Phase 3 Safety Study 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
36
Brief Summary
Safety Study of the Long-Term Safety of 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
36 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
CompletedDecember 18, 2024
December 1, 2024
12 months
February 7, 2023
December 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Objective
Percentage of subjects who experience adverse events and monocular BCDVA changes at 4m.
7 visits over a total duration of approximately 28 weeks
Study Arms (3)
Combination ophthalmic solution (LNZ101) dosed bilaterally
EXPERIMENTALLNZ 101: Aceclidine/Brimonidine Ophthalmic Solution
Placebo (Vehicle) ophthalmic solution dosed bilaterally
PLACEBO COMPARATORPlacebo: Proprietary Vehicle Ophthalmic Solution
Aceclidine ophthalmic solution dosed bilaterally
EXPERIMENTALLNZ 100: Aceclidine ophthalmic solution
Interventions
Combination ophthalmic solution of Aceclidine and Brimonidine
Placebo: Proprietary Vehicle Solution
Aceclidine
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;
- Be presbyopic in both eyes as determined by manifest refraction documented at Visit 1;
- Have +1.00 to -4.00 diopter(D) of sphere calculated in minus cylinder (up to 2.00D of cylinder) in both eyes determined by manifest refraction documented 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 (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 corneal fluorescein staining at Visit 1;
- Have clinically significant abnormal lens findings during dilated slit-lamp biomicroscopy and fundus exam at Visit 1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LENZ Therapeutics, Inclead
- ORA, Inc.collaborator
Study Sites (36)
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, 32256, United States
Site #309
Mt. Dora, Florida, 32757, 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 #335
Bozeman, Montana, 59718, 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 #327
San Antonio, Texas, 33309, United States
Site #318
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alisyn Facemire, BA
LENZ Therapeutics
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
December 18, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share