Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03809611 | A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia. | PHASE2 | COMPLETED | 125 | — | — | Apr 26, 2019 | Dec 16, 2019 | May 11, 2022 | 14 | United States |
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 ETDRS letter scores represent good vision; Low monocular DCNVA ETDRS letter scores represent poor vision.
| Arm | Type | Description |
|---|---|---|
| UNR844-Cl Ophthalmic Solution | EXPERIMENTAL | 1.5% UNR844-Cl ophthalmic solution for twice-daily dosing |
| Placebo Ophthalmic Solution | PLACEBO_COMPARATOR | placebo ophthalmic solution for twice-daily dosing |
| Name | Type | Description |
|---|---|---|
| UNR844-Cl | DRUG | 1.5% Ophthalmic solution for topical ocular administration |
| Placebo | DRUG | placebo |
Inclusion Criteria: * Written informed consent must be obtained before any assessment is performed * Impaired near vision in each eye and when using both eyes, without any near correction * Need a certain level of near correction Exclusion Criteria: * Impaired distance vision in either eye, with ...