Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia
- Conditions
- Presbyopia
- Interventions
- Drug: Phentolamine Opthalmic Solution 0.75%Other: PlaceboDrug: Low dose pilocarpineOther: Low dose pilocarpine vehicle
- Registration Number
- NCT05646719
- Lead Sponsor
- Ocuphire Pharma, Inc.
- Brief Summary
The objectives of this study are:
To evaluate the safety and efficacy of Nyxol alone and with adjunctive low dose pilocarpine to improve distance-corrected near visual acuity (DCNVA) in subjects with presbyopia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 333
- Males or females ≥ 40 and ≤ 64 years of age.
- BCDVA of 0.1 LogMAR (20/25 Snellen equivalent) or better in each eye in photopic conditions.
- DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse but not > 0.7 LogMAR (20/100 Snellen equivalent) in photopic conditions in each eye and binocularly.
- For subjects who depend on reading glasses or bifocals, binocular best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better.
- Photopic PD of ≥ 3 mm in either eye.
Ophthalmic (in either eye):
-
Use of any topical prescription or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of Screening until study completion, with the exception of lid scrubs with OTC products and artificial tears as specified in Exclusion # 2 below.
-
Use of any OTC artificial tears (preserved or unpreserved) during Visit days or 15 min before or after instillation of study medication.
-
Current use of any topical ophthalmic therapy for dry eye.
-
Tear break-up time of < 5 seconds or corneal fluorescein staining Grade ≥ 2 in the inferior zone or Grade ≥ 1 in the central zone using the National Eye Institute scale..
-
Clinically significant ocular disease that might interfere with the study as deemed by the Investigator.
-
Recent or current evidence of ocular infection or inflammation in either eye.
-
Any history of herpes simplex or herpes zoster keratitis.
-
Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations.
-
Prior participation in a study involving the use of Nyxol for the treatment of presbyopia.
-
History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.
-
Ocular trauma within 6 months prior to Screening.
-
Ocular surgery or any ocular laser treatment within 6 months prior to Screening.
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Subjects with surgical monovision, multifocal or extended depth of focus intraocular lenses (IOLs) are excluded.
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History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris.
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Contact lens wear on the day of any study visit and contact lenses must be removed for home dosing and for at least 10 minutes following dosing.
Systemic:
-
Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists .
-
Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agent.
-
Clinically significant systemic disease that might interfere with the study as deemed by the judgment of the Investigator.
-
Initiation of treatment with, or any changes to, the current dosage, drug, or regimen of any systemic adrenergic or cholinergic drugs within 7 days prior to Screening or during the study.
-
Participation in any investigational study within 30 days prior to Screening.
-
Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
-
Resting HR outside the range of 50 to 110 beats per min.
-
Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nyxol + low dose pilocarpine Phentolamine Opthalmic Solution 0.75% - Placebo + low dose pilocarpine Low dose pilocarpine - Nyxol + low dose pilocarpine Low dose pilocarpine - Nyxol + low dose pilocarpine vehicle Phentolamine Opthalmic Solution 0.75% - Placebo + low dose pilocarpine Placebo - Placebo + low dose pilocarpine vehicle Placebo - Nyxol + low dose pilocarpine vehicle Low dose pilocarpine vehicle - Placebo + low dose pilocarpine vehicle Low dose pilocarpine vehicle -
- Primary Outcome Measures
Name Time Method Percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA and with < 5 letters of loss in photopic binocular BCDVA in Nyxol-treated subjects Baseline at 30 min post-LDP/vehicle comparing subjects treated with Nyxol + LDP to subjects treated with placebo + LDP vehicle at Visit 5 (Stage 2 Day 8) The primary efficacy endpoint is the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA and with \< 5 letters of loss in photopic binocular BCDVA from Baseline at 30 min post-LDP/vehicle comparing subjects treated with Nyxol + LDP to subjects treated with placebo + LDP vehicle at Visit 5 (Stage 2 Day 8).
