Phase 3 Efficacy Study 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: NCT05728944
• Other study ID #: 22-150-0018
• Status: Completed
• Phase: Phase 3
• Start date: April 24, 2023
• Est. completion date: January 24, 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 Efficacy Study to evaluate the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: January 24, 2024
• Est. primary completion date: December 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Eye Diseases
• Miosis
• Near Vision
• Presbyopia

Intervention

Drug:
• Aceclidine+Brimonidine combination ophthalmic solution
Aceclidine + Brimonidine combination ophthalmic solution
• Aceclidine
Aceclidine ophthalmic solution
• Vehicle
Proprietary vehicle ophthalmic solution

Locations

Country	Name	City	State
United States	Site #215	Bozeman	Montana
United States	Site #205	Crystal River	Florida
United States	Site #204	Danbury	Connecticut
United States	Site #209	Dothan	Alabama
United States	Site #213	Eugene	Oregon
United States	Site #214	La Jolla	California
United States	Site #211	Louisville	Kentucky
United States	Site #203	Newport Beach	California
United States	Site #207	Powell	Ohio
United States	Site #208	Saint Louis	Missouri
United States	Site #216	Scottsdale	Arizona
United States	Site #212	W. Fargo	North Dakota
United States	Site #217	Warwick	Rhode Island

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	Efficacy Study To evaluate the safety and efficacy of LNZ101/LNZ100 compared with vehicle for the treatment of Presbyopia.	Percentage of subjects who achieve a 3-line or greater improvement from baseline in the study eye.; compared with vehicle for the treatment of Presbyopia.	3 hours post-treatment in the study eye at Visit 2