Decrease in Night Vision, Disturbance; Vision, Loss
Conditions
Keywords
Night Vision Disturbances, NVD, Glare, Halos, Starbursts, Nyxol
Brief summary
The objectives of this study are: * To assess the effect of ophthalmic phentolamine mesylate in mesopic conditions on the four endpoints: 1. Contrast sensitivity 2. Low contrast visual acuity 3. Wavefront aberrometry 4. Subjective questionnaire * To assess the safety of ophthalmic phentolamine mesylate
Detailed description
Double-masked, placebo-controlled, single-dose Phase 2 study in 24 patients experiencing severe night vision difficulties to evaluate ocular and systemic safety and efficacy following administration of one drop of phentolamine mesylate 1.0% QD in each eye for 1 day.
Interventions
Topical Sterile Ophthalmic Solution
Topical Sterile Ophthalmic Solution
Sponsors
Ophthalmic Consultants of Long Island
Ocuphire Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patients ≥ 18 years of age 2. Currently experiencing severe night vision difficulty as reported subjectively 3. At least two patches below the normal range at any two frequencies in Contrast Sensitivity done under mesopic conditions with glare 4. Improvement in low contrast visual acuity (LCVA) in dim light during illumination of contralateral eye 5. Good general health 6. Written informed consent to participate in this trial 7. Ability to comply with all protocol mandated procedures and to attend all scheduled office visits
Exclusion criteria
1. Patients with untreated cataracts grades 1-4 2. Patients who wear contact lenses 3. Less than 5 weeks post-refractive surgery (LASIK or PRK) 4. Less than 5 weeks post intraocular lens insertion 5. Low blood pressure (systolic \<120 mm Hg or diastolic \<80 mm Hg) 6. A history of heart rate abnormalities 7. Administration of any investigational drug within 30 days of study initiation 8. Use of any eye drops with a pharmacologic effect on the pupil within 7 days of Visit 1 9. Use of any systemic alpha adrenergic antagonists (Appendix 1) 10. Known local or systemic hypersensitivity to adrenergic antagonists 11. For women of childbearing potential: currently pregnant or lactating, or unwilling to use birth control during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contrast Sensitivity | 1 day | Average change in monocular contrast sensitivity scores under mesopic conditions at each of five spatial frequencies with and without glare. The tests were performed in a darkened room using the Optec 6500 instrument (Stereo Optical) using Slides 5-9 (spatial frequencies 1.5 - 18 cycles per degree), with the distance setting at far, and with the light setting at night. Subjects were asked to read each slide from left to right indicating if the lines were tilted to the left, the right or straight up and down until they provided 2 consecutive incorrect responses. The total number of correct responses for each slide was recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 1 day | Average number of letters of improvement in the following parameters: 1. Distance high-contrast visual acuity under mesopic conditions (monocular, measured at 4 meters) 2. Distance high-contrast visual acuity under photopic conditions (monocular, measured at 4 meters) 3. Distance low-contrast visual acuity under mesopic conditions (monocular, measured at 4 meters) 4. Distance low-contrast visual acuity under photopic conditions (monocular, measured at 4 meters) |
| Self-Reported Vision Quality | 1 day | Subjective patient evaluations of vision quality at night (% rating their vision as improved) |
| Pupil Diameter | 1 day | Average change in pupil diameter |
Countries
United States
Participant flow
Recruitment details
24 subjects were enrolled. Both eyes were treated and evaluated for efficay and safety.
Participants by arm
| Arm | Count |
|---|---|
| Phentolamine Mesylate Ophthalmic Solution 1% 1 drop in each eye (QD) for one day.
Phentolamine Mesylate Ophthalmic Solution 1%: Topical Sterile Ophthalmic Solution | 16 |
| Phentolamine Mesylate Ophthalmic Solution 1% 1 drop in each eye (QD) for one day.
Phentolamine Mesylate Ophthalmic Solution 1%: Topical Sterile Ophthalmic Solution | 32 |
| Phentolamine Mesylate Ophthalmic Solution Vehicle 1 drop in each eye (QD) for one day.
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution | 8 |
| Phentolamine Mesylate Ophthalmic Solution Vehicle 1 drop in each eye (QD) for one day.
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution | 16 |
| Total | 72 |
Baseline characteristics
| Characteristic | Total | Phentolamine Mesylate Ophthalmic Solution 1% | Phentolamine Mesylate Ophthalmic Solution Vehicle |
|---|---|---|---|
| Age, Continuous | 43.9 years STANDARD_DEVIATION 19.9 | 42.1 years STANDARD_DEVIATION 14.6 | 47.4 years STANDARD_DEVIATION 13.5 |
| Pupil Diameter Illuminated | 4.6 mm STANDARD_DEVIATION 1 | 4.4 mm STANDARD_DEVIATION 0.6 | 4.9 mm STANDARD_DEVIATION 0.8 |
| Sex: Female, Male Female | 17 Participants | 12 Participants | 5 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 3 Participants |
| Trans-Illuminated Low Contrast Visual Acuity | 32.1 Letters STANDARD_DEVIATION 10 | 33.1 Letters STANDARD_DEVIATION 5.4 | 30.1 Letters STANDARD_DEVIATION 8.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 8 |
| serious Total, serious adverse events | 0 / 16 | 0 / 8 |
Outcome results
Primary
Contrast Sensitivity
Average change in monocular contrast sensitivity scores under mesopic conditions at each of five spatial frequencies with and without glare. The tests were performed in a darkened room using the Optec 6500 instrument (Stereo Optical) using Slides 5-9 (spatial frequencies 1.5 - 18 cycles per degree), with the distance setting at far, and with the light setting at night. Subjects were asked to read each slide from left to right indicating if the lines were tilted to the left, the right or straight up and down until they provided 2 consecutive incorrect responses. The total number of correct responses for each slide was recorded.
