discomfort Scale (6-point scale where 0 = none and 5 = worst)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

601 participants

Primary outcome timeframe

29 days after first dosing

Results posted on

2022-01-05

Participant Flow

Subjects were screened during a 14-day study run-in period prior to randomization. And after run-in period and confirmation of inclusion and exclusion criteria, all eligible subjects were randomized in a 1:1 ratio to receive 0.1% RGN-259 or placebo ophthalmic solution bilaterally, four times per day (QID) for 28 days. The study comprised of 5 visits over the course of approximately 6 weeks.

Participant milestones

Participant milestones
Measure	RGN-259 Active (0.1% RGN-259 ophthalmic solution)	Placebo Placebo (Placebo ophthalmic solution)
Overall Study STARTED	299	302
Overall Study COMPLETED	286	292
Overall Study NOT COMPLETED	13	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RGN-259 n=299 Participants Active (0.1% RGN-259 ophthalmic solution)	Placebo n=302 Participants Placebo (Placebo ophthalmic solution)	Total n=601 Participants Total of all reporting groups
Age, Continuous	61.9 years STANDARD_DEVIATION 11.97 • n=5 Participants	63.0 years STANDARD_DEVIATION 11.48 • n=7 Participants	62.5 years STANDARD_DEVIATION 11.73 • n=5 Participants
Sex: Female, Male Female	215 Participants n=5 Participants	223 Participants n=7 Participants	438 Participants n=5 Participants
Sex: Female, Male Male	84 Participants n=5 Participants	79 Participants n=7 Participants	163 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	275 Participants n=5 Participants	278 Participants n=7 Participants	553 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	36 Participants n=5 Participants	41 Participants n=7 Participants	77 Participants n=5 Participants
Race (NIH/OMB) White	251 Participants n=5 Participants	246 Participants n=7 Participants	497 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 29 days after first dosing

Change from Baseline at Day 29 using the Ora Calibra® Ocular Discomfort Scale (6-point scale where 0 = none and 5 = worst)

Outcome measures

Outcome measures
Measure	RGN-259 n=299 Participants Active (0.1% RGN-259 ophthalmic solution)	Placebo n=302 Participants Placebo (Placebo ophthalmic solution)
Ocular Discomfort	0.07 score on a scale Interval -0.05 to 0.19	-0.04 score on a scale Interval -0.15 to 0.08

PRIMARY outcome

Timeframe: 29 days after first dosing

Change from Baseline at Day 29 using the Ora Calibra® scale (5-point scale with half (0.5) increments where 0 = none and 4 = severe)

Outcome measures

Outcome measures
Measure	RGN-259 n=111 Participants Active (0.1% RGN-259 ophthalmic solution)	Placebo n=107 Participants Placebo (Placebo ophthalmic solution)
Corneal Fluorescein Staining	0.07 score on a scale Interval -0.06 to 0.2	-0.01 score on a scale Interval -0.13 to 0.12

Adverse Events

RGN-259

Serious events: 3 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RGN-259 n=299 participants at risk Active (0.1% RGN-259 ophthalmic solution)	Placebo n=302 participants at risk Placebo (Placebo ophthalmic solution)
Infections and infestations Diverticulitis	0.33% 1/299 • Number of events 1 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.	0.00% 0/302 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.
Infections and infestations Urinary Tract Infection	0.00% 0/299 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.	0.33% 1/302 • Number of events 1 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.
Ear and labyrinth disorders Vertigo	0.33% 1/299 • Number of events 1 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.	0.00% 0/302 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.
Metabolism and nutrition disorders Hyperglycemia	0.33% 1/299 • Number of events 1 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.	0.00% 0/302 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.
Nervous system disorders Transient Ischemic Attack	0.00% 0/299 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.	0.33% 1/302 • Number of events 1 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.

Other adverse events

Other adverse events
Measure	RGN-259 n=299 participants at risk Active (0.1% RGN-259 ophthalmic solution)	Placebo n=302 participants at risk Placebo (Placebo ophthalmic solution)
Eye disorders Visual Acuity Reduced	0.33% 1/299 • Number of events 1 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.	3.3% 10/302 • Number of events 12 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.
Eye disorders Eye Pain	1.0% 3/299 • Number of events 3 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.	0.33% 1/302 • Number of events 1 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.
Infections and infestations Nasopharyngitis	3.0% 9/299 • Number of events 9 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.	2.0% 6/302 • Number of events 6 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.
Infections and infestations Sinusitis	1.0% 3/299 • Number of events 3 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.	0.99% 3/302 • Number of events 3 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.
Infections and infestations Upper Respiratory Tract Infection	1.0% 3/299 • Number of events 3 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.	0.33% 1/302 • Number of events 1 • Adverse events were collected at every visit through study completion, up to Day 29. There was no anticipated/unanticipated deaths due to any cause in this study.

Additional Information

Shinwook Kang

ReGenTree, LLC

Phone: 609-649-5505

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place