Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

Presbyopia Clinical Trial

— CLARITY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05656027
• Other study ID #: 22-150-0015
• Status: Completed
• Phase: Phase 3
• Start date: December 19, 2022
• Est. completion date: January 25, 2024

Study information

• Verified date: January 2024
• Source: LENZ Therapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 3 study to evaluate the safety and effectiveness of LNZ101 for the treatment of Presbyopia.

Description:

Phase 3 study to evaluate the safety and effectiveness of LNZ101 compared with LNZ100 and Brimonidine for the treatment of Presbyopia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 469
• Est. completion date: January 25, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Eye Diseases
• Miosis
• Near Vision
• Presbyopia
• Refractive Error
• Refractive Errors

Intervention

Drug:
• Aceclidine + Brimonidine
LNZ101 (Aceclidine/Brimonidine) ophthalmic solution
• Aceclidine
LNZ100 Aceclidine ophthalmic solution
• Brimonidine
Brimonidine ophthalmic solution

Locations

Country	Name	City	State
United States	Site #106	Chandler	Arizona
United States	Site #104	Fargo	North Dakota
United States	Site #110	Garden Grove	California
United States	Site #101	Glendale	California
United States	Site #103	Kingston	Pennsylvania
United States	Site #109	Littleton	Colorado
United States	Site #116	Memphis	Tennessee
United States	Site #121	Mesa	Arizona
United States	Site #102	Mount Dora	Florida
United States	Site #107	Petaluma	California
United States	Site #122	Phoenix	Arizona
United States	Site #124	Phoenix	Arizona
United States	Site #108	Pittsburg	Kansas
United States	Site #126	Rancho Cordova	California
United States	Site #118	Rock Island	Illinois
United States	Site #119	San Antonio	Texas
United States	Site #123	San Antonio	Texas
United States	Site #111	Santa Barbara	California
United States	Site #112	Smyrna	Tennessee
United States	Site #125	Sun City	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
LENZ Therapeutics, Inc	ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome	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).	3 hours post-treatment in the study eye