Phase 3 Efficacy Study of LNZ101 for the Treatment of Presbyopia

Phase 3

Completed

Interventions: Drug: Vehicle
Drug: Aceclidine+Brimonidine combination ophthalmic solution
Drug: Aceclidine

Brief Summary: Phase 3 Efficacy Study to evaluate the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

Detailed Description: A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

Recruitment & Eligibility

Inclusion Criteria

Subjects MUST:

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;
Be able and willing to follow all instructions and attend all study visits;
Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;
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;
Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
Be presbyopic as determined at Visit 2 baseline

Exclusion Criteria

Subjects must NOT:

Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;
Have known contraindications or sensitivity to the use of any of the study medications or their components;
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;
Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1;
Have clinically significant abnormal lens findings including early lens changes during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Efficacy Study To evaluate the safety and efficacy of LNZ101/LNZ100 compared with vehicle for the treatment of Presbyopia.	3 hours post-treatment in the study eye at Visit 2	Percentage of subjects who achieve a 3-line or greater improvement from baseline in the study eye. compared with vehicle for the treatment of Presbyopia.

Secondary Outcome Measures

Name	Time	Method

Locations (13): Site #215
🇺🇸
Bozeman, Montana, United States
Site #216
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Scottsdale, Arizona, United States
Site #209
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Dothan, Alabama, United States
Site #214
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La Jolla, California, United States
Site #204
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Danbury, Connecticut, United States
Site #203
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Newport Beach, California, United States
Site #211
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Louisville, Kentucky, United States
Site #208
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Saint Louis, Missouri, United States
Site #212
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W. Fargo, North Dakota, United States
Site #213
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Eugene, Oregon, United States
Site #207
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Powell, Ohio, United States
Site #217
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Warwick, Rhode Island, United States
Site #205
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Crystal River, Florida, United States