Phase 3 Safety Study for the Treatment of Presbyopia Subjects

LENZ Therapeutics

Status and phase: Completed; Phase 3

Conditions: Presbyopia; Eye Diseases; Miosis; Near Vision

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05753189

22-150-0017

Details and patient eligibility

About

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

Full description

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

Enrollment: 362 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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. Be presbyopic in both eyes as determined by manifest refraction documented at Visit 1;
5. 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

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 (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 corneal fluorescein staining at Visit 1;
5. Have clinically significant abnormal lens findings during dilated slit-lamp biomicroscopy and fundus exam at Visit 1

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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362 participants in 3 patient groups, including a placebo group

Combination ophthalmic solution (LNZ101) dosed bilaterally

Experimental group

Description:

LNZ 101: Aceclidine/Brimonidine Ophthalmic Solution

Treatment:

Drug: Aceclidine+Brimonidine combination ophthalmic solution

Placebo (Vehicle) ophthalmic solution dosed bilaterally

Placebo Comparator group

Description:

Placebo: Proprietary Vehicle Ophthalmic Solution

Treatment:

Drug: Placebo

Aceclidine ophthalmic solution dosed bilaterally

Experimental group

Description:

LNZ 100: Aceclidine ophthalmic solution

Treatment:

Drug: Aceclidine Ophthalmic Solution