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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03201562 | A Single-Center, Double-Masked Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia | PHASE2 | COMPLETED | 58 | — | — | Apr 30, 2017 | May 20, 2018 | Sep 22, 2022 | 1 | United States |
Proportion of subjects with at least a 3 line (15 letter) improvement in near visual acuity in the study eye at 1 hour post-treatment in the mITT population
| Arm | Type | Description |
|---|---|---|
| Aceclidine+tropicamide combination | EXPERIMENTAL | Aceclidine+tropicamide combination single dose (PRX-100 Ophthalmic Solution) |
| Aceclidine | ACTIVE_COMPARATOR | Aceclidine single dose |
| Vehicle | SHAM_COMPARATOR | Vehicle single dose |
| Name | Type | Description |
|---|---|---|
| Aceclidine+tropicamide combination | DRUG | Ophthalmic Solution |
| Aceclidine | DRUG | Ophthalmic Solution |
| Vehicle | DRUG | Ophthalmic Solution |
Inclusion Criteria: 1. Be able and willing to provide written informed consent and sign Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed; 2. Be able and willing to follow all instructions and attend study visits; 3. Be 48-64 years of ag...