Plasma Pharmacokinetics and Safety of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia

LENZ Therapeutics

Status and phase: Completed; Phase 1

Conditions: Ophthalmic Solutions; Brimonidine Tartrate; Refractive Errors; Aceclidine; Presbyopia; Eye Diseases

Treatments: Drug: Aceclidine; Drug: Aceclidine + Brimonidine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05936489

22-100-0007

Details and patient eligibility

About

This is a single-center, open-label, randomized study to assess the plasma pharmacokinetic profile of LNZ101 and LNZ100.

Full description

To characterize the plasma pharmacokinetics and safety profile of LNZ101 and LNZ100 ophthalmic solutions in both eyes once a day for 8 days in healthy volunteers with presbyopia

Enrollment: 30 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Each subject 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;
  4. Be presbyopic in both eyes;

Exclusion criteria

• Each subject must not:

  1. Have known contraindications or sensitivity to the use of the investigational drug or its components, or any other medications required by the protocol;
  2. Have any active systemic or ocular disorder other than refractive disorder;
  3. Have prior, current or anticipated use of any contact lenses during study participation;
  4. Have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that could affect ophthalmic drop absorption;
  5. Have anticipated inability to stay confined on required study days;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

LNZ101

Other group

Description:

Aceclidine 1.75% / Brimonidine combination (non-preserved) ophthalmic solution

Treatment:

Drug: Aceclidine + Brimonidine

LNZ100

Other group

Description:

Aceclidine 1.75% (non-preserved) ophthalmic solution

Treatment:

Drug: Aceclidine