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NCT04405245 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Efficacy, Safety and Tolerability of AKB-9778 Ophthalmic Solution as and Adjunct to Latanoprost in Patients With Ocular Hypertension or Open Angle Glaucoma
A Phase 2 study of Ocular Hypertension and Primary Open Angle Glaucoma, sponsored by EyePoint Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 194
- Enrollment target
- 20
- Study locations
NCT04405245: Completed Phase 2 study of Ocular Hypertension and Primary Open Angle Glaucoma, sponsored by EyePoint Pharmaceuticals.
NCT04405245 is a Phase 2 study of Ocular Hypertension and Primary Open Angle Glaucoma that has completed, run by EyePoint Pharmaceuticals. The registered enrollment target is 194 participants, below the 275-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04405245, a Phase 2 study of Ocular Hypertension and Primary Open Angle Glaucoma, has completed, sponsored by EyePoint Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 194 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a phase 2, double masked, randomized, multi-center, parallel-group, 28-day study assessing the safety, tolerability and ocular hypotensive efficacy of AKB-9778 Ophthalmic Solution 4.0% administered once (AM) or twice (AM \& PM) daily when used as an adjunctive therapy to latanoprost ophthalmic solution 0.005% once daily (PM) in subjects with elevated IOP due to OAG or OHT.
Primary Outcome
Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Latanoprost ophthalmic solution
- DRUG AKB-9778 4%
Study Locations (20)
California
- United Medical Research Institute - Inglewood
- North Valley Eye Medical Group - Mission Hills
- Eye Research Foundation - Newport Beach
- North Bay Eye Associates - Petaluma
Georgia
- Clayton Eye Clinical Research, LLC - Morrow
- Coastal Research Associates - Roswell
Kansas
- Kannarr Eye Care - Pittsburg
- Heart of America Eye Care, P.A. - Shawnee Mission
North Carolina
- Charlotte Eye, Ear, Nose & Throat Assoc. (CEENTA) - Charlotte
- James D. Branch, MD Ophthalmology - Winston-Salem
Ohio
- Apex Eye - Cincinnati
- Abrams Eye Center - Cleveland
Pennsylvania
- Scott & Christie and Assoc - Cranberry Township
- Eye Care Specialists - Kingston
Tennessee
- Total Eye Care - Memphis
- Advancing Vision Research - Nashville
Florida
- Shettle Eye Research - Largo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2020-06-06 |
| Est. Completion | 2020-11-05 |
| Phase | Phase 2 |
What the finished NCT04405245 record still lists
NCT04405245 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, below the 275-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (29% lower).
The record links to 2 conditions, with Ocular Hypertension appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04405245 names 20 study sites across 11 states, led by California, Georgia, Kansas.
Frequently Asked Questions
What is clinical trial NCT04405245 about?
NCT04405245 is a clinical study titled "Study to Assess the Efficacy, Safety and Tolerability of AKB-9778 Ophthalmic Solution as and Adjunct to Latanoprost in Patients With Ocular Hypertension or Open Angle Glaucoma". This is a phase 2, double masked, randomized, multi-center, parallel-group, 28-day study assessing the safety, tolerability and ocular hypotensive efficacy of AKB-9778 Ophthalmic Solution 4.0% administered once (AM) or twice (AM \& PM) daily when used as an adjunctive therapy to latanoprost ophthalm...
What is the current status of trial NCT04405245?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 194 participants. The study started on 2020-06-06. Estimated completion is 2020-11-05.
What conditions does trial NCT04405245 study?
This clinical trial studies the following conditions: Ocular Hypertension, Primary Open Angle Glaucoma.
What interventions are being tested in trial NCT04405245?
The interventions under investigation include: Placebo (DRUG), Latanoprost ophthalmic solution (DRUG), AKB-9778 4% (DRUG).
Who is sponsoring clinical trial NCT04405245?
This trial is sponsored by EyePoint Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04405245 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Kansas, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04405245's enrollment target sits among peer trials
194 24th of 54 higher than 31 of 54 other Ocular Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ocular Hypertension 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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