Presbyopia, Near Vision, Refractive Error, Eye Diseases
Conditions
Keywords
Pharmaceutical Solutions, Ophthalmic Solutions, Eye Drops, CLARITY, Presbyopia, Miotics
Brief summary
Phase 3 Efficacy Study to evaluate the Safety and Efficacy of LNZ100 & LNZ101 for the Treatment of Presbyopia
Detailed description
Phase 3 study to evaluate the safety and effectiveness of LNZ101 compared with LNZ100 and Vehicle for the treatment of Presbyopia.
Interventions
Aceclidine + Brimonidine combination ophthalmic solution
Aceclidine ophthalmic solution
DRUGVehicle
Proprietary vehicle ophthalmic solution
Sponsors
LENZ Therapeutics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A multi-center, double masked, randomized, controlled, efficacy and safety study
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects 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 at Visit 1; 4. Have +1.00 to -4.00 diopter (D) of sphere calculated in minus cylinder (so that spherical equivalent (SE) results in myopia no more severe than -4.00 D MRSE) in both eyes determined by manifest refraction documented at Visit 1; 5. Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1; 6. Be presbyopic as determined at Visit 1
Exclusion criteria
Subjects must NOT: 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 or at Visit 2 (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 central corneal fluorescein staining in either eye at Visit 1; 5. Have clinically significant abnormal lens findings including early lens changes during dilated slit lamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision | 3 hours post-treatment in the study eye on Day 1 | Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision on Day 1 |
Countries
United States
Contacts
STUDY_DIRECTORKris Gambelin, BS
LENZ Therapeutics, Inc
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54.4 years STANDARD_DEVIATION 5.45 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 208 Participants |
| Sex: Female, Male Female | 149 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 77 | 0 / 76 |
| other Total, other adverse events | 39 / 76 | 37 / 77 | 14 / 76 |
| serious Total, serious adverse events | 0 / 76 | 0 / 77 | 1 / 76 |
Outcome results
None listed