Evaluation of the Safety and Effectiveness of Aceclidine (LNZ101) and Aceclidine + Brimonidine (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: NCT05431543
• Other study ID #: 22-100-0003
• Status: Completed
• Phase: Phase 2
• Start date: August 6, 2022
• Est. completion date: January 9, 2023

Study information

• Verified date: January 2023
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 9, 2023
• Est. primary completion date: December 14, 2022
• 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 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 spherical equivalent (SE) results in myopia no more severe than -4.00D MRSE. See Inclusion 5 below) in both eyes determined by manifest refraction documented at Visit 1;

5. Have = 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:

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 defined as total corneal fluorescein staining at Visit 1;

5. Have clinically significant abnormal lens findings in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1

Related Conditions & MeSH terms

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

Intervention

Drug:
• Aceclidine+Brimonidine combination ophthalmic solution
LNZ101-combination ophthalmic solution
• Aceclidine ophthalmic solution
Aceclidine alone + vehicle
• Vehicle proprietary ophthalmic solution
Proprietary vehicle ophthalmic solution

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Alisyn Facemire	ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Variable	Percentage of subjects with at least a 3-line improvement in near visual acuity in the study eye.	1 hour post treatment