This is a Multicenter, Randomized, Double-Masked Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Presbyopia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
123
Pilocarpine Ophthalmic Topical Cream, Dose 1
Pilocarpine Ophthalmic Topical Cream, Dose 2
Pilocarpine Ophthalmic Topical Cream, Dose 3
Glaukos Investigator
Chandler, Arizona, United States
Glaukos Investigator
Sun City, Arizona, United States
Glaukos Investigator
Glendale, California, United States
Glaukos Investigator
Binocular Distance Corrected Near Visual Acuity (DCNVA)
Proportion of treatment responders \[subjects gaining 3 lines or more in binocular distance corrected near visual acuity (DCNVA) and not losing more than 5 letters of binocular best corrected distance visual acuity (BCDVA)\] 1 hour post-dose at the Day 28 visit.
Time frame: Day 28
Proportion of treatment responders (as defined for the primary endpoint) at 0.5, 2, 4, and 6 hours post-dose at the day 28 visit.
Proportion of treatment responders (as defined for the primary endpoint) at 0.5, 2, 4, and 6 hours post-dose at the day 28 visit.
Time frame: Day 28
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Placebo Ophthalmic Topical Cream
Newport Beach, California, United States
Glaukos Investigator
Petaluma, California, United States
Glaukos Investigator
Louisville, Kentucky, United States
Glaukos Investigator
Rochester, New York, United States
Glaukos Investigator
Memphis, Tennessee, United States
Glaukos Investigator
Houston, Texas, United States
Glaukos Investigator
San Antonio, Texas, United States