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Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia

A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Phase 3 Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Treatment of Presbyopia

NCT06045299•Corxel Pharmaceuticals

View on ClinicalTrials.gov

Summary

A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Phase 3 Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Treatment of Presbyopia

Detailed Description

A multicenter, randomized, double-masked, placebo-controlled efficacy and safety study . To evaluate the efficacy and safety of LNZ101 (Aceclidine 1.75%/Brimonidine 0.08%)/LNZ100 (Aceclidine 1.75%) compared with placebo for the treatment of presbyopia.

Eligibility

Age

45 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Be able and willing to provide written informed consent 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 at Visit 1;
•4. Have +1.00 to -4.00 diopter (D) of sphere calculated in minus cylinder 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. Have +1.00 D to -4.00 D manifest refraction spherical equivalent（MRSE）of Spherical equivalent (SE) determined by manifest refraction documented at Visit 1.
•7. Be presbyopic as determined at Visit 2 baseline

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 or at Visit 2 (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 at Visit 1, assessed by corneal fluorescein staining;
•5. Have clinically significant abnormal lens findings (e.g., cataract) including early lens changes and/or any evidence of a media opacity during dilated slitlamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;

Locations (19)

Eye Hospital, Wenzhou Medical University

Wenzhou, Zhejiang, China

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Peking University First Hospital

Beijing, China

The Second Xiangya Hospital of Central South University

Changsha, China

Ineye Hospital of Chengdu University of TCM

Chengdu, China

Dalian N0.3 people's hospital

Dalian, China

Guang Zhou Aier eye Hospital

Guangzhou, China

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, China

Affiliated Eye Hospital, Shandong University of Traditional Chinese Medicine

Jinan, China

Key Dates

Start Date

September 27, 2023

Primary Completion Date

August 19, 2024

Completion Date

January 27, 2025

Last Updated

March 3, 2025

Enrollment

300

ACTUAL participants

Conditions

PresbyopiaNear VisionMiosisEye Diseases

Interventions

Aceclidine+Brimonidine combination ophthalmic solution

DRUG

Aceclidine ophthalmic solution

DRUG

Placebo (Vehicle) ophthalmic solution

DRUG

IC-8 Apthera IOL New Enrollment Post Approval Study

NCT06060041

CataractPresbyopia+1 more

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RECRUITINGNA

Clinical Applications of Advanced Ophthalmic Imaging

NCT03135327

Multiple SclerosisDry Eye Syndromes+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia

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Exclusion Criteria

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