Phase 3 Efficacy Study of LNZ101 for the Treatment of Presbyopia
NCT ID: NCT05728944
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
229 participants
INTERVENTIONAL
2023-03-06
2024-01-24
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 combination ophthalmic solution
Aceclidine + Brimonidine combination ophthalmic solution
Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally
LNZ100: Aceclidine ophthalmic solution
Aceclidine
Aceclidine ophthalmic solution
Vehicle Ophthalmic Solution dosed bilaterally
Vehicle ophthalmic solution
Vehicle
Proprietary vehicle ophthalmic solution
Interventions
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Aceclidine+Brimonidine combination ophthalmic solution
Aceclidine + Brimonidine combination ophthalmic solution
Aceclidine
Aceclidine ophthalmic solution
Vehicle
Proprietary vehicle ophthalmic solution
Other Intervention Names
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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 2 baseline
Exclusion Criteria
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 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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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 #209
Dothan, Alabama, United States
Site #216
Scottsdale, Arizona, United States
Site #214
La Jolla, California, United States
Site #203
Newport Beach, California, United States
Site #204
Danbury, Connecticut, United States
Site #205
Crystal River, Florida, United States
Site #211
Louisville, Kentucky, United States
Site #208
St Louis, Missouri, United States
Site #215
Bozeman, Montana, United States
Site #212
West Fargo, North Dakota, United States
Site #207
Powell, Ohio, United States
Site #213
Eugene, Oregon, United States
Site #217
Warwick, Rhode Island, United States
Countries
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Other Identifiers
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22-150-0018
Identifier Type: -
Identifier Source: org_study_id