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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06270030 | Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Chinese With Presbyopia | PHASE1 | COMPLETED | 21 | — | — | Mar 4, 2024 | Apr 10, 2024 | Apr 23, 2024 | 1 | China |
Maximum plasma concentrations of LNZ100 and LNZ101
Time of maximum plasma concentrations of LNZ100 and LNZ101
Area under the concentration-time curve from time 0 to time t of LNZ100 and LNZ100
Area under the concentration-time curve from time 0 to infinity of LNZ100 and LNZ101
Terminal half-life of LNZ100 and LNZ101
The number of patients who experience one or more AE during the treatment period
| Arm | Type | Description |
|---|---|---|
| LNZ101 (Aceclidine /Brimonidine) ophthalmic solution | EXPERIMENTAL | Drug: Aceclidine/Brimonidine ophthalmic solution Other Names: LNZ101 |
| LNZ100 (Aceclidine) ophthalmic solution | EXPERIMENTAL | Drug: Aceclidine ophthalmic solution Other Names: LNZ100 |
| Placebo (Vehicle) ophthalmic solution | PLACEBO_COMPARATOR | Drug: Placebo (Vehicle) ophthalmic solution Other Names: NA |
| Name | Type | Description |
|---|---|---|
| LNZ101 (Aceclidine /Brimonidine) ophthalmic solution | DRUG | Once daily from day 1 to day 8; Everyday, subject will be administered with 1 drop in each eye followed by another drop in each eye 2 minutes later |
| LNZ100 (Aceclidine) ophthalmic solution | DRUG | Once daily from day 1 to day 8; Everyday, subject will be administered with 1 drop in each eye followed by another drop in each eye 2 minutes later |
| Placebo (Vehicle) ophthalmic solution | DRUG | Once daily from day 1 to day 8; Everyday, subject will be administered with 1 drop in each eye followed by another drop in each eye 2 minutes later |
Inclusion Criteria 1. Be able and willing to provide written informed consent prior to any study procedure being performed. 2. Be able to and willing to use investigational products per study requirements and attend all study assessments, including admission to and stay in the CRU on required study...