Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia

LENZ Therapeutics

Status and phase: Completed; Phase 2

Conditions: Refractive Errors; Presbyopia; Eye Diseases

Treatments: Drug: Vehicle Proprietary Ophthalmic Solution; Drug: Aceclidine+Brimonidine combination ophthalmic solution; Drug: Aceclidine ophthalmic solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05294328

21-100-0007

Details and patient eligibility

About

To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.

Enrollment: 68 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Subjects MUST:

1. Be able and willing to provide written informed consent and sign 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 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 (so that SE results in myopia no more severe than -4.00 SE. See Inclusion 5 below) in both eyes determined by manifest refraction documented at Visit 1;
5. Have up to 2.00D 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(s) 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 (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye;
4. Have moderate or severe dry eye determined by total corneal fluorescein staining at Visit 1;
5. Have clinically significant abnormal lens findings (e.g., cataract) including early lens changes and/or any evidence of a media opacity in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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68 participants in 3 patient groups

Combination ophthalmic solution (LNZ101) dosed bilaterally

Experimental group

Description:

LNZ101: Aceclidine/Brimonidine combination 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:

Proprietary Vehicle ophthalmic solution

Treatment:

Drug: Vehicle Proprietary Ophthalmic Solution