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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-06

Study Completion Date

2023-10-03

Brief Summary

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

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Detailed Description

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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

Conditions

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Eye Diseases Presbyopia Refractive Errors Brimonidine Tartrate Aceclidine Ophthalmic Solutions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

this is an open label study.

Study Groups

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LNZ101

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

Group Type OTHER

Aceclidine + Brimonidine

Intervention Type DRUG

LNZ101 (Aceclidine/Brimonidine) non-preserved ophthalmic solution

LNZ100

Aceclidine 1.75% (non-preserved) ophthalmic solution

Group Type OTHER

Aceclidine

Intervention Type DRUG

LNZ100 (Aceclidine) non-preserved ophthalmic solution

Interventions

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Aceclidine + Brimonidine

LNZ101 (Aceclidine/Brimonidine) non-preserved ophthalmic solution

Intervention Type DRUG

Aceclidine

LNZ100 (Aceclidine) non-preserved ophthalmic solution

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes