Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
Study Details
Study Description
Brief Summary
The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
Dry eye can be caused by many variable factors. Some examples include hormonal changes due to aging, or living in an environment of low humidity for long periods of time. Dry eye is a complex disease that may result in symptoms like discomfort, visual disturbance, and dryness. Patients with dry eye often have damage on the surface of the eye. In previous studies, RGN-259 has been shown to promote healing of the surface of the eye and decrease inflammation. It suggests that RGN-259 has a significant potential to be an important new safe and effective therapeutic in the treatment of dry eye syndrome.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: RGN-259 RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4 |
Drug: RGN-259
A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days
Other Names:
|
Placebo Comparator: Placebo It is composed of the same excipients as RGN-259 but does not contain Tβ4 |
Drug: Placebo
It is composed of the same excipients as RGN-259 but does not contain Tβ4
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Ocular Discomfort [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)
- Corneal Fluorescein Staining [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)
Secondary Outcome Measures
- Corneal Fluorescein Staining [8, 15, 29 days after first dosing]
Comparing each of active group & Placebo.
- Unanesthetized Schirmer's Test [29 days after first dosing]
Comparing each of active group & Placebo.
- Ocular Surface Disease Index (OSDI)© [8, 15, 29 days after first dosing]
Comparing each of active group & Placebo.
- Tear Film Break-Up Time [8, 15, 29 days after first dosing]
Comparing each of active group & Placebo.
Other Outcome Measures
- Visual Acuity [1, 8, 15, 29 days]
Change or shifts from Baseline
- Change in Biomicroscopy Using the Slit-lamp [1, 8, 15, 29 days]
Change or shifts from Baseline
- Adverse Event Query [1, 8, 15, 29 days]
Frequencies
- Change in Biomicroscopy Using the Undilated Fundoscopy [1, 29 days]
Change or shifts from Baseline
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Be at least 18 years of age;
-
Provide written informed consent;
-
Have a subject reported history of dry eye for at least 6 months
-
Have a history of use or desire to use eye drops for dry eye symptoms within 6 months
Exclusion Criteria:
-
Have any clinically significant slit-lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
-
Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
-
Have ab uncontrolled systemic disease:
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Andover, MA | Andover | Massachusetts | United States | 01810 |
Sponsors and Collaborators
- ReGenTree, LLC
Investigators
- Principal Investigator: Gail Torkildsen, MD, Ora Clinical Research and Development
Study Documents (Full-Text)
More Information
Publications
None provided.- RGN-259/16-110-0008
Study Results
Participant Flow
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 Detail |
Arm/Group Title | RGN-259 | Placebo |
---|---|---|
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 |
Baseline Characteristics
Arm/Group Title | RGN-259 | Placebo | Total |
---|---|---|---|
Arm/Group Description | Active (0.1% RGN-259 ophthalmic solution) | Placebo (Placebo ophthalmic solution) | Total of all reporting groups |
Overall Participants | 299 | 302 | 601 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
61.9
(11.97)
|
63.0
(11.48)
|
62.5
(11.73)
|
Sex: Female, Male (Count of Participants) | |||
Female |
215
71.9%
|
223
73.8%
|
438
72.9%
|
Male |
84
28.1%
|
79
26.2%
|
163
27.1%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
23
7.7%
|
24
7.9%
|
47
7.8%
|
Not Hispanic or Latino |
275
92%
|
278
92.1%
|
553
92%
|
Unknown or Not Reported |
1
0.3%
|
0
0%
|
1
0.2%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
2
0.7%
|
2
0.3%
|
Asian |
9
3%
|
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%
|
41
13.6%
|
77
12.8%
|
White |
251
83.9%
|
246
81.5%
|
497
82.7%
|
More than one race |
0
0%
|
1
0.3%
|
1
0.2%
|
Unknown or Not Reported |
2
0.7%
|
1
0.3%
|
3
0.5%
|
Outcome Measures
Title | Ocular Discomfort |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | RGN-259 | Placebo |
---|---|---|
Arm/Group Description | Active (0.1% RGN-259 ophthalmic solution) | Placebo (Placebo ophthalmic solution) |
Measure Participants | 299 | 302 |
Mean (95% Confidence Interval) [score on a scale] |
0.07
|
-0.04
|
Title | Corneal Fluorescein Staining |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | RGN-259 | Placebo |
---|---|---|
Arm/Group Description | Active (0.1% RGN-259 ophthalmic solution) | Placebo (Placebo ophthalmic solution) |
Measure Participants | 111 | 107 |
Mean (95% Confidence Interval) [score on a scale] |
0.07
|
-0.01
|
Title | Corneal Fluorescein Staining |
---|---|
Description | Comparing each of active group & Placebo. |
Time Frame | 8, 15, 29 days after first dosing |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Unanesthetized Schirmer's Test |
---|---|
Description | Comparing each of active group & Placebo. |
Time Frame | 29 days after first dosing |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Ocular Surface Disease Index (OSDI)© |
---|---|
Description | Comparing each of active group & Placebo. |
Time Frame | 8, 15, 29 days after first dosing |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Tear Film Break-Up Time |
---|---|
Description | Comparing each of active group & Placebo. |
Time Frame | 8, 15, 29 days after first dosing |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Visual Acuity |
---|---|
Description | Change or shifts from Baseline |
Time Frame | 1, 8, 15, 29 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Change in Biomicroscopy Using the Slit-lamp |
---|---|
Description | Change or shifts from Baseline |
Time Frame | 1, 8, 15, 29 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Adverse Event Query |
---|---|
Description | Frequencies |
Time Frame | 1, 8, 15, 29 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Change in Biomicroscopy Using the Undilated Fundoscopy |
---|---|
Description | Change or shifts from Baseline |
Time Frame | 1, 29 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Adverse Events
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 | ||
Arm/Group Description | Active (0.1% RGN-259 ophthalmic solution) | Placebo (Placebo ophthalmic solution) | ||
All Cause Mortality |
||||
RGN-259 | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/299 (0%) | 0/302 (0%) | ||
Serious Adverse Events |
||||
RGN-259 | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 3/299 (1%) | 2/302 (0.7%) | ||
Ear and labyrinth disorders | ||||
Vertigo | 1/299 (0.3%) | 1 | 0/302 (0%) | 0 |
Infections and infestations | ||||
Diverticulitis | 1/299 (0.3%) | 1 | 0/302 (0%) | 0 |
Urinary Tract Infection | 0/299 (0%) | 0 | 1/302 (0.3%) | 1 |
Metabolism and nutrition disorders | ||||
Hyperglycemia | 1/299 (0.3%) | 1 | 0/302 (0%) | 0 |
Nervous system disorders | ||||
Transient Ischemic Attack | 0/299 (0%) | 0 | 1/302 (0.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
RGN-259 | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 19/299 (6.4%) | 21/302 (7%) | ||
Eye disorders | ||||
Visual Acuity Reduced | 1/299 (0.3%) | 1 | 10/302 (3.3%) | 12 |
Eye Pain | 3/299 (1%) | 3 | 1/302 (0.3%) | 1 |
Infections and infestations | ||||
Nasopharyngitis | 9/299 (3%) | 9 | 6/302 (2%) | 6 |
Sinusitis | 3/299 (1%) | 3 | 3/302 (1%) | 3 |
Upper Respiratory Tract Infection | 3/299 (1%) | 3 | 1/302 (0.3%) | 1 |
Limitations/Caveats
More Information
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
Name/Title | Shinwook Kang |
---|---|
Organization | ReGenTree, LLC |
Phone | 609-649-5505 |
swkang@regentreellc.com |
- RGN-259/16-110-0008