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Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults

NCT05114486 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2023-09-11

No results posted yet for this study

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.

Conditions

Interventions

COMBINATION_PRODUCT

Pilocarpine Ophthalmic administered with the Optejet dispenser

Pilocarpine 2% ophthalmic spray administered with the Optejet dispenser

COMBINATION_PRODUCT

Placebo administered with the Optejet dispenser

Vehicle ophthalmic solution administered with the Optejet dispenser

Sponsors & Collaborators

  • Eyenovia Inc.

    lead INDUSTRY

Principal Investigators

  • Tsontcho (Sean) Ianchulev, MD, MPH · Eyenovia Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-03
Primary Completion
2022-09-20
Completion
2022-09-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05114486 on ClinicalTrials.gov