Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia
Presbyopia, Near Vision, Miosis
About this trial
This is an interventional treatment trial for Presbyopia focused on measuring Presbyopia, Pharmaceutical Solutions, Opthalmic Solutions, Eye Drops, Miotic
Eligibility Criteria
Inclusion Criteria: Be able and willing to provide written informed consent 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 at Visit 1; Have +1.00 to -4.00 diopter (D) of sphere calculated in minus cylinder 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; Have +1.00 D to -4.00 D manifest refraction spherical equivalent(MRSE)of Spherical equivalent (SE) determined by manifest refraction documented at Visit 1. Be presbyopic as determined at Visit 2 baseline 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 or at Visit 2 (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; Have moderate or severe dry eye at Visit 1, assessed by corneal fluorescein staining; Have clinically significant abnormal lens findings (e.g., cataract) including early lens changes and/or any evidence of a media opacity during dilated slitlamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;
Sites / Locations
- Eye Hospital, Wenzhou Medical UniversityRecruiting
- Beijing Tongren Hospital, Capital Medical University
- Peking University First Hospital
- The Second Xiangya Hospital of Central South University
- Ineye Hospital of Chengdu University of TCM
- Guang Zhou Aier eye Hospital
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- The Affiliated Hospital of Guizhou Medical University
- Henan Eye Hospital & Henan Institute
- The affiliated Hospital of Inner Mongolia Medical University
- Affiliated Eye Hospital, Shandong University of Traditional Chinese Medicine
- Shanghai Eye Disease Prevention and Treatment Center
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School Of Medicine
- Shanxi Eye Hospital
- West China Hospital, Sichuan University
- Tianjin Eye Hospital
- Tianjin Medical University Eye Hospital
- Wuhan Aier Eye Hospital
- Xi'An People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
LNZ101 (Aceclidine/Brimonidine) ophthalmic solution
LNZ100 (Aceclidine) ophthalmic solution
Placebo (Vehicle) ophthalmic solution
Aceclidine+Brimonidine combination ophthalmic solution
Aceclidine ophthalmic solution
Placebo (Vehicle) ophthalmic solution