Phase 3 Efficacy Study of LNZ100 & LNZ101 for the Treatment of Presbyopia (CLARITY 2)

LENZ Therapeutics

Status and phase: Completed; Phase 3

Conditions: Refractive Error; Presbyopia; Eye Diseases; Near Vision

Treatments: Drug: Vehicle; Drug: Aceclidine ophthalmic solution; Drug: Aceclidine+Brimonidine combination ophthalmic solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05728944

22-150-0018

Details and patient eligibility

About

Phase 3 Efficacy Study to evaluate the Safety and Efficacy of LNZ100 & LNZ101 for the Treatment of Presbyopia

Full description

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

Enrollment: 229 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Subjects MUST:

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

Exclusion Criteria: Subjects must NOT:

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 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;
4. Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1;
5. 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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229 participants in 3 patient groups

Aceclidine + Brimonidine (LNZ101) dosed bilaterally

Experimental group

Description:

LNZ101: Aceclidine + Brimonidine ophthalmic solution

Treatment:

Drug: Aceclidine+Brimonidine combination ophthalmic solution

Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally

Experimental group

Description:

LNZ100: Aceclidine ophthalmic solution

Treatment:

Drug: Aceclidine ophthalmic solution

Vehicle Ophthalmic Solution dosed bilaterally

Experimental group

Description:

Vehicle ophthalmic solution

Treatment:

Drug: Vehicle