Clinical trial NCT05656027: Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia
Official title: A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Presbyopia
Refractive Error
Near Vision
Miosis
Eye Diseases
Keywords: Pharmaceutical Solutions
Eye Drops
CLARITY
Presbyopia
Ophthalmic Solutions
Miotic
Lead sponsor: LENZ Therapeutics, Inc
Sponsor class: OTHER
Collaborators: name: ORA, Inc.
First posted: 2022-12-19
Enrollment: 469
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multi-center, double-masked, randomized, active-controlled, safety and efficacy study
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. Be able and willing to follow all instructions and attend all study visits;
3. Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;
4. 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;
5. Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
6. Be presbyopic as determined at Visit 1

Exclusion Criteria:

Subjects must not:

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 in either eye;
4. Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1;
5. 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;

Primary outcomes:
measure: Primary Outcome
timeFrame: 3 hours post-treatment in the study eye
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Site #106
state: Arizona
city: Mesa
country: United States
facility: Site #121
state: Arizona
city: Phoenix
country: United States
facility: Site #122
state: Arizona
city: Phoenix
country: United States
facility: Site #124
state: Arizona
city: Sun City
country: United States
facility: Site #125
state: Arizona
city: Garden Grove
country: United States
facility: Site #110
state: California
city: Glendale
country: United States
facility: Site #101
state: California
city: Petaluma
country: United States
facility: Site #107
state: California
city: Rancho Cordova
country: United States
facility: Site #126
state: California
city: Santa Barbara
country: United States
facility: Site #111
state: California
city: Littleton
country: United States
facility: Site #109
state: Colorado
city: Mount Dora
country: United States
facility: Site #102
state: Florida
city: Rock Island
country: United States
facility: Site #118
state: Illinois
city: Pittsburg
country: United States
facility: Site #108
state: Kansas
city: Fargo
country: United States
facility: Site #104
state: North Dakota
city: Kingston
country: United States
facility: Site #103
state: Pennsylvania
city: Memphis
country: United States
facility: Site #116
state: Tennessee
city: Smyrna
country: United States
facility: Site #112
state: Tennessee
city: San Antonio
country: United States
facility: Site #119
state: Texas
city: San Antonio
country: United States
facility: Site #123
state: Texas
Study officials:
affiliation: LENZ Therapeutics
name: Alisyn Facemire, BA
role: STUDY_DIRECTOR
References: