Clinical trial NCT05753189: Phase 3 Safety Study for the Treatment of Presbyopia Subjects
Official title: Safety Study: A Multi-Center, Double-Masked Phase 3 Safety Study Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Presbyopia
Near Vision
Miosis
Eye Diseases
Keywords: Pharmaceutical Solutions
Opthalmic Solutions
Eye Drops
CLARITY
Presbyopia
Miotic
Lead sponsor: LENZ Therapeutics, Inc
Sponsor class: OTHER
Collaborators: name: ORA, Inc.
First posted: 2023-03-03
Enrollment: 362
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 Phase 3 Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects
Primary purpose: TREATMENT

Brief summary: Safety Study of the Long-Term Safety of LNZ101 in Presbyopic Subjects

Detailed description: Safety Study: Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects

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. Be presbyopic in both eyes as determined by manifest refraction documented at Visit 1;
5. Have +1.00 to -4.00 diopter(D) of sphere calculated in minus cylinder (up to 2.00D of cylinder) in both eyes determined by manifest refraction documented at Visit 1

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 (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 corneal fluorescein staining at Visit 1;
5. Have clinically significant abnormal lens findings during dilated slit-lamp biomicroscopy and fundus exam at Visit 1

Primary outcomes:
measure: Primary Objective
timeFrame: 7 visits over a total duration of approximately 28 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Site #326
state: Alabama
city: Chandler
country: United States
facility: Site #302
state: Arizona
city: Mesa
country: United States
facility: Site #320
state: Arizona
city: Phoenix
country: United States
facility: Site #321
state: Arizona
city: Phoenix
country: United States
facility: Site #328
state: Arizona
city: Scottsdale
country: United States
facility: Site #338
state: Arizona
city: Sun City
country: United States
facility: Site #331
state: Arizona
city: Garden Grove
country: United States
facility: Site #303
state: California
city: Glendale
country: United States
facility: Site #313
state: California
city: La Jolla
country: United States
facility: Site #334
state: California
city: Newport Beach
country: United States
facility: Site #322
state: California
city: Petaluma
country: United States
facility: Site #306
state: California
city: Rancho Cordova
country: United States
facility: Site #337
state: California
city: Santa Barbara
country: United States
facility: Site #304
state: California
city: Littleton
country: United States
facility: Site #308
state: Colorado
city: Danbury
country: United States
facility: Site #316
state: Connecticut
city: Crystal River
country: United States
facility: Site #319
state: Florida
city: Mount Dora
country: United States
facility: Site #309
state: Florida
city: Rock Island
country: United States
facility: Site #317
state: Illinois
city: Overland Park
country: United States
facility: Site #301
state: Kansas
city: Pittsburg
country: United States
facility: Site #307
state: Kansas
city: Louisville
country: United States
facility: Site #324
state: Kentucky
city: Alexandria
country: United States
facility: Site #336
state: Minnesota
city: Kansas City
country: United States
facility: Site #330
state: Missouri
city: Bozeman
country: United States
facility: Site #335
state: Montana
city: Fargo
country: United States
facility: Site #310
state: North Dakota
city: W. Fargo
country: United States
facility: Site #332
state: North Dakota
city: Cincinnati
country: United States
facility: Site #329
state: Ohio
city: Powell
country: United States
facility: Site #323
state: Ohio
city: Eugene
country: United States
facility: Site #333
state: Oregon
city: Cranberry Township
country: United States
facility: Site #312
state: Pennsylvania
city: Memphis
country: United States
facility: Site #315
state: Tennessee
city: Smyrna
country: United States
facility: Site #311
state: Tennessee
city: El Paso
country: United States
facility: Site #314
state: Texas
city: San Antonio
country: United States
facility: Site #327
state: Texas
city: San Antonio
country: United States
facility: Site #318
state: Texas
Study officials:
affiliation: LENZ Therapeutics
name: Alisyn Facemire, BA
role: STUDY_DIRECTOR
References: