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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 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.
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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 267-participant average among 38 other Presbyopia trials with a reported enrollment target (46% lower). The listed sponsor is Eyenovia, which has 7 total studies on file at ClinicalTrials.gov.
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 reports 9 study locations spanning 9 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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