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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04983589 | A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily | PHASE3 | COMPLETED | 230 | — | — | Sep 2, 2021 | Feb 11, 2022 | Mar 21, 2023 | 23 | United States |
| NCT03857542 | A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia | PHASE3 | COMPLETED | 427 | — | — | Mar 1, 2019 | Sep 10, 2020 | Dec 29, 2021 | 35 | United States |
| NCT03804268 | Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia | PHASE3 | COMPLETED | 323 | — | — | Dec 21, 2018 | Oct 31, 2019 | Dec 28, 2021 | 36 | United States |
Visual acuity for near (40 centimeter \[cm\]) and distance (4 meter \[m\]) targets were measured in mesopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with mesopic lighting conditions (10 to 11 lux) measured at the target. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who gained 3 lines or more in mesopic, high contrast, binocular DCNVA with no more than 5-letter loss in mesopic CDVA with the same refractive correction was regarded as a responder. A participant with missing data was regarded as a non-responder.
Visual acuity for near (40 centimeter (cm)) and distance (4 meter (m)) targets were measured in mesopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with mesopic lighting conditions measured at the target. Forced choice letter by-letter scoring was used for each test and the total number of correct letters or the highest value (number) of the grid identified (as applicable) were recorded. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter (cd/m\^2) measured at the target. DCNVA= distance-corrected near visual acuity.
Visual acuity for near (40 centimeters (cm)) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter (cd/m\^2) measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast DCNVA are reported.
| Arm | Type | Description |
|---|---|---|
| Vehicle | PLACEBO_COMPARATOR | Participants received vehicle, one drop bilaterally (in each eye), twice daily (BID), with a gap of 6 hours between both doses, for up to 14 days. |
| AGN-190584 | EXPERIMENTAL | AGN-190584 ophthalmic solution, one drop bilaterally (in each eye), BID, with a gap of 6 hours between both doses, for up to 14 days. |
| Pilocarpine HCl Ophthalmic Solution | EXPERIMENTAL | Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days. |
| Name | Type | Description |
|---|---|---|
| Pilocarpine HCl | DRUG | Pilocarpine HCl ophthalmic solution 1.25% ocular drops. |
| Vehicle | DRUG | Oxymetazoline HCl and pilocarpine HCl placebo ocular drops. |
| Pilocarpine HCl Ophthalmic Solution | DRUG | Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days. |
Inclusion Criteria: \- Objective and subjective evidence of presbyopia. Exclusion Criteria: * Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity. * Narrow iridocorneal angles (S...