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NCT05114486 · ClinicalTrials.gov registry record · Phase 3
Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults
A Phase 3 study of Presbyopia, sponsored by Eyenovia.
- Completed
- Registry status
- Phase 3
- Development phase
- 145
- Enrollment target
- 9
- Study locations
NCT05114486: Completed Phase 3 study of Presbyopia, sponsored by Eyenovia.
NCT05114486 is a Phase 3 study of Presbyopia that has completed, run by Eyenovia. The registered enrollment target is 145 participants, below the 267-participant average among 38 other Presbyopia trials with a reported enrollment target (46% lower). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05114486, a Phase 3 study of Presbyopia, has completed, sponsored by Eyenovia.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 145 participants
- Enrollment target
- 9
- Study locations
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.
Primary Outcome
The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA with ≤ 5 letter loss DVA as compared to baseline.
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
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2021-11-03 |
| Est. Completion | 2022-09-20 |
| Phase | Phase 3 |
What the finished NCT05114486 record still lists
NCT05114486 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 267-participant average among 38 other Presbyopia trials with a reported enrollment target (46% lower).
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.
NCT05114486 lists 9 locations in 9 states (California, Connecticut, Kentucky).
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.
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).
Who is sponsoring clinical trial NCT05114486?
This trial is sponsored by Eyenovia, which has 7 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Presbyopia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05114486's enrollment target sits among peer trials
145 12th of 38 higher than 27 of 38 other Presbyopia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Presbyopia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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