Dry Eye
Conditions
Brief summary
This is a Phase 2a, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and tolerability and to explore the efficacy activity of VVN001 ophthalmic solution versus vehicle in subjects with dry eye disease.
Interventions
DRUGVehicle
VVN001 Ophthalmic Solution Vehicle
DRUGVVN001 Ophthalmic Solution 1%
VVN001 Ophthalmic Solution 1%
DRUGVVN001 Ophthalmic Solution 5%
VVN001 Ophthalmic Solution 5%
Sponsors
VivaVision Biotech, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-masked
Intervention model description
Double-masked parallel
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provide written informed consent prior to any study-related procedures . * Are 18 years of age or older. * Are willing and able to follow instructions and willing to be present for the required study visits for the duration of the study. * Have a best corrected visual acuity (BCVA), using corrective lenses if necessary, in the qualifying eye(s) of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) at the screening visit and randomization visit. * Have a history of dry eye disease in both eyes * Are currently using artificial tears and have been using within 30 days of the screening visit. * Have an Eye dryness score ≥40 at Visit 1 and ≥35 at Visit 2, one score for both eyes (0-100 point VAS) * Have ongoing dry eye disease in the same eye or both eyes, as defined by all of the following criteria in the study eye and the same eye at Visit 1 and Visit 2: * Inferior CFS (iCFS) score of ≥2 (NEI; 0-4 scale; using 0.5 unit increments) * Have a Schirmer score (without anesthesia) of ≥1 and ≤7 mm/5 min.
Exclusion criteria
* Have a known hypersensitivity or contraindication to the IP or components of IP. * Have a Schirmer score (without anesthesia) of \<1 or \>7 mm/5 min in the study eye. * Have history of uncontrolled glaucoma, IOP over 21 mmHg in either eye at the screening visit or are being treated with eye drops for glaucoma in the study eye. Or the subject has had laser or surgery for glaucoma in the study eye within 90 days of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inferior Corneal Fluorescein Staining | Day 84 | Mean change from baseline in Inferior corneal fluorescein staining. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -4 to +4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Corneal Fluorescein Staining | Day 84 | Mean change from baseline in total corneal fluorescein staining Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -20 to +20. |
| Regional Corneal Fluorescein Staining | Day 84 | Mean change from baseline in temporal regional corneal fluorescein staining. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -4 to +4. |
| Eye Dryness | Day 84 | Mean Change in Eye Dryness VAS. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -100 to +100.. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VVN001, 1% VVN001, 1% ophthalmic solution
VVN001 Ophthalmic Solution 1%: VVN001 Ophthalmic Solution 1% | 57 |
| VVN001, 5% VVN001, 5% ophthalmic solution
VVN001 Ophthalmic Solution 5%: VVN001 Ophthalmic Solution 5% | 56 |
| Vehicle VVN001 Ophthalmic Solution Placebo
Vehicle: VVN001 Ophthalmic Solution Vehicle | 56 |
| Total | 169 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 2 |
| Overall Study | Physician Decision | 1 | 0 | 0 |
| Overall Study | Subject travel | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 2 |
Baseline characteristics
| Characteristic | VVN001, 1% | Total | Vehicle | VVN001, 5% |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 30 Participants | 89 Participants | 29 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 80 Participants | 27 Participants | 26 Participants |
| Age, Continuous | 65.2 years STANDARD_DEVIATION 14.5 | 63.4 years STANDARD_DEVIATION 13.18 | 62.6 years STANDARD_DEVIATION 13.25 | 62.5 years STANDARD_DEVIATION 11.68 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 42 Participants | 12 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 127 Participants | 44 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Eye Dryness Visual Analog Scale | 66.5 units on a scale STANDARD_DEVIATION 18.59 | 65.9 units on a scale STANDARD_DEVIATION 17.09 | 64.9 units on a scale STANDARD_DEVIATION 17.34 | 66.2 units on a scale STANDARD_DEVIATION 15.43 |