- Secondary Outcome Measures
Name Time Method Percent of subjects with ≥ 15 letters improvement in photopic binocular DCNVA and with < 5 letters of loss in photopic binocular BCDVA in LDP+Nyxol-treated subjects At 30 min post-LDP/vehicle comparing Nyxol + LDP to Nyxol alone at Visit 5 (Stage 2 Day 8) The percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA and with \< 5 letters of loss in photopic binocular BCDVA at 30 min post-LDP/vehicle comparing Nyxol + LDP to Nyxol alone at Visit 5 (Stage 2 Day 8).
Percentage of subjects with ≥ 15 letters of improvement in binocular photopic DCNVA and with < 5 letters of loss in binocular photopic BCDVA from Baseline (excluding primary and key secondary outcome timepoints) At various timepoints and visits by treatment arms in Stage 1 and Stage 2 Percentage of subjects with ≥ 15 letters of improvement in binocular photopic DCNVA and with \< 5 letters of loss in binocular photopic BCDVA from Baseline (excluding primary and key secondary outcome timepoints)
Percentage of subjects with ≥ 5, ≥ 10, and ≥ 15 letters of improvement in photopic DCNVA from Baseline (monocular and binocular) At various timepoints and visits by treatment arms in Stage 1 and Stage 2 Percentage of subjects with ≥ 5, ≥ 10, and ≥ 15 letters of improvement in photopic DCNVA from Baseline (monocular and binocular)
Change in photopic and mesopic BCDVA from Baseline (monocular and binocular) At various timepoints and visits by treatment arms in Stage 1 and Stage 2 Change in photopic and mesopic BCDVA from Baseline (monocular and binocular)
Change in mesopic binocular DCNVA from Baseline At various timepoints and visits by treatment arms in Stage 1 and Stage 2 Change in mesopic binocular DCNVA from Baseline
Change and percent change in photopic PD from Baseline At various timepoints and visits by treatment arms in Stage 1 and Stage 2 Change and percent change in photopic PD from Baseline
Change in photopic DCNVA from Baseline (monocular and binocular) At various timepoints and visits by treatment arms in Stage 1 and Stage 2 Change in photopic DCNVA from Baseline (monocular and binocular)
Percentage of subjects with loss or improvement in photopic and mesopic BCDVA from Baseline (monocular and binocular) At various timepoints and visits by treatment arms in Stage 1 and Stage 2 Percentage of subjects with loss or improvement in photopic and mesopic BCDVA from Baseline (monocular and binocular)
Percentage of subjects with ≥ 5, ≥ 10, and ≥ 15 letters of improvement in mesopic binocular DCNVA from Baseline At various timepoints and visits by treatment arms in Stage 1 and Stage 2 Percentage of subjects with ≥ 5, ≥ 10, and ≥ 15 letters of improvement in mesopic binocular DCNVA from Baseline
Percentage of subjects with photopic PD of < 3.5, < 3.0, < 2.5, < 2.0, and < 1.5 mm At various timepoints and visits by treatment arms in Stage 1 and Stage 2 Percentage of subjects with photopic PD of \< 3.5, \< 3.0, \< 2.5, \< 2.0, and \< 1.5 mm
Percentage of subjects with photopic PD of 1.5 to < 2.0 mm, 2.0 to < 2.5 mm, 2.5 to < 3.0 mm, and 3.0 to < 3.5 mm At various timepoints and visits by treatment arms in Stage 1 and Stage 2 Percentage of subjects with photopic PD of 1.5 to \< 2.0 mm, 2.0 to \< 2.5 mm, 2.5 to \< 3.0 mm, and 3.0 to \< 3.5 mm
