Phase
Condition
Presbyopia
Treatment
Aceclidine+Brimonidine combination ophthalmic solution
Aceclidine ophthalmic solution
Placebo (Vehicle) ophthalmic solution
Clinical Study ID
Ages 45-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be able and willing to provide written informed consent prior to any study procedurebeing 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 eyesdetermined by manifest refraction documented at Visit 1;
Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifestrefraction documented at Visit 1;
Have +1.00 D to -4.00 D manifest refraction spherical equivalent(MRSE)of Sphericalequivalent (SE) determined by manifest refraction documented at Visit 1.
Be presbyopic as determined at Visit 2 baseline
Exclusion
Exclusion Criteria:
Be a female of childbearing potential who is currently pregnant, nursing, orplanning a pregnancy;
Have known contraindications or sensitivity to the use of any of the studymedications or their components;
Have an active ocular infection at Visit 1 or at Visit 2 (bacterial, viral, orfungal), positive history of an ocular herpetic infection, preauricularlymphadenopathy, or ongoing, active ocular inflammation (e.g., moderate to severeblepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis,uveitis) in either eye;
Have moderate or severe dry eye at Visit 1, assessed by corneal fluoresceinstaining;
Have clinically significant abnormal lens findings (e.g., cataract) including earlylens changes and/or any evidence of a media opacity during dilated slitlampbiomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;
Study Design
Study Description
Connect with a study center
Eye Hospital, Wenzhou Medical University
Wenzhou, Zhejiang
ChinaSite Not Available
Beijing Tongren Hospital, Capital Medical University
Beijing,
ChinaSite Not Available
Peking University First Hospital
Beijing,
ChinaSite Not Available
The Second Xiangya Hospital of Central South University
Changsha,
ChinaSite Not Available
Ineye Hospital of Chengdu University of TCM
Chengdu,
ChinaSite Not Available
Dalian N0.3 people's hospital
Dalian,
ChinaSite Not Available
Guang Zhou Aier eye Hospital
Guangzhou,
ChinaSite Not Available
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou,
ChinaSite Not Available
The Affiliated Hospital of Guizhou Medical University
Guiyang,
ChinaSite Not Available
The Affiliated Hospital of Guizhou Medical University
Guizhou,
ChinaSite Not Available
Henan Eye Hospital & Henan Institute
Henan,
ChinaSite Not Available
The affiliated Hospital of Inner Mongolia Medical University
Hohhot,
ChinaSite Not Available
Affiliated Eye Hospital, Shandong University of Traditional Chinese Medicine
Jinan,
ChinaSite Not Available
Affiliated Eye Hospital, Shandong University of Traditional Chinese Medicine
Shandong,
ChinaSite Not Available
Shanghai Eye Disease Prevention and Treatment Center
Shanghai,
ChinaSite Not Available
Tongji Hospital Of Tongji University
Shanghai,
ChinaSite Not Available
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School Of Medicine
Shanghai,
ChinaSite Not Available
Shanxi Eye Hospital
Shanxi,
ChinaSite Not Available
West China Hospital, Sichuan University
Sichuan,
ChinaSite Not Available
Shanxi Eye Hospital
Taiyuan,
ChinaSite Not Available
Tianjin Eye Hospital
Tianjin,
ChinaSite Not Available
Tianjin Medical University Eye Hospital
Tianjin,
ChinaSite Not Available
Wuhan Aier Eye Hospital
Wuhan,
ChinaSite Not Available
Xi'An People's Hospital
Xi'an,
ChinaSite Not Available
Henan Eye Hospital & Henan Institute
Zhengzhou,
ChinaSite Not Available

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