Phase 3 Safety Study of LNZ100 and LNZ101 for the Treatment of Presbyopia Subjects
Safety Study: A Multi-Center, Double-Masked Phase 3 Safety Study Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects
1 other identifier
interventional
362
1 country
40
Brief Summary
Safety Study of the Long-Term Safety of LNZ100 \& LNZ101 in Presbyopic Subjects
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 Feb 2023
Shorter than P25 for phase_3
40 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 7, 2023
CompletedStudy Start
First participant enrolled
February 21, 2023
CompletedFirst Posted
Study publicly available on registry
March 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2024
CompletedResults Posted
Study results publicly available
May 13, 2026
CompletedMay 13, 2026
May 1, 2026
12 months
February 7, 2023
February 5, 2026
May 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With at Least One Treatment-Related TEAE
Number and Percentage of Participants with at least one Treatment-Related Treatment-Emergent Adverse Events (TEAE) were collected by systematic assessment and coded using MedDRA.
7 visits over a total duration of approximately 28 weeks
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
Vehicle
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 (40)
Site #326
Dothan, Alabama, 36301, United States
Site #302
Chandler, Arizona, 85224, United States
Site #320
Mesa, Arizona, 85202, United States
Site #321
Phoenix, Arizona, 85032, United States
Site #328
Phoenix, Arizona, 85053, United States
Site #338
Scottsdale, Arizona, 85260, United States
Site #331
Sun City, Arizona, 85351, United States
Site #303
Garden Grove, California, 92843, United States
Site #313
Glendale, California, 91204, United States
Site #334
La Jolla, California, 92037, United States
Site #322
Newport Beach, California, 92663, United States
Site #306
Petaluma, California, 94954, United States
Site #337
Rancho Cordova, California, 95670, United States
Site #304
Santa Barbara, California, 93105, United States
Site #308
Littleton, Colorado, 80120, United States
Site #316
Danbury, Connecticut, 06810, United States
Site #319
Crystal River, Florida, 34429, United States
Site #309
Mt. Dora, Florida, 32757, United States
Site #339
Morrow, Georgia, 30260, United States
Site #340
Northbrook, Illinois, 60062, United States
Site #317
Rock Island, Illinois, 61201, United States
Site #301
Overland Park, Kansas, 66210, United States
Site #307
Pittsburg, Kansas, 66762, United States
Site #324
Louisville, Kentucky, 40206, United States
Site #336
Alexandria, Minnesota, 56308, United States
Site #330
Kansas City, Missouri, 64154, United States
Site #325
St Louis, Missouri, 63128, United States
Site #335
Bozeman, Montana, 59718, United States
Site #341
Dover, New Jersey, 07801, United States
Site #310
Fargo, North Dakota, 58103, United States
Site #332
West Fargo, North Dakota, 58078, United States
Site #329
Cincinnati, Ohio, 45242, United States
Site #323
Powell, Ohio, 43065, United States
Site #333
Eugene, Oregon, 97401, United States
Site #312
Cranberry Township, Pennsylvania, 16066, United States
Site #315
Memphis, Tennessee, 38104, United States
Site #311
Smyrna, Tennessee, 37167, United States
Site #314
El Paso, Texas, 79902, United States
Site #318
San Antonio, Texas, 78229, United States
Site #327
San Antonio, Texas, 78229, 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
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double-masked treatment will be used to reduce potential of bias during data collection and the evaluation of clinical endpoints.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2023
First Posted
March 3, 2023
Study Start
February 21, 2023
Primary Completion
February 9, 2024
Study Completion
February 9, 2024
Last Updated
May 13, 2026
Results First Posted
May 13, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share