Clinical trial NCT05294328: Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia
Official title: A Multicenter, Double-Masked Evaluation of the Safety and Effectiveness of Aceclidine /Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Presbyopia
Refractive Errors
Eye Diseases
Keywords: Pharmaceutical Solutions
Miotics
Ophthalmic Solutions
Near Vision
Eye Drops
INSIGHT 1
Lead sponsor: LENZ Therapeutics, Inc
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 68
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Multicenter, double-masked, randomized, crossover, active and vehicle-controlled, safety and effectiveness study
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.


Eligibility criteria: Inclusion Criteria:

Subjects MUST:

1. Be able and willing to provide written informed consent and sign 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 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 (so that SE results in myopia no more severe than -4.00 SE. See Inclusion 5 below) in both eyes determined by manifest refraction documented at Visit 1;
5. Have up to 2.00D 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(s) 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 (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye;
4. Have moderate or severe dry eye determined by total corneal fluorescein staining at Visit 1;
5. Have clinically significant abnormal lens findings (e.g., cataract) including early lens changes and/or any evidence of a media opacity in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1;

Primary outcomes:
measure: Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision
timeFrame: 1 hour post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: INSIGHT-1 Study Site #4
state: California
city: Indianapolis
country: United States
facility: INSIGHT-1 Study Site #3
state: Indiana
city: Andover
country: United States
facility: INSIGHT-1 Study Site #1
state: Massachusetts
city: Memphis
country: United States
facility: INSIGHT-1 Study Site #2
state: Tennessee
city: Houston
country: United States
facility: INSIGHT-1 Study Site #5
state: Texas
Study officials:
affiliation: LENZ Therapeutics, Inc
name: Alisyn Facemire, BA
role: STUDY_DIRECTOR
References: