Phase 3 Evaluation of the Safety and Efficacy of LNZ100 & LNZ101 for the Treatment of Presbyopia
CLARITY 1
A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia
1 other identifier
interventional
469
1 country
25
Brief Summary
Phase 3 study to evaluate the safety and effectiveness of LNZ100 \& LNZ101 for the treatment of Presbyopia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2022
Shorter than P25 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2022
CompletedFirst Posted
Study publicly available on registry
December 19, 2022
CompletedStudy Start
First participant enrolled
December 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2024
CompletedResults Posted
Study results publicly available
February 25, 2026
CompletedFebruary 25, 2026
February 1, 2026
12 months
December 9, 2022
February 5, 2026
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 on Day 1
3 hours post-treatment in the study eye on Day 1
Study Arms (3)
Aceclidine + Brimonidine (LNZ101) dosed bilaterally
EXPERIMENTALLNZ101 (Aceclidine /Brimonidine) ophthalmic solution
Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally
EXPERIMENTALLNZ100 (Aceclidine) ophthalmic solution
Brimonidine ophthalmic solution dosed bilaterally
EXPERIMENTALBrimonidine ophthalmic solution
Interventions
LNZ101 (Aceclidine/Brimonidine) ophthalmic solution
LNZ100 Aceclidine ophthalmic solution
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subjects must not:
- 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 in either eye during dilated slit lamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Site #106
Chandler, Arizona, 85224, United States
Site #121
Mesa, Arizona, 85202, United States
Site #122
Phoenix, Arizona, 85032, United States
Site #124
Phoenix, Arizona, 85053, United States
Site #128
Scottsdale, Arizona, 85260, United States
Site #125
Sun City, Arizona, 85351, United States
Site #130
Azusa, California, 91702, United States
Site #110
Garden Grove, California, 92843, United States
Site #101
Glendale, California, 91204, United States
Site #129
Newport Beach, California, 92663, United States
Site #107
Petaluma, California, 94954, United States
Site #126
Rancho Cordova, California, 95670, United States
Site #111
Santa Barbara, California, 93105, United States
Site #109
Littleton, Colorado, 80120, United States
Site #102
Mt. Dora, Florida, 32757, United States
Site #118
Rock Island, Illinois, 61201, United States
Site #127
Overland Park, Kansas, 66210, United States
Site #108
Pittsburg, Kansas, 66762, United States
Site #131
Rochester, New York, 14618, United States
Site #104
Fargo, North Dakota, 58103, United States
Site #103
Kingston, Pennsylvania, 18704, United States
Site #116
Memphis, Tennessee, 38104, United States
Site #112
Smyrna, Tennessee, 37167, United States
Site #119
San Antonio, Texas, 78229, United States
Site #123
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marc Odrich, MD
- Organization
- LENZ Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
Kris Gambelin, BS
LENZ Therapeutics, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2022
First Posted
December 19, 2022
Study Start
December 19, 2022
Primary Completion
December 15, 2023
Study Completion
January 25, 2024
Last Updated
February 25, 2026
Results First Posted
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share