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NCT03809611 · ClinicalTrials.gov registry record · Phase 2
A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia.
A Phase 2 study of Presbyopia, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 125
- Enrollment target
- 14
- Study locations
NCT03809611: Completed Phase 2 study of Presbyopia, sponsored by Novartis Pharmaceuticals.
NCT03809611 is a Phase 2 study of Presbyopia that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 125 participants, below the 267-participant average among 38 other Presbyopia trials with a reported enrollment target (53% lower). The trial reports 14 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03809611, a Phase 2 study of Presbyopia, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 125 participants
- Enrollment target
- 14
- Study locations
Study Summary
The purpose of this study was to assess the effect of topical UNR844-Cl (lipoic acid choline ester chloride) ophthalmic solution on near visual function in presbyopic subjects.
Primary Outcome
Change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or placebo treatment. Low contrast (10% contrast) DCNVA at 40 cm is measured binocularly using an electronic visual acuity testing system. This assessment was performed with subjects corrected for any distance refractive errors. The system provided distance-corrected low contrast near visual acuity in an Early Treatment Diabetic Retinopathy Study (ETDRS) letter numerical score. High monocular DCNVA
Conditions Studied
Interventions
- DRUG Placebo
- DRUG UNR844-Cl
Study Locations (14)
Pennsylvania
- Novartis Investigative Site - Allenwood
- Novartis Investigative Site - Cranberry Township
- Novartis Investigative Site - Kingston
Tennessee
- Novartis Investigative Site - Memphis
- Novartis Investigative Site - Nashville
- Novartis Investigative Site - Nashville
California
- Novartis Investigative Site - Mission Hills
- Novartis Investigative Site - Newport Beach
Florida
- Novartis Investigative Site - Largo
- Novartis Investigative Site - Mt. Dora
Texas
- Novartis Investigative Site - Cedar Park
- Novartis Investigative Site - Houston
Missouri
- Novartis Investigative Site - Washington
Virginia
- Novartis Investigative Site - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2019-04-26 |
| Est. Completion | 2019-12-16 |
| Phase | Phase 2 |
What the finished NCT03809611 record still lists
NCT03809611 is an interventional study that assigns participants to a tested intervention. The registered 125 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 (53% lower).
The record links to 1 condition, with Presbyopia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03809611 lists 14 locations in 7 states (Pennsylvania, Tennessee, California).
Frequently Asked Questions
What is clinical trial NCT03809611 about?
NCT03809611 is a clinical study titled "A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia.". The purpose of this study was to assess the effect of topical UNR844-Cl (lipoic acid choline ester chloride) ophthalmic solution on near visual function in presbyopic subjects.
What is the current status of trial NCT03809611?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2019-04-26. Estimated completion is 2019-12-16.
What conditions does trial NCT03809611 study?
This clinical trial studies the following conditions: Presbyopia.
What interventions are being tested in trial NCT03809611?
The interventions under investigation include: Placebo (DRUG), UNR844-Cl (DRUG).
Who is sponsoring clinical trial NCT03809611?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03809611 being conducted?
This trial has 14 study locations across California, Florida, Missouri, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03809611's enrollment target sits among peer trials
125 13th of 38 higher than 26 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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