Aceclidine, Brimonidine Tartrate, Eye Diseases, Ophthalmic Solutions, Presbyopia, Refractive Errors
Conditions
Brief summary
This is a single-center, open-label, randomized study to assess the plasma pharmacokinetic profile of LNZ101 and LNZ100.
Detailed description
To characterize the plasma pharmacokinetics and safety profile of LNZ101 and LNZ100 ophthalmic solutions in both eyes once a day for 8 days in healthy volunteers with presbyopia
Interventions
DRUGAceclidine + Brimonidine
LNZ101 (Aceclidine/Brimonidine) non-preserved ophthalmic solution
DRUGAceclidine
LNZ100 (Aceclidine) non-preserved ophthalmic solution
Sponsors
ORA, Inc.
LENZ Therapeutics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
this is an open label study.
Intervention model description
A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Each subject must: 1. Be able and willing to provide written informed consent and sign a 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 all study visits; 3. Be 45-75 years of age of either sex and any race or ethnicity; 4. Be presbyopic in both eyes;
Exclusion criteria
* Each subject must not: 1. Have known contraindications or sensitivity to the use of the investigational drug or its components, or any other medications required by the protocol; 2. Have any active systemic or ocular disorder other than refractive disorder; 3. Have prior, current or anticipated use of any contact lenses during study participation; 4. Have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that could affect ophthalmic drop absorption; 5. Have anticipated inability to stay confined on required study days;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-t | Day 1 and Day 8 | Area under the concentration-time curve from time 0 to time t of LNZ100 and LNZ100 |
| Tmax | Day 1 and Day 8 | Time of maximum plasma concentrations of LNZ100 and LNZ101 |
| Cmax | Day 1 and Day 8 | Maximum plasma concentrations of LNZ100 and LNZ101 |
| AUC0-inf | Day 1 and Day 8 | Area under the concentration-time curve from time 0 to infinity of LNZ100 and LNZ101 |
| T1/2 | Day 1 and Day 8 | Terminal half-life of LNZ100 and LNZ101 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety: adverse event reporting | up to 37 days | The number of patients who experience one or more TEAE during the treatment period |
Countries
United States
Outcome results
None listed