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

Phase 2

Completed

• Conditions: Presbyopia; Refractive Errors; Eye Diseases
• Interventions: Drug: Aceclidine+Brimonidine combination ophthalmic solution; Drug: Aceclidine ophthalmic solution; Drug: Vehicle proprietary ophthalmic solution

• Registration Number: NCT05431543
• Lead Sponsor: Alisyn Facemire

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-24
• Study Start: 2022-08-06
• Primary Completion: 2022-12-14
• Status Verified: 2023-01
• Study Completion: 2023-01-09
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Combination ophthalmic solution (LNZ101) dosed bilaterally	Aceclidine+Brimonidine combination ophthalmic solution	LNZ 101: Aceclidine/Brimonidine combination ophthalmic solution
Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally	Aceclidine ophthalmic solution	LNZ 100: Aceclidine ophthalmic solution
Vehicle Ophthalmic Solution dosed bilaterally	Vehicle proprietary ophthalmic solution	Proprietary vehicle ophthalmic solution

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision	1 hour post treatment	Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision

Trial Locations

Locations (5)

INSIGHT-2 Study Site #4; 🇺🇸 Houston, Texas, United States

INSIGHT-2 Study Site #3; 🇺🇸 Glendale, California, United States

INSIGHT-2 Study Site #1; 🇺🇸 Andover, Massachusetts, United States

INSIGHT-2 Study Site #2; 🇺🇸 Memphis, Tennessee, United States

INSIGHT-2 Study Site #5; 🇺🇸 Chandler, Arizona, United States