Clinical trial NCT05728944: Phase 3 Efficacy Study 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
Near Vision
Miosis
Eye Diseases
Keywords: Pharmaceutical Solutions
Opthalmic Solutions
Eye Drops
CLARITY
Presbyopia
Miotic
Lead sponsor: LENZ Therapeutics, Inc
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 229
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, efficacy and safety study
Primary purpose: TREATMENT

Brief summary: Phase 3 Efficacy Study to evaluate the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

Detailed description: A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

Eligibility criteria: Inclusion Criteria: Subjects MUST:

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 2 baseline

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 during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;

Primary outcomes:
measure: Efficacy Study To evaluate the safety and efficacy of LNZ101/LNZ100 compared with vehicle for the treatment of Presbyopia.
timeFrame: 3 hours post-treatment in the study eye at Visit 2
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Site #209
state: Alabama
city: Scottsdale
country: United States
facility: Site #216
state: Arizona
city: La Jolla
country: United States
facility: Site #214
state: California
city: Newport Beach
country: United States
facility: Site #203
state: California
city: Danbury
country: United States
facility: Site #204
state: Connecticut
city: Crystal River
country: United States
facility: Site #205
state: Florida
city: Louisville
country: United States
facility: Site #211
state: Kentucky
city: Saint Louis
country: United States
facility: Site #208
state: Missouri
city: Bozeman
country: United States
facility: Site #215
state: Montana
city: W. Fargo
country: United States
facility: Site #212
state: North Dakota
city: Powell
country: United States
facility: Site #207
state: Ohio
city: Eugene
country: United States
facility: Site #213
state: Oregon
city: Warwick
country: United States
facility: Site #217
state: Rhode Island
Study officials:
affiliation: LENZ Therapeutics
name: Alisyn Facemire, BA
role: STUDY_DIRECTOR
References: