Phase 3 Efficacy Study of LNZ100 & LNZ101 for the Treatment of Presbyopia

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

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 1

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;