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

Sponsor

Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06045299

Collaborator

LENZ Therapeutics, Inc (Other)

300

Enrollment

Locations

Arms

15.1

Anticipated Duration (Months)

15.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Phase 3 Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Treatment of Presbyopia

Condition or Disease	Intervention/Treatment	Phase
Presbyopia Near Vision Miosis Eye Diseases	Drug: Aceclidine+Brimonidine combination ophthalmic solution Drug: Aceclidine ophthalmic solution Drug: Placebo (Vehicle) ophthalmic solution	Phase 3

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 27, 2023

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LNZ101 (Aceclidine/Brimonidine) ophthalmic solution Aceclidine+Brimonidine combination ophthalmic solution	Drug: Aceclidine+Brimonidine combination ophthalmic solution Aceclidine+Brimonidine combination ophthalmic solution Other Names: LNZ101
Experimental: LNZ100 (Aceclidine) ophthalmic solution Aceclidine ophthalmic solution	Drug: Aceclidine ophthalmic solution Aceclidine ophthalmic solution Other Names: LNZ100
Placebo Comparator: Placebo (Vehicle) ophthalmic solution Placebo (Vehicle) ophthalmic solution	Drug: Placebo (Vehicle) ophthalmic solution Placebo (Vehicle) ophthalmic solution

Arm

Intervention/Treatment

Experimental: LNZ101 (Aceclidine/Brimonidine) ophthalmic solution

Aceclidine+Brimonidine combination ophthalmic solution

Drug: Aceclidine+Brimonidine combination ophthalmic solution

Aceclidine+Brimonidine combination ophthalmic solution

Other Names:

LNZ101

Experimental: LNZ100 (Aceclidine) ophthalmic solution

Aceclidine ophthalmic solution

Drug: Aceclidine ophthalmic solution

Aceclidine ophthalmic solution

Other Names:

LNZ100

Placebo Comparator: Placebo (Vehicle) ophthalmic solution

Placebo (Vehicle) ophthalmic solution

Drug: Placebo (Vehicle) ophthalmic solution

Placebo (Vehicle) ophthalmic solution

Outcome Measures

Primary Outcome Measures

Best-corrected distance visual acuity (BCDVA) at 40 cm [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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;

Contacts and Locations

Locations

	Site	City	State	Country
1	Eye Hospital, Wenzhou Medical University	Wenzhou	Zhejiang	China
2	Beijing Tongren Hospital, Capital Medical University	Beijing		China
3	Peking University First Hospital	Beijing		China
4	The Second Xiangya Hospital of Central South University	Changsha		China
5	Ineye Hospital of Chengdu University of TCM	Chengdu		China
6	Guang Zhou Aier eye Hospital	Guangzhou		China
7	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou		China
8	The Affiliated Hospital of Guizhou Medical University	Guizhou		China
9	Henan Eye Hospital & Henan Institute	Henan		China
10	The affiliated Hospital of Inner Mongolia Medical University	Hohhot		China
11	Affiliated Eye Hospital, Shandong University of Traditional Chinese Medicine	Shandong		China
12	Shanghai Eye Disease Prevention and Treatment Center	Shanghai		China
13	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School Of Medicine	Shanghai		China
14	Shanxi Eye Hospital	Shanxi		China
15	West China Hospital, Sichuan University	Sichuan		China
16	Tianjin Eye Hospital	Tianjin		China
17	Tianjin Medical University Eye Hospital	Tianjin		China
18	Wuhan Aier Eye Hospital	Wuhan		China
19	Xi'An People's Hospital	Xi'an		China