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Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults (VISION-2)

E

Eyenovia

Status and phase

Completed
Phase 3

Conditions

Presbyopia

Treatments

Combination Product: Placebo administered with the Optejet dispenser
Combination Product: Pilocarpine Ophthalmic administered with the Optejet dispenser

Study type

Interventional

Funder types

Industry

Identifiers

NCT05114486
EYN-PRS-PI-32

Details and patient eligibility

About

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.

Enrollment

145 patients

Sex

All

Ages

40 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

145 participants in 2 patient groups, including a placebo group

Pilocarpine 2% Ophthalmic Spray
Experimental group
Description:
2% pilocarpine ophthalmic spray administered with the Optejet dispenser
Treatment:
Combination Product: Pilocarpine Ophthalmic administered with the Optejet dispenser
Placebo Spray
Placebo Comparator group
Description:
Placebo ophthalmic spray administered with the Optejet dispenser
Treatment:
Combination Product: Placebo administered with the Optejet dispenser

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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