Phase 3 Efficacy Study of LNZ100 & LNZ101 for the Treatment of Presbyopia
CLARITY 2
A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia
1 other identifier
interventional
229
1 country
17
Brief Summary
Phase 3 Efficacy Study to evaluate the Safety and Efficacy 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 P25-P50 for phase_3
Started Mar 2023
Shorter than P25 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2023
CompletedFirst Posted
Study publicly available on registry
February 15, 2023
CompletedStudy Start
First participant enrolled
March 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2024
CompletedResults Posted
Study results publicly available
February 25, 2026
CompletedFebruary 25, 2026
February 1, 2026
9 months
February 6, 2023
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
Vehicle Ophthalmic Solution dosed bilaterally
EXPERIMENTALVehicle ophthalmic solution
Interventions
Aceclidine + Brimonidine combination ophthalmic solution
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:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Site #209
Dothan, Alabama, 36301, United States
Site #216
Scottsdale, Arizona, 85260, United States
Site #220
Glendale, California, 91204, United States
Site #214
La Jolla, California, 92037, United States
Site #203
Newport Beach, California, 92663, United States
Site #204
Danbury, Connecticut, 06810, United States
Site #205
Crystal River, Florida, 34429, United States
Site #218
Northbrook, Illinois, 60062, United States
Site #211
Louisville, Kentucky, 40206, United States
Site #208
St Louis, Missouri, 63128, United States
Site #215
Bozeman, Montana, 59718, United States
Site #219
Dover, New Jersey, 07801, United States
Site #221
Rochester, New York, 14626, United States
Site #212
West Fargo, North Dakota, 58078, United States
Site #207
Powell, Ohio, 43065, United States
Site #213
Eugene, Oregon, 97401, United States
Site #217
Warwick, Rhode Island, 02888, United States
MeSH Terms
Conditions
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
February 6, 2023
First Posted
February 15, 2023
Study Start
March 6, 2023
Primary Completion
December 14, 2023
Study Completion
January 24, 2024
Last Updated
February 25, 2026
Results First Posted
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share