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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-05

Study Completion Date

2022-09-10

Brief Summary

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

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Detailed Description

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Conditions

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Presbyopia Refractive Errors Eye Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Multicenter, double-masked, randomized, crossover, active and vehicle-controlled, safety and effectiveness study

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Combination ophthalmic solution (LNZ101) dosed bilaterally

LNZ101: Aceclidine/Brimonidine combination ophthalmic solution

Group Type EXPERIMENTAL

Aceclidine+Brimonidine combination ophthalmic solution

Intervention Type DRUG

LNZ101-combination ophthalmic solution

Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally

LNZ100: Aceclidine ophthalmic solution

Group Type EXPERIMENTAL

Aceclidine ophthalmic solution

Intervention Type DRUG

LNZ100- aceclidine ophthalmic solution

Vehicle Ophthalmic Solution dosed bilaterally

Proprietary Vehicle ophthalmic solution

Group Type EXPERIMENTAL

Vehicle Proprietary Ophthalmic Solution

Intervention Type DRUG

Proprietary Vehicle Ophthalmic Solution

Interventions

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Aceclidine+Brimonidine combination ophthalmic solution

LNZ101-combination ophthalmic solution

Intervention Type DRUG

Aceclidine ophthalmic solution

LNZ100- aceclidine ophthalmic solution

Intervention Type DRUG

Vehicle Proprietary Ophthalmic Solution

Proprietary Vehicle Ophthalmic Solution

Intervention Type DRUG

Other Intervention Names

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LNZ101 Brimonidine and Aceclidine LNZ100 Aceclidine Vehicle

Eligibility Criteria

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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;

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes