Phase 3 Efficacy Study of LNZ101 for the Treatment of Presbyopia (CLARITY)
Presbyopia, Near Vision, Miosis
About this trial
This is an interventional treatment trial for Presbyopia focused on measuring Pharmaceutical Solutions, Opthalmic Solutions, Eye Drops, CLARITY, Presbyopia, Miotic
Eligibility Criteria
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;
Sites / Locations
- Site #209Recruiting
- Site #216Recruiting
- Site #214Recruiting
- Site #203Recruiting
- Site #204Recruiting
- Site #205Recruiting
- Site #211Recruiting
- Site #208Recruiting
- Site #215Recruiting
- Site #212Recruiting
- Site #207Recruiting
- Site #213Recruiting
- Site #217Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Aceclidine + Brimonidine (LNZ101) dosed bilaterally
Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally
Vehicle Ophthalmic Solution dosed bilaterally
LNZ101: Aceclidine + Brimonidine ophthalmic solution
LNZ100: Aceclidine ophthalmic solution
Vehicle ophthalmic solution