Presbyopia, Near Vision, Miosis, Eye Diseases
Conditions
Keywords
Pharmaceutical Solutions, Opthalmic Solutions, Eye Drops, CLARITY, Presbyopia, Miotic
Brief summary
Safety Study of the Long-Term Safety of LNZ101 in Presbyopic Subjects
Detailed description
Safety Study: Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects
Interventions
Combination ophthalmic solution of Aceclidine and Brimonidine
DRUGPlacebo
Placebo: Proprietary Vehicle Solution
Aceclidine
Sponsors
ORA, Inc.
LENZ Therapeutics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-masked treatment will be used to reduce potential of bias during data collection and the evaluation of clinical endpoints.
Intervention model description
A Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
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 at Visit 1; 4. Be presbyopic in both eyes as determined by manifest refraction documented at Visit 1; 5. Have +1.00 to -4.00 diopter(D) of sphere calculated in minus cylinder (up to 2.00D of cylinder) in both eyes determined by manifest refraction documented at Visit 1
Exclusion criteria
1. Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy; 2. Have known contraindications or sensitivity to the use of any of the study medications or their components; 3. Have an active ocular infection at Visit 1 (bacterial, viral, or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation in either eye; 4. Have moderate or severe dry eye defined as total corneal fluorescein staining at Visit 1; 5. Have clinically significant abnormal lens findings during dilated slit-lamp biomicroscopy and fundus exam at Visit 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | 7 visits over a total duration of approximately 28 weeks | Percentage of subjects who experience adverse events and monocular BCDVA changes at 4m. |
Countries
United States
Outcome results
None listed