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

NCT ID: NCT06045299

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-27
• Study Completion Date: 2025-01-27

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

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.

Conditions

Presbyopia; Near Vision; Miosis; Eye Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Aceclidine+Brimonidine combination ophthalmic solution

Intervention Type: DRUG

Aceclidine+Brimonidine combination ophthalmic solution

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.

Group Type: EXPERIMENTAL

Aceclidine ophthalmic solution

Intervention Type: DRUG

Aceclidine ophthalmic solution

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.

Group Type: PLACEBO_COMPARATOR

Placebo (Vehicle) ophthalmic solution

Intervention Type: DRUG

Placebo (Vehicle) ophthalmic solution

Interventions

Aceclidine+Brimonidine combination ophthalmic solution

Aceclidine+Brimonidine combination ophthalmic solution

Intervention Type: DRUG

Aceclidine ophthalmic solution

Aceclidine ophthalmic solution

Intervention Type: DRUG

Placebo (Vehicle) ophthalmic solution

Placebo (Vehicle) ophthalmic solution

Intervention Type: DRUG

Other Intervention Names

LNZ101; LNZ100

Eligibility Criteria

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;

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LENZ Therapeutics, Inc

OTHER

Sponsor Role: collaborator

Corxel Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gloria Sun

Role: STUDY_DIRECTOR

Corxel Pharmaceuticals

Locations

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

Countries

China

Other Identifiers

CTR20232913

Identifier Type: OTHER

Identifier Source: secondary_id

JX07001

Identifier Type: -

Identifier Source: org_study_id