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COMPLETED Phase 3

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

NCT05114486 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • COMBINATION_PRODUCT Pilocarpine Ophthalmic administered with the Optejet dispenser
  • COMBINATION_PRODUCT Placebo administered with the Optejet dispenser

Study Locations (9)

California

  • VISION-2 Study Site #57 — San Diego

Connecticut

  • VISION-2 Study Site #59 — Fairfield

Kentucky

  • VISION-2 Study Site #56 — Louisville

Ohio

  • VISION-2 Study Site #19 — Columbus

Pennsylvania

  • VISION-2 Study Site #58 — Philadelphia

South Dakota

  • VISION-2 Study Site #62 — Sioux Falls

Tennessee

  • VISION-2 Study Site #55 — Memphis

Texas

  • VISON-2 Study Site #60 — Austin

Trial Details

FieldValue
Enrollment Target 145 participants
Start Date 2021-11-03
Est. Completion 2022-09-20
Phase Phase 3

Sponsor

Eyenovia

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05114486

The ClinicalTrials.gov registry entry for NCT05114486 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eyenovia, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Presbyopia appearing as the primary indexed condition, and to 2 interventions — of which Pilocarpine Ophthalmic administered with the Optejet dispenser is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05114486 reports 9 study locations spanning 9 distinct geographic areas — top geographies include California, Connecticut, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05114486 about?

NCT05114486 is a clinical study titled "Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults". 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 ar...

What is the current status of trial NCT05114486?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 145 participants. The study started on 2021-11-03. Estimated completion is 2022-09-20.

What conditions does trial NCT05114486 study?

This clinical trial studies the following conditions: Presbyopia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05114486?

The interventions under investigation include: Pilocarpine Ophthalmic administered with the Optejet dispenser (COMBINATION_PRODUCT), Placebo administered with the Optejet dispenser (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05114486?

This trial is sponsored by Eyenovia, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05114486 being conducted?

This trial has 9 study locations across California, Connecticut, Kentucky, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial