Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia

Presbyopia Clinical Trial

Official title:

A Multicenter, Double-Masked Evaluation of the Safety and Effectiveness of Aceclidine /Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05294328
• Other study ID #: 21-100-0007
• Status: Completed
• Phase: Phase 2
• Start date: May 5, 2022
• Est. completion date: September 10, 2022

Study information

• Verified date: October 2022
• Source: LENZ Therapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The primary efficacy variable in this INSIGHT study is the percentage of subjects with at least a 3-line improvement.

The secondary efficacy variable is the percentage of subjects who achieve a 2-line or greater improvement from pre-treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 10, 2022
• Est. primary completion date: August 22, 2022
• 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 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;

Related Conditions & MeSH terms

• Eye Diseases
• Presbyopia
• Refractive Errors

Intervention

Drug:
• Aceclidine+Brimonidine combination ophthalmic solution
Ophthalmic Solution
• Aceclidine ophthalmic solution
Ophthalmic Solution
• Vehicle Proprietary Ophthalmic Solution
Ophthalmic Solution

Locations

Country	Name	City	State
United States	INSIGHT-1 Study Site #1	Andover	Massachusetts
United States	INSIGHT-1 Study Site #4	Glendale	California
United States	INSIGHT-1 Study Site #5	Houston	Texas
United States	INSIGHT-1 Study Site #3	Indianapolis	Indiana
United States	INSIGHT-1 Study Site #2	Memphis	Tennessee

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	Percentage of Subjects With at Least a 3-line Improvement in Near Visual Acuity in the Study Eye	The percentage of subjects with at least a 3-line improvement from the pre-dose Aceclidine/Brimonidine (LNZ101) arm versus the vehicle arm, and the Aceclidine arm (LNZ100) versus the vehicle arm.	1 hour