Presbyopia, Refractive Errors, Eye Diseases
Conditions
Keywords
Pharmaceutical Solutions, Miotics, Ophthalmic Solutions, Near Vision, Eye Drops, INSIGHT 2
Brief summary
To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.
Interventions
LNZ101-combination ophthalmic solution
LNZ100- aceclidine ophthalmic solution
Proprietary Vehicle ophthalmic solution
Sponsors
LENZ Therapeutics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Multicenter, double-masked, randomized, crossover, active and vehicle-controlled, safety and effectiveness study
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 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 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 (so that spherical equivalent (SE) results in myopia no more severe than -4.00D MRSE. See Inclusion 5 below) in both eyes determined by manifest refraction documented at Visit 1; 5. Have ≤ 2.00D 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
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(s) 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 (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) 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 in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of 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 | 1 hour post treatment | Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Crossover Sequence 1 (123) LNZ101 (1), LNZ100 (2), Vehicle (3) | 18 |
| Crossover Sequence 2 (231) LNZ100 (2), Vehicle (3), LNZ101 (1) | 18 |
| Crossover Sequence 3 (312) Vehicle (3), LNZ101 (1), LNZ100 (2) | 23 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Medical History | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Crossover Sequence 1 (123) | Crossover Sequence 2 (231) | Crossover Sequence 3 (312) | Total |
|---|---|---|---|---|
| Age, Continuous | 54.4 years STANDARD_DEVIATION 6.38 | 54.7 years STANDARD_DEVIATION 5.55 | 56 years STANDARD_DEVIATION 7.03 | 55.2 years STANDARD_DEVIATION 6.34 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 5 Participants | 6 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 13 Participants | 17 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 14 Participants | 19 Participants | 48 Participants |
| Sex: Female, Male Female | 9 Participants | 11 Participants | 17 Participants | 37 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 6 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 58 | 0 / 58 |
| other Total, other adverse events | 17 / 59 | 3 / 58 | 0 / 58 |
| serious Total, serious adverse events | 0 / 59 | 0 / 58 | 0 / 58 |
Outcome results
Primary
Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision
Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision
Time frame: 1 hour post treatment
Population: The treatment crossover design allowed for each treatment to be analyzed in all subjects. The primary efficacy analysis was performed on a mITT population of subjects meeting the baseline criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LNZ101 | Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision | 74.0 percentage of participants |
| LNZ100 | Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision | 75.5 percentage of participants |
| Vehicle Ophthalmic Solution | Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision | 4.3 percentage of participants |
p-value: <0.0001Generalized Estimating Equation (GEE)
p-value: <0.0001Generalized Estimating Equation (GEE)