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

Sponsor

LENZ Therapeutics, Inc (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05728944

Collaborator

ORA, Inc. (Industry)

222

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Phase 3 Efficacy Study to evaluate the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

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

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

222 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

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

Masking Description:

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

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 :

Mar 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aceclidine + Brimonidine (LNZ101) dosed bilaterally LNZ101: Aceclidine + Brimonidine ophthalmic solution	Drug: Aceclidine+Brimonidine combination ophthalmic solution Aceclidine + Brimonidine combination ophthalmic solution Other Names: LNZ101
Experimental: Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally LNZ100: Aceclidine ophthalmic solution	Drug: Aceclidine Aceclidine ophthalmic solution Other Names: LNZ100
Experimental: Vehicle Ophthalmic Solution dosed bilaterally Vehicle ophthalmic solution	Drug: Vehicle Proprietary vehicle ophthalmic solution

Arm

Intervention/Treatment

Experimental: Aceclidine + Brimonidine (LNZ101) dosed bilaterally

LNZ101: Aceclidine + Brimonidine ophthalmic solution

Drug: Aceclidine+Brimonidine combination ophthalmic solution

Aceclidine + Brimonidine combination ophthalmic solution

Other Names:

LNZ101

Experimental: Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally

LNZ100: Aceclidine ophthalmic solution

Drug: Aceclidine

Aceclidine ophthalmic solution

Other Names:

LNZ100

Experimental: Vehicle Ophthalmic Solution dosed bilaterally

Vehicle ophthalmic solution

Drug: Vehicle

Proprietary vehicle ophthalmic solution

Outcome Measures

Primary Outcome Measures

Efficacy Study To evaluate the safety and efficacy of LNZ101/LNZ100 compared with vehicle for the treatment of Presbyopia. [3 hours post-treatment in the study eye at Visit 2]
Efficacy Study of the percentage of subjects who achieve a 3-line or greater improvement from baseline in the study eye with no loss of BCDVA greater than or equal to 5 letters (ETDRS chart at 4m). compared with vehicle for the treatment of Presbyopia.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria: Subjects MUST:

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 2 baseline

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 during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;