Dry Eye Syndrome
Conditions
Keywords
Dry Eye Syndrome, Dry Eye, DES
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.
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.
Interventions
DRUGRGN-259
A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days
DRUGPlacebo
It is composed of the same excipients as RGN-259 but does not contain Tβ4
Sponsors
ReGenTree, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Unanesthetized Schirmer's Test | 29 days after first dosing | Comparing each of active group & Placebo. |
| Corneal Fluorescein Staining | 8, 15, 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event Query | 1, 8, 15, 29 days | Frequencies |
| Change in Biomicroscopy Using the Undilated Fundoscopy | 1, 29 days | Change or shifts from Baseline |
| Change in Biomicroscopy Using the Slit-lamp | 1, 8, 15, 29 days | Change or shifts from Baseline |
| Visual Acuity | 1, 8, 15, 29 days | Change or shifts from Baseline |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| RGN-259 Active (0.1% RGN-259 ophthalmic solution) | 299 |
| Placebo Placebo (Placebo ophthalmic solution) | 302 |
| Total | 601 |
Baseline characteristics
| Characteristic | Placebo | Total | RGN-259 |
|---|---|---|---|
| Age, Continuous | 63.0 years STANDARD_DEVIATION 11.48 | 62.5 years STANDARD_DEVIATION 11.73 | 61.9 years STANDARD_DEVIATION 11.97 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 47 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 278 Participants | 553 Participants | 275 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 19 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 41 Participants | 77 Participants | 36 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 246 Participants | 497 Participants | 251 Participants |
| Sex: Female, Male Female | 223 Participants | 438 Participants | 215 Participants |
| Sex: Female, Male Male | 79 Participants | 163 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 299 | 0 / 302 |
| other Total, other adverse events | 19 / 299 | 21 / 302 |
| serious Total, serious adverse events | 3 / 299 | 2 / 302 |
Outcome results
Primary
Corneal Fluorescein Staining
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| RGN-259 | Corneal Fluorescein Staining | 0.07 score on a scale |
| Placebo | Corneal Fluorescein Staining | -0.01 score on a scale |
Primary
Ocular Discomfort
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| RGN-259 | Ocular Discomfort | 0.07 score on a scale |
| Placebo | Ocular Discomfort | -0.04 score on a scale |
Secondary
Corneal Fluorescein Staining
Comparing each of active group & Placebo.
Time frame: 8, 15, 29 days after first dosing
Secondary
Ocular Surface Disease Index (OSDI)©
Comparing each of active group & Placebo.
Time frame: 8, 15, 29 days after first dosing
Secondary
Tear Film Break-Up Time
Comparing each of active group & Placebo.
Time frame: 8, 15, 29 days after first dosing
Secondary
Unanesthetized Schirmer's Test
Comparing each of active group & Placebo.
Time frame: 29 days after first dosing
Other Pre-specified
Adverse Event Query
Frequencies
Time frame: 1, 8, 15, 29 days
Other Pre-specified
Change in Biomicroscopy Using the Slit-lamp
Change or shifts from Baseline
Time frame: 1, 8, 15, 29 days
Other Pre-specified
Change in Biomicroscopy Using the Undilated Fundoscopy
Change or shifts from Baseline
Time frame: 1, 29 days
Other Pre-specified
Visual Acuity
Change or shifts from Baseline
Time frame: 1, 8, 15, 29 days