Change and percent change in mesopic PD from Baseline At various timepoints and visits by treatment arms in Stage 1 and Stage 2 Change and percent change in mesopic PD from Baseline
Percentage of subjects with mesopic PD of < 3.5, < 3.0, < 2.5, < 2.0, and < 1.5 mm At various timepoints and visits by treatment arms in Stage 1 and Stage 2 Percentage of subjects with mesopic PD of \< 3.5, \< 3.0, \< 2.5, \< 2.0, and \< 1.5 mm
Percentage of subjects with Baseline photopic DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160, with a ≥ 10-letter and ≥ 15-letter improvement in photopic DCNVA At various timepoints and visits by treatment arms in Stage 1 and Stage 2 Percentage of subjects with Baseline photopic DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160, with a ≥ 10-letter and ≥ 15-letter improvement in photopic DCNVA
Percentage of subjects with Baseline photopic DCNVA from 20/50 to 20/63, 20/50 to 20/80, 20/50 to 20/100, 20/50 to 20/125, and 20/50 to 20/160, with a ≥ 10-letter and ≥ 15-letter improvement in photopic DCNVA At various timepoints and visits by treatment arms in Stage 1 and Stage 2 Percentage of subjects with Baseline photopic DCNVA from 20/50 to 20/63, 20/50 to 20/80, 20/50 to 20/100, 20/50 to 20/125, and 20/50 to 20/160, with a ≥ 10-letter and ≥ 15-letter improvement in photopic DCNVA
Percentage of subjects with mesopic PD of 1.5 to < 2.0 mm, 2.0 to < 2.5 mm, 2.5 to < 3.0 mm, and 3.0 to < 3.5 mm At various timepoints and visits by treatment arms in Stage 1 and Stage 2 Percentage of subjects with mesopic PD of 1.5 to \< 2.0 mm, 2.0 to \< 2.5 mm, 2.5 to \< 3.0 mm, and 3.0 to \< 3.5 mm
Subject questionnaire responses related to change in near vision and satisfaction with near vision. At various timepoints and visits by treatment arms in Stage 1 and Stage 2 Subject questionnaire responses related to change in near vision and satisfaction with near vision.
Trial Locations
- Locations (26)
Houston, TX
🇺🇸Houston, Texas, United States
San Antonio, TX
🇺🇸San Antonio, Texas, United States
Phoenix, AZ
🇺🇸Phoenix, Arizona, United States
Kansas City, MO
🇺🇸Kansas City, Missouri, United States
Rochester, NY
🇺🇸Rochester, New York, United States
Pittsburg, KS
🇺🇸Pittsburg, Kansas, United States
Shawnee Mission, KS
🇺🇸Shawnee Mission, Kansas, United States
Saint Louis, MO
🇺🇸Saint Louis, Missouri, United States
Austin, TX
🇺🇸Austin, Texas, United States
Athens, OH
🇺🇸Athens, Ohio, United States
Chesterfield, MO
🇺🇸Chesterfield, Missouri, United States
Fargo, ND
🇺🇸Fargo, North Dakota, United States
Azusa, CA
🇺🇸Azusa, California, United States
Northridge, CA
🇺🇸Northridge, California, United States
Newport Beach, CA
🇺🇸Newport Beach, California, United States
Longwood, FL
🇺🇸Longwood, Florida, United States
Delray Beach, FL
🇺🇸Delray Beach, Florida, United States
Roswell, GA
🇺🇸Roswell, Georgia, United States
Lake Villa, IL
🇺🇸Lake Villa, Illinois, United States
Smithtown, NY
🇺🇸Smithtown, New York, United States
Bloomington, MN
🇺🇸Bloomington, Minnesota, United States
Garner, NC
🇺🇸Garner, North Carolina, United States
New Freedom, PA
🇺🇸New Freedom, Pennsylvania, United States
Cranberry Township, PA
🇺🇸Cranberry Township, Pennsylvania, United States
Sioux Falls, SD
🇺🇸Sioux Falls, South Dakota, United States
Memphis, TN
🇺🇸Memphis, Tennessee, United States
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