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

Presbyopia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06045299
• Other study ID #: JX07001
• Secondary ID: CTR20232913
• Status: Recruiting
• Phase: Phase 3
• Start date: September 27, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
• Contact: Rao
• Phone: 86-1085959061
• Email: Jennifer.rao[@]jixingbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Eye Diseases
• Miosis
• Near Vision
• Presbyopia

Intervention

Drug:
• Aceclidine+Brimonidine combination ophthalmic solution
Aceclidine+Brimonidine combination ophthalmic solution
• Aceclidine ophthalmic solution
Aceclidine ophthalmic solution
• Placebo (Vehicle) ophthalmic solution
Placebo (Vehicle) ophthalmic solution

Locations

Country	Name	City	State
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	Guang Zhou Aier eye Hospital	Guangzhou
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou
China	The Affiliated Hospital of Guizhou Medical University	Guizhou
China	Henan Eye Hospital & Henan Institute	Henan
China	The affiliated Hospital of Inner Mongolia Medical University	Hohhot
China	Affiliated Eye Hospital, Shandong University of Traditional Chinese Medicine	Shandong
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	Shanxi
China	West China Hospital, Sichuan University	Sichuan
China	Tianjin Eye Hospital	Tianjin
China	Tianjin Medical University Eye Hospital	Tianjin
China	Eye Hospital, Wenzhou Medical University	Wenzhou	Zhejiang
China	Wuhan Aier Eye Hospital	Wuhan
China	Xi'An People's Hospital	Xi'an

Sponsors (2)

Lead Sponsor	Collaborator
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.	LENZ Therapeutics, Inc

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)