Phase 3 Safety Study for the Treatment of Presbyopia Subjects

Sponsor

LENZ Therapeutics, Inc (Other)

Overall Status

Recruiting

CT.gov ID

NCT05753189

Collaborator

ORA, Inc. (Industry)

300

Enrollment

Locations

Arms

10.3

Anticipated Duration (Months)

150

Patients Per Site

14.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Safety Study of the Long-Term Safety of LNZ101 in Presbyopic Subjects

Condition or Disease	Intervention/Treatment	Phase
Presbyopia Near Vision Miosis Eye Diseases	Drug: Aceclidine+Brimonidine combination ophthalmic solution Drug: Placebo Drug: Aceclidine Ophthalmic Solution	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ101 in Presbyopic SubjectsA Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Double-masked treatment will be used to reduce potential of bias during data collection and the evaluation of clinical endpoints.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 21, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combination ophthalmic solution (LNZ101) dosed bilaterally LNZ 101: Aceclidine/Brimonidine Ophthalmic Solution	Drug: Aceclidine+Brimonidine combination ophthalmic solution Combination ophthalmic solution of Aceclidine and Brimonidine Other Names: LNZ101
Placebo Comparator: Placebo (Vehicle) ophthalmic solution dosed bilaterally Placebo: Proprietary Vehicle Ophthalmic Solution	Drug: Placebo Placebo: Proprietary Vehicle Solution Other Names: Vehicle
Experimental: Aceclidine ophthalmic solution dosed bilaterally LNZ 100: Aceclidine ophthalmic solution	Drug: Aceclidine Ophthalmic Solution Aceclidine Other Names: LNZ100

Arm

Intervention/Treatment

Experimental: Combination ophthalmic solution (LNZ101) dosed bilaterally

LNZ 101: Aceclidine/Brimonidine Ophthalmic Solution

Drug: Aceclidine+Brimonidine combination ophthalmic solution

Combination ophthalmic solution of Aceclidine and Brimonidine

Other Names:

LNZ101

Placebo Comparator: Placebo (Vehicle) ophthalmic solution dosed bilaterally

Placebo: Proprietary Vehicle Ophthalmic Solution

Drug: Placebo

Placebo: Proprietary Vehicle Solution

Other Names:

Vehicle

Experimental: Aceclidine ophthalmic solution dosed bilaterally

LNZ 100: Aceclidine ophthalmic solution

Drug: Aceclidine Ophthalmic Solution

Aceclidine

Other Names:

LNZ100

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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