The objectives of this study are: To evaluate the efficacy of Nyxol + Pilocarpine to improve DCNVA in subjects with presbyopia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Pilocarpine ophthalmic solution
Topical sterile ophthalmic solution
Clinical Site 12
Laguna Hills, California, United States
Clinical Site 6
Newport Beach, California, United States
Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA
The primary efficacy endpoint was the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA on Visit 2 at 1 hour with POS + LDP compared to placebo alone. The improvement in binocular DCNVA for each subject was relative to the subject's own baseline value (Visit 1).
Time frame: Visit 2 at 1 hour
Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline
The percentage of subjects with improvement of ≥ 5, ≥ 10, and ≥ 15 letters in DCNVA (photopic) from Baseline at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours
Time frame: Visit 2 at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours
Percentage of Subjects With Improvement of ≥ 15 Letters in DCNVA (Photopic) at 1 Hour and With < 5 Letters of Loss in Photopic Binocular BCDVA From Baseline
The percentage of subjects with improvement of ≥ 15 letters in DCNVA (photopic) at 1 hour and with \< 5 letters of loss in photopic binocular BCDVA from Baseline
Time frame: Visit 2 at 1 hour
Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline
The percentage of subjects with improvement in DCIVA (photopic) from Baseline of ≥ 5, ≥ 10, and ≥ 15 letters
Time frame: Visit 2 at 1 hour, at 3 hours, and at 6 hours
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Clinical Site 13
Crystal River, Florida, United States
Clinical Site 5
Longwood, Florida, United States
Clinical Site 11
Maitland, Florida, United States
Clinical Site 8
Sarasota, Florida, United States
Clinical Site 10
Roswell, Georgia, United States
Clinical Site 3
Pittsburg, Kansas, United States
Clinical Site 18
St Louis, Missouri, United States
Clinical Site 16
Poughkeepsie, New York, United States
...and 7 more locations