Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia
NCT ID: NCT05656027
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
469 participants
INTERVENTIONAL
2022-12-19
2024-01-25
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Aceclidine + Brimonidine (LNZ101) dosed bilaterally
LNZ101 (Aceclidine /Brimonidine) ophthalmic solution
Aceclidine + Brimonidine
LNZ101 (Aceclidine/Brimonidine) ophthalmic solution
Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally
LNZ100 (Aceclidine) ophthalmic solution
Aceclidine
LNZ100 Aceclidine ophthalmic solution
Brimonidine ophthalmic solution dosed bilaterally
Brimonidine ophthalmic solution
Brimonidine
Brimonidine ophthalmic solution
Interventions
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Aceclidine + Brimonidine
LNZ101 (Aceclidine/Brimonidine) ophthalmic solution
Aceclidine
LNZ100 Aceclidine ophthalmic solution
Brimonidine
Brimonidine ophthalmic solution
Eligibility Criteria
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Inclusion Criteria
2. Be able and willing to follow all instructions and attend all study visits;
3. Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;
4. 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;
5. Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
6. Be presbyopic as determined at Visit 1
Exclusion Criteria
1. Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;
2. Have known contraindications or sensitivity to the use of any of the study medications or their components;
3. 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;
4. Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1;
5. 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;
45 Years
75 Years
ALL
Yes
Sponsors
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ORA, Inc.
INDUSTRY
LENZ Therapeutics, Inc
OTHER
Responsible Party
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Principal Investigators
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Alisyn Facemire, BA
Role: STUDY_DIRECTOR
LENZ Therapeutics
Locations
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Site #106
Chandler, Arizona, United States
Site #121
Mesa, Arizona, United States
Site #122
Phoenix, Arizona, United States
Site #124
Phoenix, Arizona, United States
Site #125
Sun City, Arizona, United States
Site #110
Garden Grove, California, United States
Site #101
Glendale, California, United States
Site #107
Petaluma, California, United States
Site #126
Rancho Cordova, California, United States
Site #111
Santa Barbara, California, United States
Site #109
Littleton, Colorado, United States
Site #102
Mt. Dora, Florida, United States
Site #118
Rock Island, Illinois, United States
Site #108
Pittsburg, Kansas, United States
Site #104
Fargo, North Dakota, United States
Site #103
Kingston, Pennsylvania, United States
Site #116
Memphis, Tennessee, United States
Site #112
Smyrna, Tennessee, United States
Site #119
San Antonio, Texas, United States
Site #123
San Antonio, Texas, United States
Countries
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Other Identifiers
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22-150-0015
Identifier Type: -
Identifier Source: org_study_id