NCT05753189CompletedPhase 3
Safety Study: A Multi-Center, Double-Masked Phase 3 Safety Study Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects
LENZ Therapeutics, Inc76 sites in 1 country362 target enrollmentStarted: February 21, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 362
- Locations
- 76
- Primary Endpoint
- Primary Objective
Study Overview
Brief Summary
Safety Study of the Long-Term Safety of LNZ100 & LNZ101 in Presbyopic Subjects
Detailed Description
Safety Study: Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ101 compared with LNZ100 in Presbyopic Subjects
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Double-masked treatment will be used to reduce potential of bias during data collection and the evaluation of clinical endpoints.
Eligibility Criteria
- Ages
- 45 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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;
- •Be able and willing to follow all instructions and attend all study visits;
- •Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;
- •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;
- •Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
- •Be presbyopic as determined at Visit 1
Exclusion Criteria
- •Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;
- •Have known contraindications or sensitivity to the use of any of the study medications or their components;
- •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;
- •Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1;
- •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
Arms & Interventions
Combination ophthalmic solution (LNZ101) dosed bilaterally
Experimental
LNZ 101: Aceclidine/Brimonidine Ophthalmic Solution
Intervention: Aceclidine+Brimonidine combination ophthalmic solution (Drug)
Aceclidine ophthalmic solution dosed bilaterally
Experimental
LNZ 100: Aceclidine ophthalmic solution
Intervention: Aceclidine Ophthalmic Solution (Drug)
Outcomes
Primary Outcomes
Primary Objective
Time Frame: 7 visits over a total duration of approximately 28 weeks
Percentage of subjects who experience adverse events and monocular BCDVA changes at 4m.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (76)
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