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

Primary Purpose

Presbyopia, Near Vision, Miosis

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Aceclidine+Brimonidine combination ophthalmic solution
Aceclidine ophthalmic solution
Placebo (Vehicle) ophthalmic solution
Sponsored by
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring Presbyopia, Pharmaceutical Solutions, Opthalmic Solutions, Eye Drops, Miotic

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • Eye Hospital, Wenzhou Medical UniversityRecruiting
  • Beijing Tongren Hospital, Capital Medical University
  • Peking University First Hospital
  • The Second Xiangya Hospital of Central South University
  • Ineye Hospital of Chengdu University of TCM
  • Guang Zhou Aier eye Hospital
  • Zhongshan Ophthalmic Center, Sun Yat-sen University
  • The Affiliated Hospital of Guizhou Medical University
  • Henan Eye Hospital & Henan Institute
  • The affiliated Hospital of Inner Mongolia Medical University
  • Affiliated Eye Hospital, Shandong University of Traditional Chinese Medicine
  • Shanghai Eye Disease Prevention and Treatment Center
  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School Of Medicine
  • Shanxi Eye Hospital
  • West China Hospital, Sichuan University
  • Tianjin Eye Hospital
  • Tianjin Medical University Eye Hospital
  • Wuhan Aier Eye Hospital
  • Xi'An People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

LNZ101 (Aceclidine/Brimonidine) ophthalmic solution

LNZ100 (Aceclidine) ophthalmic solution

Placebo (Vehicle) ophthalmic solution

Arm Description

Aceclidine+Brimonidine combination ophthalmic solution

Aceclidine ophthalmic solution

Placebo (Vehicle) ophthalmic solution

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
September 13, 2023
Last Updated
October 13, 2023
Sponsor
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
Collaborators
LENZ Therapeutics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT06045299
Brief Title
Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
Collaborators
LENZ Therapeutics, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia, Near Vision, Miosis, Eye Diseases
Keywords
Presbyopia, Pharmaceutical Solutions, Opthalmic Solutions, Eye Drops, Miotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LNZ101 (Aceclidine/Brimonidine) ophthalmic solution
Arm Type
Experimental
Arm Description
Aceclidine+Brimonidine combination ophthalmic solution
Arm Title
LNZ100 (Aceclidine) ophthalmic solution
Arm Type
Experimental
Arm Description
Aceclidine ophthalmic solution
Arm Title
Placebo (Vehicle) ophthalmic solution
Arm Type
Placebo Comparator
Arm Description
Placebo (Vehicle) ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Aceclidine+Brimonidine combination ophthalmic solution
Other Intervention Name(s)
LNZ101
Intervention Description
Aceclidine+Brimonidine combination ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Aceclidine ophthalmic solution
Other Intervention Name(s)
LNZ100
Intervention Description
Aceclidine ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Placebo (Vehicle) ophthalmic solution
Intervention Description
Placebo (Vehicle) ophthalmic solution
Primary Outcome Measure Information:
Title
Best-corrected distance visual acuity (BCDVA) at 40 cm
Description
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)
Time Frame
3 hours post-treatment in the study eye at Visit 2 (Day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rao
Phone
86-1085959061
Email
Jennifer.rao@jixingbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Li
Organizational Affiliation
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Eye Hospital, Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Tongren Hospital, Capital Medical University
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Ineye Hospital of Chengdu University of TCM
City
Chengdu
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Guang Zhou Aier eye Hospital
City
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guizhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Henan Eye Hospital & Henan Institute
City
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The affiliated Hospital of Inner Mongolia Medical University
City
Hohhot
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Affiliated Eye Hospital, Shandong University of Traditional Chinese Medicine
City
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Shanghai Eye Disease Prevention and Treatment Center
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School Of Medicine
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Shanxi Eye Hospital
City
Shanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Name
West China Hospital, Sichuan University
City
Sichuan
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Tianjin Eye Hospital
City
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Tianjin Medical University Eye Hospital
City
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Wuhan Aier Eye Hospital
City
Wuhan
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Xi'An People's Hospital
City
Xi'an
Country
China
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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