Phase 3 Safety Study for the Treatment of Presbyopia Subjects

Presbyopia Clinical Trial

Official title:

Safety Study: A Multi-Center, Double-Masked Phase 3 Safety Study Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05753189
• Other study ID #: 22-150-0017
• Status: Completed
• Phase: Phase 3
• Start date: February 21, 2023
• Est. completion date: February 9, 2024

Study information

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

Clinical Trial Summary

Safety Study of the Long-Term Safety of LNZ101 in Presbyopic Subjects

Description:

Safety Study: Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 361
• Est. completion date: February 9, 2024
• Est. primary completion date: February 9, 2024
• 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. Be presbyopic in both eyes as determined by manifest refraction documented at Visit 1;

5. Have +1.00 to -4.00 diopter(D) of sphere calculated in minus cylinder (up to 2.00D of cylinder) in both eyes determined by manifest refraction documented 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 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 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 during dilated slit-lamp biomicroscopy and fundus exam at Visit 1

Related Conditions & MeSH terms

• Eye Diseases
• Miosis
• Near Vision
• Presbyopia

Intervention

Drug:
• Aceclidine+Brimonidine combination ophthalmic solution
Combination ophthalmic solution of Aceclidine and Brimonidine
• Placebo
Placebo: Proprietary Vehicle Solution
• Aceclidine Ophthalmic Solution
Aceclidine

Locations

Country	Name	City	State
United States	Site #336	Alexandria	Minnesota
United States	Site #335	Bozeman	Montana
United States	Site #302	Chandler	Arizona
United States	Site #329	Cincinnati	Ohio
United States	Site #312	Cranberry Township	Pennsylvania
United States	Site #319	Crystal River	Florida
United States	Site #316	Danbury	Connecticut
United States	Site #326	Dothan	Alabama
United States	Site #314	El Paso	Texas
United States	Site #333	Eugene	Oregon
United States	Site #310	Fargo	North Dakota
United States	Site #303	Garden Grove	California
United States	Site #313	Glendale	California
United States	Site #330	Kansas City	Missouri
United States	Site #334	La Jolla	California
United States	Site #308	Littleton	Colorado
United States	Site #324	Louisville	Kentucky
United States	Site #315	Memphis	Tennessee
United States	Site #320	Mesa	Arizona
United States	Site #309	Mount Dora	Florida
United States	Site #322	Newport Beach	California
United States	Site #301	Overland Park	Kansas
United States	Site #306	Petaluma	California
United States	Site #321	Phoenix	Arizona
United States	Site #328	Phoenix	Arizona
United States	Site #307	Pittsburg	Kansas
United States	Site #323	Powell	Ohio
United States	Site #337	Rancho Cordova	California
United States	Site #317	Rock Island	Illinois
United States	Site #318	San Antonio	Texas
United States	Site #327	San Antonio	Texas
United States	Site #304	Santa Barbara	California
United States	Site #338	Scottsdale	Arizona
United States	Site #311	Smyrna	Tennessee
United States	Site #331	Sun City	Arizona
United States	Site #332	W. Fargo	North Dakota

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 Objective	Percentage of subjects who experience adverse events and monocular BCDVA changes at 4m.	7 visits over a total duration of approximately 28 weeks