Phase 3 Safety Study for the Treatment of Presbyopia Subjects
NCT ID: NCT05753189
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
362 participants
INTERVENTIONAL
2023-02-21
2024-02-09
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
TRIPLE
Study Groups
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Combination ophthalmic solution (LNZ101) dosed bilaterally
LNZ 101: Aceclidine/Brimonidine Ophthalmic Solution
Aceclidine+Brimonidine combination ophthalmic solution
Combination ophthalmic solution of Aceclidine and Brimonidine
Placebo (Vehicle) ophthalmic solution dosed bilaterally
Placebo: Proprietary Vehicle Ophthalmic Solution
Placebo
Placebo: Proprietary Vehicle Solution
Aceclidine ophthalmic solution dosed bilaterally
LNZ 100: Aceclidine ophthalmic solution
Aceclidine Ophthalmic Solution
Aceclidine
Interventions
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Aceclidine+Brimonidine combination ophthalmic solution
Combination ophthalmic solution of Aceclidine and Brimonidine
Placebo
Placebo: Proprietary Vehicle Solution
Aceclidine Ophthalmic Solution
Aceclidine
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. Be presbyopic in both eyes as determined by manifest refraction documented at Visit 1;
5. 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
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 (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 corneal fluorescein staining at Visit 1;
5. Have clinically significant abnormal lens findings during dilated slit-lamp biomicroscopy and fundus exam 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 #326
Dothan, Alabama, United States
Site #302
Chandler, Arizona, United States
Site #320
Mesa, Arizona, United States
Site #321
Phoenix, Arizona, United States
Site #328
Phoenix, Arizona, United States
Site #338
Scottsdale, Arizona, United States
Site #331
Sun City, Arizona, United States
Site #303
Garden Grove, California, United States
Site #313
Glendale, California, United States
Site #334
La Jolla, California, United States
Site #322
Newport Beach, California, United States
Site #306
Petaluma, California, United States
Site #337
Rancho Cordova, California, United States
Site #304
Santa Barbara, California, United States
Site #308
Littleton, Colorado, United States
Site #316
Danbury, Connecticut, United States
Site #319
Crystal River, Florida, United States
Site #309
Mt. Dora, Florida, United States
Site #317
Rock Island, Illinois, United States
Site #301
Overland Park, Kansas, United States
Site #307
Pittsburg, Kansas, United States
Site #324
Louisville, Kentucky, United States
Site #336
Alexandria, Minnesota, United States
Site #330
Kansas City, Missouri, United States
Site #335
Bozeman, Montana, United States
Site #310
Fargo, North Dakota, United States
Site #332
West Fargo, North Dakota, United States
Site #329
Cincinnati, Ohio, United States
Site #323
Powell, Ohio, United States
Site #333
Eugene, Oregon, United States
Site #312
Cranberry Township, Pennsylvania, United States
Site #315
Memphis, Tennessee, United States
Site #311
Smyrna, Tennessee, United States
Site #314
El Paso, Texas, United States
Site #327
San Antonio, Texas, United States
Site #318
San Antonio, Texas, United States
Countries
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Other Identifiers
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22-150-0017
Identifier Type: -
Identifier Source: org_study_id