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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06045299
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : October 26, 2023
Sponsor:
Collaborator:
LENZ Therapeutics, Inc
Information provided by (Responsible Party):
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : September 27, 2023
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Brimonidine

Arms and Interventions
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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 Name: LNZ101
Experimental: LNZ100 (Aceclidine) ophthalmic solution
Aceclidine ophthalmic solution
 Drug: Aceclidine ophthalmic solution
Aceclidine ophthalmic solution
Other Name: LNZ100
Placebo Comparator: Placebo (Vehicle) ophthalmic solution
Placebo (Vehicle) ophthalmic solution
 Drug: Placebo (Vehicle) ophthalmic solution
Placebo (Vehicle) ophthalmic solution


Outcome Measures
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Primary Outcome Measures :
  1. Best-corrected distance visual acuity (BCDVA) at 40 cm [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045299


Contacts
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Contact: Rao 86-1085959061 Jennifer.rao@jixingbio.com

Locations
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Sponsors and Collaborators
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
LENZ Therapeutics, Inc
Investigators
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Study Director: Larry Li Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
More Information
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Responsible Party: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
ClinicalTrials.gov Identifier: NCT06045299    
Other Study ID Numbers: JX07001
CTR20232913 ( Other Identifier: China CDE clincial trial registration )
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: October 26, 2023
Last Verified: October 2023

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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
Keywords provided by Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.:
Presbyopia
Pharmaceutical Solutions
Opthalmic Solutions
Eye Drops
Miotic
Additional relevant MeSH terms:
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Eye Diseases
Presbyopia
Refractive Errors
Brimonidine Tartrate
Pharmaceutical Solutions
Ophthalmic Solutions
Aceclidine
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
 Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Parasympathomimetics