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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02974907
Recruitment Status : Completed
First Posted : November 29, 2016
Results First Posted : January 5, 2022
Last Update Posted : January 5, 2022
Sponsor:
Information provided by (Responsible Party):
ReGenTree, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dry Eye Syndrome
Interventions Drug: RGN-259
Drug: Placebo
Enrollment 601
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title RGN-259 Placebo
Hide Arm/Group Description Active (0.1% RGN-259 ophthalmic solution) Placebo (Placebo ophthalmic solution)
Period Title: Overall Study
Started 299 302
Completed 286 292
Not Completed 13 10
Arm/Group Title RGN-259 Placebo Total
Hide Arm/Group Description Active (0.1% RGN-259 ophthalmic solution) Placebo (Placebo ophthalmic solution) Total of all reporting groups
Overall Number of Baseline Participants 299 302 601
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 299 participants 302 participants 601 participants
61.9  (11.97) 63.0  (11.48) 62.5  (11.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 299 participants 302 participants 601 participants
Female
215
  71.9%
223
  73.8%
438
  72.9%
Male
84
  28.1%
79
  26.2%
163
  27.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 299 participants 302 participants 601 participants
Hispanic or Latino
23
   7.7%
24
   7.9%
47
   7.8%
Not Hispanic or Latino
275
  92.0%
278
  92.1%
553
  92.0%
Unknown or Not Reported
1
   0.3%
0
   0.0%
1
   0.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 299 participants 302 participants 601 participants
American Indian or Alaska Native
0
   0.0%
2
   0.7%
2
   0.3%
Asian
9
   3.0%
10
   3.3%
19
   3.2%
Native Hawaiian or Other Pacific Islander
1
   0.3%
1
   0.3%
2
   0.3%
Black or African American
36
  12.0%
41
  13.6%
77
  12.8%
White
251
  83.9%
246
  81.5%
497
  82.7%
More than one race
0
   0.0%
1
   0.3%
1
   0.2%
Unknown or Not Reported
2
   0.7%
1
   0.3%
3
   0.5%
1.Primary Outcome
Title Ocular Discomfort
Hide Description Change from Baseline at Day 29 using the Ora Calibra® Ocular Discomfort Scale (6-point scale where 0 = none and 5 = worst)
Time Frame 29 days after first dosing
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RGN-259 Placebo
Hide Arm/Group Description:
Active (0.1% RGN-259 ophthalmic solution)
Placebo (Placebo ophthalmic solution)
Overall Number of Participants Analyzed 299 302
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
0.07
(-0.05 to 0.19)
-0.04
(-0.15 to 0.08)
2.Primary Outcome
Title Corneal Fluorescein Staining
Hide Description 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)
Time Frame 29 days after first dosing
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RGN-259 Placebo
Hide Arm/Group Description:
Active (0.1% RGN-259 ophthalmic solution)
Placebo (Placebo ophthalmic solution)
Overall Number of Participants Analyzed 111 107
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
0.07
(-0.06 to 0.20)
-0.01
(-0.13 to 0.12)
3.Secondary Outcome
Title Corneal Fluorescein Staining
Hide Description Comparing each of active group & Placebo.
Time Frame 8, 15, 29 days after first dosing
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Unanesthetized Schirmer's Test
Hide Description Comparing each of active group & Placebo.
Time Frame 29 days after first dosing
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Ocular Surface Disease Index (OSDI)©
Hide Description Comparing each of active group & Placebo.
Time Frame 8, 15, 29 days after first dosing
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Tear Film Break-Up Time
Hide Description Comparing each of active group & Placebo.
Time Frame 8, 15, 29 days after first dosing
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Visual Acuity
Hide Description Change or shifts from Baseline
Time Frame 1, 8, 15, 29 days
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Change in Biomicroscopy Using the Slit-lamp
Hide Description Change or shifts from Baseline
Time Frame 1, 8, 15, 29 days
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Adverse Event Query
Hide Description Frequencies
Time Frame 1, 8, 15, 29 days
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Change in Biomicroscopy Using the Undilated Fundoscopy
Hide Description Change or shifts from Baseline
Time Frame 1, 29 days
Outcome Measure Data Not Reported
Time Frame Adverse events were collected at every visit through study completion, up to Day 29.
Adverse Event Reporting Description There was no anticipated/unanticipated deaths due to any cause in this study.
 
Arm/Group Title RGN-259 Placebo
Hide Arm/Group Description Active (0.1% RGN-259 ophthalmic solution) Placebo (Placebo ophthalmic solution)
All-Cause Mortality
RGN-259 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/299 (0.00%)      0/302 (0.00%)    
Hide Serious Adverse Events
RGN-259 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/299 (1.00%)      2/302 (0.66%)    
Ear and labyrinth disorders     
Vertigo   1/299 (0.33%)  1 0/302 (0.00%)  0
Infections and infestations     
Diverticulitis   1/299 (0.33%)  1 0/302 (0.00%)  0
Urinary Tract Infection   0/299 (0.00%)  0 1/302 (0.33%)  1
Metabolism and nutrition disorders     
Hyperglycemia   1/299 (0.33%)  1 0/302 (0.00%)  0
Nervous system disorders     
Transient Ischemic Attack   0/299 (0.00%)  0 1/302 (0.33%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
RGN-259 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/299 (6.35%)      21/302 (6.95%)    
Eye disorders     
Visual Acuity Reduced   1/299 (0.33%)  1 10/302 (3.31%)  12
Eye Pain   3/299 (1.00%)  3 1/302 (0.33%)  1
Infections and infestations     
Nasopharyngitis   9/299 (3.01%)  9 6/302 (1.99%)  6
Sinusitis   3/299 (1.00%)  3 3/302 (0.99%)  3
Upper Respiratory Tract Infection   3/299 (1.00%)  3 1/302 (0.33%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Shinwook Kang
Organization: ReGenTree, LLC
Phone: 609-649-5505
EMail: swkang@regentreellc.com
Layout table for additonal information
Responsible Party: ReGenTree, LLC
ClinicalTrials.gov Identifier: NCT02974907    
Other Study ID Numbers: RGN-259/16-110-0008
First Submitted: November 23, 2016
First Posted: November 29, 2016
Results First Submitted: November 5, 2021
Results First Posted: January 5, 2022
Last Update Posted: January 5, 2022