Time frame: 1 day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phentolamine Mesylate Ophthalmic Solution 1% | Contrast Sensitivity | 12 Cycles without Glare | 0.8 Patches | Standard Deviation 1.6 |
| Phentolamine Mesylate Ophthalmic Solution 1% | Contrast Sensitivity | 1.5 Cycles with Glare | 0.6 Patches | Standard Deviation 1.8 |
| Phentolamine Mesylate Ophthalmic Solution 1% | Contrast Sensitivity | 3 Cycles with Glare | 0.9 Patches | Standard Deviation 2.1 |
| Phentolamine Mesylate Ophthalmic Solution 1% | Contrast Sensitivity | 6 Cycles with Glare | 1.4 Patches | Standard Deviation 1.9 |
| Phentolamine Mesylate Ophthalmic Solution 1% | Contrast Sensitivity | 12 Cycles with Glare | 1.7 Patches | Standard Deviation 2 |
| Phentolamine Mesylate Ophthalmic Solution 1% | Contrast Sensitivity | 18 Cycles with Glare | 1.3 Patches | Standard Deviation 1.8 |
| Phentolamine Mesylate Ophthalmic Solution 1% | Contrast Sensitivity | 1.5 Cycles without Glare | 1.0 Patches | Standard Deviation 1.4 |
| Phentolamine Mesylate Ophthalmic Solution 1% | Contrast Sensitivity | 3 Cycles without Glare | 1.3 Patches | Standard Deviation 1.5 |
| Phentolamine Mesylate Ophthalmic Solution 1% | Contrast Sensitivity | 6 Cycles without Glare | 1.1 Patches | Standard Deviation 1.4 |
| Phentolamine Mesylate Ophthalmic Solution 1% | Contrast Sensitivity | 18 Cycles without Glare | 0.5 Patches | Standard Deviation 1.4 |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Contrast Sensitivity | 12 Cycles with Glare | 0.4 Patches | Standard Deviation 1 |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Contrast Sensitivity | 18 Cycles without Glare | 0.3 Patches | Standard Deviation 0.9 |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Contrast Sensitivity | 3 Cycles without Glare | 0.7 Patches | Standard Deviation 1.3 |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Contrast Sensitivity | 6 Cycles without Glare | 0.5 Patches | Standard Deviation 1.4 |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Contrast Sensitivity | 1.5 Cycles with Glare | 0.8 Patches | Standard Deviation 1.5 |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Contrast Sensitivity | 18 Cycles with Glare | 0.3 Patches | Standard Deviation 0.8 |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Contrast Sensitivity | 3 Cycles with Glare | 0.7 Patches | Standard Deviation 1.5 |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Contrast Sensitivity | 12 Cycles without Glare | -0.2 Patches | Standard Deviation 1 |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Contrast Sensitivity | 6 Cycles with Glare | 0.1 Patches | Standard Deviation 1.3 |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Contrast Sensitivity | 1.5 Cycles without Glare | 0.4 Patches | Standard Deviation 1.4 |
Secondary
Pupil Diameter
Average change in pupil diameter
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phentolamine Mesylate Ophthalmic Solution 1% | Pupil Diameter | -1.3 mm | Standard Deviation 0.8 |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Pupil Diameter | -0.2 mm | Standard Deviation 0.5 |
Secondary
Self-Reported Vision Quality
Subjective patient evaluations of vision quality at night (% rating their vision as improved)
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phentolamine Mesylate Ophthalmic Solution 1% | Self-Reported Vision Quality | 69 Percentage |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Self-Reported Vision Quality | 75 Percentage |
Secondary
Visual Acuity
Average number of letters of improvement in the following parameters: 1. Distance high-contrast visual acuity under mesopic conditions (monocular, measured at 4 meters) 2. Distance high-contrast visual acuity under photopic conditions (monocular, measured at 4 meters) 3. Distance low-contrast visual acuity under mesopic conditions (monocular, measured at 4 meters) 4. Distance low-contrast visual acuity under photopic conditions (monocular, measured at 4 meters)
Time frame: 1 day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phentolamine Mesylate Ophthalmic Solution 1% | Visual Acuity | Distance high-contrast visual acuity under mesopic conditions | 6.5 Letters | Standard Deviation 7.2 |
| Phentolamine Mesylate Ophthalmic Solution 1% | Visual Acuity | Distance high-contrast visual acuity under photopic conditions | 3.8 Letters | Standard Deviation 7.6 |
| Phentolamine Mesylate Ophthalmic Solution 1% | Visual Acuity | Distance low-contrast visual acuity under mesopic conditions | 8.0 Letters | Standard Deviation 8.4 |
| Phentolamine Mesylate Ophthalmic Solution 1% | Visual Acuity | Distance low-contrast visual acuity under photopic conditions | 7.3 Letters | Standard Deviation 6.6 |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Visual Acuity | Distance low-contrast visual acuity under photopic conditions | 0.9 Letters | Standard Deviation 3.6 |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Visual Acuity | Distance high-contrast visual acuity under mesopic conditions | 1.1 Letters | Standard Deviation 3.9 |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Visual Acuity | Distance low-contrast visual acuity under mesopic conditions | 3.1 Letters | Standard Deviation 4.5 |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Visual Acuity | Distance high-contrast visual acuity under photopic conditions | 0.1 Letters | Standard Deviation 3.8 |