Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia
- Conditions
- PresbyopiaRefractive ErrorNear VisionMiosisEye Diseases
- Interventions
- Registration Number
- NCT05656027
- Lead Sponsor
- LENZ Therapeutics, Inc
- Brief Summary
Phase 3 study to evaluate the safety and effectiveness of LNZ101 for the treatment of Presbyopia.
- Detailed Description
Phase 3 study to evaluate the safety and effectiveness of LNZ101 compared with LNZ100 and Brimonidine for the treatment of Presbyopia.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 469
- Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form 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 and any race or ethnicity at Visit 1;
- Have +1.00 to -4.00 diopter (D) of sphere calculated in minus cylinder (so that spherical equivalent (SE) results in myopia no more severe than -4.00 D MRSE) 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;
- Be presbyopic as determined at Visit 1
Subjects must not:
- 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 in either eye;
- Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1;
- Have clinically significant abnormal lens findings including early lens changes in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aceclidine + Brimonidine (LNZ101) dosed bilaterally Aceclidine + Brimonidine LNZ101 (Aceclidine /Brimonidine) ophthalmic solution Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally Aceclidine LNZ100 (Aceclidine) ophthalmic solution Brimonidine ophthalmic solution dosed bilaterally Brimonidine Brimonidine ophthalmic solution
- Primary Outcome Measures
Name Time Method Primary Outcome 3 hours post-treatment in the study eye Efficacy Study of the percentage of subjects who achieve a 3-line or greater improvement from baseline in the study eye with no loss in BCDVA ≥ 5 letters (ETDRS chart at 4 m).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Site #121
🇺🇸Mesa, Arizona, United States
Site #104
🇺🇸Fargo, North Dakota, United States
Site #122
🇺🇸Phoenix, Arizona, United States
Site #116
🇺🇸Memphis, Tennessee, United States
Site #106
🇺🇸Chandler, Arizona, United States
Site #124
🇺🇸Phoenix, Arizona, United States
Site #125
🇺🇸Sun City, Arizona, United States
Site #101
🇺🇸Glendale, California, United States
Site #110
🇺🇸Garden Grove, California, United States
Site #107
🇺🇸Petaluma, California, United States
Site #112
🇺🇸Smyrna, Tennessee, United States
Site #102
🇺🇸Mount Dora, Florida, United States
Site #118
🇺🇸Rock Island, Illinois, United States
Site #103
🇺🇸Kingston, Pennsylvania, United States
Site #119
🇺🇸San Antonio, Texas, United States
Site #123
🇺🇸San Antonio, Texas, United States
Site #111
🇺🇸Santa Barbara, California, United States
Site #109
🇺🇸Littleton, Colorado, United States
Site #108
🇺🇸Pittsburg, Kansas, United States
Site #126
🇺🇸Rancho Cordova, California, United States