CLARITY: Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

Sponsor

LENZ Therapeutics, Inc (Other)

Overall Status

Recruiting

CT.gov ID

NCT05656027

Collaborator

ORA, Inc. (Industry)

435

Enrollment

Location

Arms

Anticipated Duration (Months)

36.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Phase 3 study to evaluate the safety and effectiveness of LNZ101 for the treatment of Presbyopia.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia Refractive Error Near Vision Miosis Eye Diseases	Drug: Aceclidine + Brimonidine Drug: Aceclidine Drug: Brimonidine	Phase 3

Detailed Description

Phase 3 study to evaluate the safety and effectiveness of LNZ101 compared with LNZ100 and Brimonidine for the treatment of Presbyopia.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

435 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A multi-center, double-masked, randomized, active-controlled, safety and efficacy studyA multi-center, double-masked, randomized, active-controlled, safety and efficacy study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

Anticipated Study Start Date :

Dec 19, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aceclidine + Brimonidine (LNZ101) dosed bilaterally LNZ101 (Aceclidine /Brimonidine) ophthalmic solution	Drug: Aceclidine + Brimonidine LNZ101 (Aceclidine/Brimonidine) ophthalmic solution
Experimental: Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally LNZ100 (Aceclidine) ophthalmic solution	Drug: Aceclidine LNZ100 Aceclidine ophthalmic solution
Experimental: Brimonidine ophthalmic solution dosed bilaterally Brimonidine ophthalmic solution	Drug: Brimonidine Brimonidine ophthalmic solution

Arm

Intervention/Treatment

Experimental: Aceclidine + Brimonidine (LNZ101) dosed bilaterally

LNZ101 (Aceclidine /Brimonidine) ophthalmic solution

Drug: Aceclidine + Brimonidine

LNZ101 (Aceclidine/Brimonidine) ophthalmic solution

Experimental: Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally

LNZ100 (Aceclidine) ophthalmic solution

Drug: Aceclidine

LNZ100 Aceclidine ophthalmic solution

Experimental: Brimonidine ophthalmic solution dosed bilaterally

Brimonidine ophthalmic solution

Drug: Brimonidine

Brimonidine ophthalmic solution

Outcome Measures

Primary Outcome Measures

Primary Outcome [3 hours post-treatment in the study eye]
Efficacy Study of the percentage of subjects who achieve a 3-line or greater improvement from baseline in the study eye with no loss in BCDVA ≥ 5 letters (ETDRS chart at 4 m).

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;
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;
Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
Be presbyopic as determined at Visit 1

Exclusion Criteria:

Subjects must not:

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 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;
Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1;
Have clinically significant abnormal lens findings including early lens changes in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;