Phase 3 Safety Study for the Treatment of Presbyopia Subjects
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: 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; Be presbyopic in both eyes as determined by manifest refraction documented at Visit 1; Have +1.00 to -4.00 diopter(D) of sphere calculated in minus cylinder (up to 2.00D of cylinder) in both eyes determined by manifest refraction documented at Visit 1 Exclusion Criteria: 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 (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 corneal fluorescein staining at Visit 1; Have clinically significant abnormal lens findings during dilated slit-lamp biomicroscopy and fundus exam at Visit 1
Sites / Locations
- Site #326
- Site #302
- Site #320
- Site #321
- Site #328
- Site #338
- Site #331
- Site #303
- Site #313
- Site #334
- Site #322
- Site #306
- Site #337
- Site #304
- Site #308
- Site #316
- Site #319
- Site #309
- Site #317
- Site #301
- Site #307
- Site #324
- Site #336
- Site #330
- Site #335
- Site #310
- Site #332
- Site #329
- Site #323
- Site #333
- Site #312
- Site #315
- Site #311
- Site #314
- Site #327
- Site #318
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Experimental
Combination ophthalmic solution (LNZ101) dosed bilaterally
Placebo (Vehicle) ophthalmic solution dosed bilaterally
Aceclidine ophthalmic solution dosed bilaterally
LNZ 101: Aceclidine/Brimonidine Ophthalmic Solution
Placebo: Proprietary Vehicle Ophthalmic Solution
LNZ 100: Aceclidine ophthalmic solution