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

Last updated: February 27, 2025
Sponsor: Corxel Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Presbyopia

Treatment

Aceclidine+Brimonidine combination ophthalmic solution

Aceclidine ophthalmic solution

Placebo (Vehicle) ophthalmic solution

Clinical Study ID

NCT06045299
JX07001
CTR20232913
  • Ages 45-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Be able and willing to provide written informed consent prior to any study procedurebeing 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 eyesdetermined by manifest refraction documented at Visit 1;

  5. Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifestrefraction documented at Visit 1;

  6. Have +1.00 D to -4.00 D manifest refraction spherical equivalent(MRSE)of Sphericalequivalent (SE) determined by manifest refraction documented at Visit 1.

  7. Be presbyopic as determined at Visit 2 baseline

Exclusion

Exclusion Criteria:

  1. Be a female of childbearing potential who is currently pregnant, nursing, orplanning a pregnancy;

  2. Have known contraindications or sensitivity to the use of any of the studymedications or their components;

  3. Have an active ocular infection at Visit 1 or at Visit 2 (bacterial, viral, orfungal), positive history of an ocular herpetic infection, preauricularlymphadenopathy, or ongoing, active ocular inflammation (e.g., moderate to severeblepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis,uveitis) in either eye;

  4. Have moderate or severe dry eye at Visit 1, assessed by corneal fluoresceinstaining;

  5. Have clinically significant abnormal lens findings (e.g., cataract) including earlylens changes and/or any evidence of a media opacity during dilated slitlampbiomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;

Study Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Aceclidine+Brimonidine combination ophthalmic solution
Phase: 3
Study Start date:
September 27, 2023
Estimated Completion Date:
January 27, 2025

Study 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.

Connect with a study center

  • Eye Hospital, Wenzhou Medical University

    Wenzhou, Zhejiang
    China

    Site Not Available

  • Beijing Tongren Hospital, Capital Medical University

    Beijing,
    China

    Site Not Available

  • Peking University First Hospital

    Beijing,
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha,
    China

    Site Not Available

  • Ineye Hospital of Chengdu University of TCM

    Chengdu,
    China

    Site Not Available

  • Dalian N0.3 people's hospital

    Dalian,
    China

    Site Not Available

  • Guang Zhou Aier eye Hospital

    Guangzhou,
    China

    Site Not Available

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou,
    China

    Site Not Available

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang,
    China

    Site Not Available

  • The Affiliated Hospital of Guizhou Medical University

    Guizhou,
    China

    Site Not Available

  • Henan Eye Hospital & Henan Institute

    Henan,
    China

    Site Not Available

  • The affiliated Hospital of Inner Mongolia Medical University

    Hohhot,
    China

    Site Not Available

  • Affiliated Eye Hospital, Shandong University of Traditional Chinese Medicine

    Jinan,
    China

    Site Not Available

  • Affiliated Eye Hospital, Shandong University of Traditional Chinese Medicine

    Shandong,
    China

    Site Not Available

  • Shanghai Eye Disease Prevention and Treatment Center

    Shanghai,
    China

    Site Not Available

  • Tongji Hospital Of Tongji University

    Shanghai,
    China

    Site Not Available

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School Of Medicine

    Shanghai,
    China

    Site Not Available

  • Shanxi Eye Hospital

    Shanxi,
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Sichuan,
    China

    Site Not Available

  • Shanxi Eye Hospital

    Taiyuan,
    China

    Site Not Available

  • Tianjin Eye Hospital

    Tianjin,
    China

    Site Not Available

  • Tianjin Medical University Eye Hospital

    Tianjin,
    China

    Site Not Available

  • Wuhan Aier Eye Hospital

    Wuhan,
    China

    Site Not Available

  • Xi'An People's Hospital

    Xi'an,
    China

    Site Not Available

  • Henan Eye Hospital & Henan Institute

    Zhengzhou,
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.