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

February 27, 2025 updated by: Corxel Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University First Hospital
      • Beijing, China
        • Beijing Tongren Hospital, Capital Medical University
      • Changsha, China
        • The second Xiangya hospital of central south university
      • Chengdu, China
        • Ineye Hospital of Chengdu University of TCM
      • Dalian, China
        • Dalian N0.3 people's hospital
      • Guangzhou, China
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Guangzhou, China
        • Guang Zhou Aier eye Hospital
      • Guiyang, China
        • The Affiliated Hospital of Guizhou Medical University
      • Jinan, China
        • Affiliated Eye Hospital, Shandong University of Traditional Chinese Medicine
      • Shanghai, China
        • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Shanghai, China
        • Tongji Hospital of Tongji University
      • Shanghai, China
        • Shanghai Eye Disease Prevention and Treatment Center
      • Taiyuan, China
        • Shanxi Eye Hospital
      • Tianjin, China
        • Tianjin Eye Hospital
      • Tianjin, China
        • Tianjin Medical University Eye Hospital
      • Wuhan, China
        • Wuhan Aier Eye Hospital
      • Xi'an, China
        • Xi'an People's Hospital
      • Zhengzhou, China
        • Henan Eye Hospital & Henan Institute
    • Zhejiang
      • Wenzhou, Zhejiang, China
        • Eye Hospital, Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LNZ101 (Aceclidine/Brimonidine) ophthalmic solution
Enrolled subjects will be randomized to receive LNZ101, LNZ100, or placebo bilaterally once a day. Subjects will be instructed to dose 2 drops in both eyes (OU) (1 drop followed by 2 minutes later, another drop). Subjects will dose for 168 days.
Drug: Aceclidine+Brimonidine combination ophthalmic solution
Aceclidine+Brimonidine combination ophthalmic solution
Other Names:
  • LNZ101
Experimental: LNZ100 (Aceclidine) ophthalmic solution
Enrolled subjects will be randomized to receive LNZ101, LNZ100, or placebo bilaterally once a day. Subjects will be instructed to dose 2 drops in both eyes (OU) (1 drop followed by 2 minutes later, another drop). Subjects will dose for 168 days.
Drug: Aceclidine ophthalmic solution
Aceclidine ophthalmic solution
Other Names:
  • LNZ100
Placebo Comparator: Placebo (Vehicle) ophthalmic solution
Enrolled subjects will be randomized to receive LNZ101, LNZ100, or placebo bilaterally once a day. Subjects will be instructed to dose 2 drops in both eyes (OU) (1 drop followed by 2 minutes later, another drop). Subjects will dose for 168 days.
Drug: Placebo (Vehicle) ophthalmic solution
Placebo (Vehicle) ophthalmic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best-corrected distance visual acuity (BCDVA) at 40 cm
Time Frame: 3 hours post-treatment in the study eye at Visit 2 (Day 1）
Percentage of subjects who achieve a 3-line (15-letter) or greater improvement from baseline in the measurement of monocular BCDV at 40 cm and no loss in BCDVA ≥ 5 letters (ETDRS chart at 4 m)
3 hours post-treatment in the study eye at Visit 2 (Day 1）

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corxel Pharmaceuticals

Collaborators

LENZ Therapeutics, Inc

Investigators

  • Study Director: Gloria Sun, Corxel Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2023

Primary Completion (Actual)

August 19, 2024

Study Completion (Actual)

January 27, 2025

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JX07001
  • CTR20232913 (Other Identifier: China CDE clinical trial registration)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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