Phase 3 Safety Study for the Treatment of Presbyopia Subjects

Phase 3

Completed

Conditions: Eye Diseases
Near Vision
Miosis
Presbyopia

Interventions: Drug: Placebo
Drug: Aceclidine Ophthalmic Solution
Drug: Aceclidine+Brimonidine combination ophthalmic solution

Registration Number: NCT05753189

Lead Sponsor: LENZ Therapeutics, Inc

Brief Summary: Safety Study of the Long-Term Safety of LNZ101 in Presbyopic Subjects

Detailed Description: Safety Study: Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 362

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (Vehicle) ophthalmic solution dosed bilaterally	Placebo	Placebo: Proprietary Vehicle Ophthalmic Solution
Aceclidine ophthalmic solution dosed bilaterally	Aceclidine Ophthalmic Solution	LNZ 100: Aceclidine ophthalmic solution
Combination ophthalmic solution (LNZ101) dosed bilaterally	Aceclidine+Brimonidine combination ophthalmic solution	LNZ 101: Aceclidine/Brimonidine Ophthalmic Solution

Primary Outcome Measures

Name	Time	Method
Primary Objective	7 visits over a total duration of approximately 28 weeks	Percentage of subjects who experience adverse events and monocular BCDVA changes at 4m.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (36): Site #304
🇺🇸
Santa Barbara, California, United States
Site #312
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Cranberry Township, Pennsylvania, United States
Site #311
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Smyrna, Tennessee, United States
Site #320
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Mesa, Arizona, United States
Site #319
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Crystal River, Florida, United States
Site #302
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Chandler, Arizona, United States
Site #326
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Dothan, Alabama, United States
Site #321
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Phoenix, Arizona, United States
Site #328
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Phoenix, Arizona, United States
Site #338
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Scottsdale, Arizona, United States
Site #331
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Sun City, Arizona, United States
Site #303
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Garden Grove, California, United States
Site #313
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Glendale, California, United States
Site #334
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La Jolla, California, United States
Site #322
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Newport Beach, California, United States
Site #301
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Overland Park, Kansas, United States
Site #306
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Petaluma, California, United States
Site #337
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Rancho Cordova, California, United States
Site #324
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Louisville, Kentucky, United States
Site #308
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Littleton, Colorado, United States
Site #316
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Danbury, Connecticut, United States
Site #309
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Mount Dora, Florida, United States
Site #317
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Rock Island, Illinois, United States
Site #336
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Alexandria, Minnesota, United States
Site #307
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Pittsburg, Kansas, United States
Site #330
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Kansas City, Missouri, United States
Site #335
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Bozeman, Montana, United States
Site #310
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Fargo, North Dakota, United States
Site #332
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W. Fargo, North Dakota, United States
Site #329
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Cincinnati, Ohio, United States
Site #323
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Powell, Ohio, United States
Site #333
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Eugene, Oregon, United States
Site #315
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Memphis, Tennessee, United States
Site #314
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El Paso, Texas, United States
Site #327
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San Antonio, Texas, United States
Site #318
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San Antonio, Texas, United States