Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine… (NCT05646719) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia
United States333 participantsStarted 2022-12-22
Plain-language 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.
Who can participate
Age range40 Years – 64 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
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
Timeframe: 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)