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

Study Timeline

• Study First Submitted: 2023-02-07
• Study Start: 2023-02-21
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-03
• Primary Completion: 2024-02-09
• Study Completion: 2024-02-09
• Disposition First Posted: 2024-03-12
• Status Verified: 2024-12
• Disposition First Submitted: 2024-12-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 362

Inclusion Criteria

1. 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;
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

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 (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

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.

Trial Locations

Locations (36)

Site #304; 🇺🇸 Santa Barbara, California, United States

Site #312; 🇺🇸 Cranberry Township, Pennsylvania, United States

Site #311; 🇺🇸 Smyrna, Tennessee, United States

Site #320; 🇺🇸 Mesa, Arizona, United States

Site #319; 🇺🇸 Crystal River, Florida, United States

Site #302; 🇺🇸 Chandler, Arizona, United States

Site #326; 🇺🇸 Dothan, Alabama, 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 #301; 🇺🇸 Overland Park, Kansas, United States

Site #306; 🇺🇸 Petaluma, California, United States

Site #337; 🇺🇸 Rancho Cordova, California, United States

Site #324; 🇺🇸 Louisville, Kentucky, United States

Site #308; 🇺🇸 Littleton, Colorado, United States

Site #316; 🇺🇸 Danbury, Connecticut, United States

Site #309; 🇺🇸 Mount Dora, Florida, United States

Site #317; 🇺🇸 Rock Island, Illinois, United States

Site #336; 🇺🇸 Alexandria, Minnesota, United States

Site #307; 🇺🇸 Pittsburg, Kansas, United States

Site #330; 🇺🇸 Kansas City, Missouri, United States

Site #335; 🇺🇸 Bozeman, Montana, United States

Site #310; 🇺🇸 Fargo, North Dakota, United States

Site #332; 🇺🇸 W. Fargo, North Dakota, United States

Site #329; 🇺🇸 Cincinnati, Ohio, United States

Site #323; 🇺🇸 Powell, Ohio, United States

Site #333; 🇺🇸 Eugene, Oregon, United States

Site #315; 🇺🇸 Memphis, Tennessee, United States

Site #314; 🇺🇸 El Paso, Texas, United States

Site #327; 🇺🇸 San Antonio, Texas, United States

Site #318; 🇺🇸 San Antonio, Texas, United States