| Inferior Corneal Fluorescein Staining | 2.45 units on a scale (0 none to 4 severe) STANDARD_DEVIATION 0.532 | 2.44 units on a scale (0 none to 4 severe) STANDARD_DEVIATION 0.536 | 2.44 units on a scale (0 none to 4 severe) STANDARD_DEVIATION 0.548 | 2.45 units on a scale (0 none to 4 severe) STANDARD_DEVIATION 0.537 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 14 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 29 Participants | 10 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 43 Participants | 125 Participants | 41 Participants | 41 Participants |
| Regional corneal fluorescein staining | 2.45 units on a scale STANDARD_DEVIATION 0.532 | 2.44 units on a scale STANDARD_DEVIATION 0.536 | 2.44 units on a scale STANDARD_DEVIATION 0.548 | 2.45 units on a scale STANDARD_DEVIATION 0.537 |
| Sex: Female, Male Female | 39 Participants | 126 Participants | 39 Participants | 48 Participants |
| Sex: Female, Male Male | 18 Participants | 43 Participants | 17 Participants | 8 Participants |
| Total Corneal Fluorescein Staining | 6.64 units on a scale STANDARD_DEVIATION 3.24 | 6.59 units on a scale STANDARD_DEVIATION 3.04 | 6.18 units on a scale STANDARD_DEVIATION 2.92 | 6.96 units on a scale STANDARD_DEVIATION 2.97 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 56 | 0 / 56 |
| other Total, other adverse events | 3 / 56 | 6 / 57 | 2 / 56 |
| serious Total, serious adverse events | 0 / 56 | 0 / 57 | 0 / 56 |
Outcome results
Primary
Inferior Corneal Fluorescein Staining
Mean change from baseline in Inferior corneal fluorescein staining. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -4 to +4.
Time frame: Day 84
Population: Sample size reflects number of subjects evaluable at Day 84
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VVN001, 1% | Inferior Corneal Fluorescein Staining | -0.69 score on a scale | Standard Deviation 0.77 |
| VVN001, 5% | Inferior Corneal Fluorescein Staining | -.97 score on a scale | Standard Deviation 0.81 |
| Vehicle | Inferior Corneal Fluorescein Staining | -0.72 score on a scale | Standard Deviation 0.83 |
Secondary
Eye Dryness
Mean Change in Eye Dryness VAS. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -100 to +100..
Time frame: Day 84
Population: Sample size reflects number of subjects evaluable at Day 84
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VVN001, 1% | Eye Dryness | -28.7 score on a scale | Standard Deviation 27.4 |
| VVN001, 5% | Eye Dryness | -22.2 score on a scale | Standard Deviation 25.02 |
| Vehicle | Eye Dryness | -19.9 score on a scale | Standard Deviation 29 |
Secondary
Regional Corneal Fluorescein Staining
Mean change from baseline in temporal regional corneal fluorescein staining. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -4 to +4.
Time frame: Day 84
Population: Sample size reflects number of subjects evaluable at Day 84
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VVN001, 1% | Regional Corneal Fluorescein Staining | -0.20 score on a scale | Standard Deviation 0.72 |
| VVN001, 5% | Regional Corneal Fluorescein Staining | -0.52 score on a scale | Standard Deviation 0.87 |
| Vehicle | Regional Corneal Fluorescein Staining | -0.11 score on a scale | Standard Deviation 0.84 |
Secondary
Total Corneal Fluorescein Staining
Mean change from baseline in total corneal fluorescein staining Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -20 to +20.
Time frame: Day 84
Population: Sample size reflects number of subjects evaluable at Day 84
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VVN001, 1% | Total Corneal Fluorescein Staining | -1.75 score on a scale | Standard Deviation 2.39 |
| VVN001, 5% | Total Corneal Fluorescein Staining | -2.60 score on a scale | Standard Deviation 3.25 |
| Vehicle | Total Corneal Fluorescein Staining | -0.79 score on a scale | Standard Deviation 3.08 |