Presbyopia
Conditions
Brief summary
Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting study inclusion/exclusion criteria are scheduled for 2 treatment visits. At each treatment visit, 1 of the 2 study treatments is self-administered to both eyes. Afterwards, efficacy and safety assessments are performed over a 3-hour period.
Interventions
COMBINATION_PRODUCTPilocarpine Ophthalmic administered with the Optejet dispenser
Pilocarpine 2% ophthalmic spray administered with the Optejet dispenser
COMBINATION_PRODUCTPlacebo administered with the Optejet dispenser
Vehicle ophthalmic solution administered with the Optejet dispenser
Sponsors
Eyenovia Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Primary Inclusion Criteria: * Poor near vision impacting daily living that requires near correction * Best-corrected distance visual acuity (BCDVA) of 0.0 logMar or better * Manifest refraction spherical equivalent ≥ -2.00 Diopters (D) and ≤ +2.00 D * Monocular DCNVA between 0.4 and 0.7 logMAR, inclusive * In need of near addition power \< +2.00 D to achieve BCNVA of 0.0 logMAR Primary
Exclusion criteria
* Diagnosis of glaucoma or ocular hypertension * Narrow iridocorneal angles * History of intraocular surgery, refractive surgery, laser treatment, or iris surgery * Clinically significant abnormality of cornea, lens, retina, ciliary body, or iris * Presence/history of a severe/serious ocular condition or any other unstable medical condition * Presence or history of manifest strabismus, amblyopia, or nystagmus * Current active eye disease for which topical or systemic ophthalmic medication is necessary, except for dry eye syndrome managed using artificial tears * Clinically significant external ocular inflammation within 30 days of Screening Visit * Current use or history of rigid gas permeable (RGP) contact lens use within 30 days of Screening Visit * Known pilocarpine allergy or contraindication to use of pilocarpine * Presence or history of congenital heart anomaly, valve disease, or other cardiac disease * Disabling arthritis or limited motor coordination that would limit the subject's ability to self-administer study solution using the Optejet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA) with ≤ 5 letter loss in mesopic, high contrast, binocular distance visual acuity (DVA) | 120 minutes post-dosing | The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA with ≤ 5 letter loss DVA as compared to baseline. |
Countries
United States
Outcome results
None listed