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

Phase 3

Completed

• Conditions: Presbyopia; Refractive Error; Near Vision; Miosis; Eye Diseases
• Interventions: Drug: Aceclidine + Brimonidine; Drug: Aceclidine; Drug: Brimonidine

• Registration Number: NCT05656027
• Lead Sponsor: LENZ Therapeutics, Inc

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2022-12-09
• Study Start: 2022-12-19
• Study First Posted: 2022-12-19
• Primary Completion: 2023-12-15
• Study Completion: 2024-01-25
• Disposition First Posted: 2024-01-31
• Status Verified: 2024-12
• Disposition First Submitted: 2024-12-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 469

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aceclidine + Brimonidine (LNZ101) dosed bilaterally	Aceclidine + Brimonidine	LNZ101 (Aceclidine /Brimonidine) ophthalmic solution
Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally	Aceclidine	LNZ100 (Aceclidine) ophthalmic solution
Brimonidine ophthalmic solution dosed bilaterally	Brimonidine	Brimonidine ophthalmic solution

Primary Outcome Measures

Name	Time	Method
Primary Outcome	3 hours post-treatment in the study eye	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).

Trial Locations

Locations (20)

Site #106; 🇺🇸 Chandler, Arizona, United States

Site #121; 🇺🇸 Mesa, Arizona, United States

Site #122; 🇺🇸 Phoenix, Arizona, United States

Site #124; 🇺🇸 Phoenix, Arizona, United States

Site #125; 🇺🇸 Sun City, Arizona, United States

Site #110; 🇺🇸 Garden Grove, California, United States

Site #101; 🇺🇸 Glendale, California, United States

Site #107; 🇺🇸 Petaluma, California, United States

Site #126; 🇺🇸 Rancho Cordova, California, United States

Site #111; 🇺🇸 Santa Barbara, California, United States

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