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
2 other identifiers
interventional
300
1 country
19
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2023
Shorter than P25 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedStudy Start
First participant enrolled
September 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2025
CompletedMarch 3, 2025
September 1, 2024
11 months
September 13, 2023
February 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best-corrected distance visual acuity (BCDVA) at 40 cm
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）
Study Arms (3)
LNZ101 (Aceclidine/Brimonidine) ophthalmic solution
EXPERIMENTALEnrolled 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.
LNZ100 (Aceclidine) ophthalmic solution
EXPERIMENTALEnrolled 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.
Placebo (Vehicle) ophthalmic solution
PLACEBO COMPARATOREnrolled 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.
Interventions
Aceclidine+Brimonidine combination ophthalmic solution
Aceclidine ophthalmic solution
Placebo (Vehicle) ophthalmic solution
Eligibility Criteria
You may qualify if:
- Be able and willing to provide written informed consent prior to any study procedure being performed;
- Be able and willing to follow all instructions and attend all study visits;
- Be 45-75 years of age of either sex at Visit 1;
- 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;
- Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
- 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.
- Be presbyopic as determined at Visit 2 baseline
You may not qualify if:
- Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;
- Have known contraindications or sensitivity to the use of any of the study medications or their components;
- 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;
- Have moderate or severe dry eye at Visit 1, assessed by corneal fluorescein staining;
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Corxel Pharmaceuticalslead
- LENZ Therapeutics, Inccollaborator
Study Sites (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
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, China
Tongji Hospital Of Tongji University
Shanghai, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School Of Medicine
Shanghai, China
Shanxi Eye Hospital
Taiyuan, China
Tianjin Eye Hospital
Tianjin, China
Tianjin Medical University Eye Hospital
Tianjin, China
Wuhan Aier Eye Hospital
Wuhan, China
Xi'An People's Hospital
Xi'an, China
Henan Eye Hospital & Henan Institute
Zhengzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gloria Sun
Corxel Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2023
First Posted
September 21, 2023
Study Start
September 27, 2023
Primary Completion
August 19, 2024
Study Completion
January 27, 2025
Last Updated
March 3, 2025
Record last verified: 2024-09