Actively Recruiting
Efficacy and Safety of BRIMOCHOL PF and CARBACHOL PF in Chinese Presbyopia Patients
Led by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · Updated on 2025-04-29
119
Participants Needed
1
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multicenter, randomized, double-Blind, crossover, placebo-controlled Phase II clinical Study to evaluate the efficacy and safety of BRIMOCHOL PF and CARBACHOL PF in the treatment of Chinese patients with presbyopia.
CONDITIONS
Official Title
Efficacy and Safety of BRIMOCHOL PF and CARBACHOL PF in Chinese Presbyopia Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 45 and 75 years at screening
- Corrected distance visual acuity in either eye of at least 0.8 (decimal visual acuity)
- Manifest refraction in any eye with spherical lens power between -4.00D and +2.00D and cylinder lens power of -2.00D or greater
- At least one eye with monocular corrected near visual acuity of 65 ETDRS letters or better under mesopic conditions and improvement of 15 ETDRS letters with a multiple-pinhole occluder
- Both eyes with binocular corrected near visual acuity of 65 ETDRS letters or better under mesopic conditions
- Eyes are phakic or have a monofocal intraocular lens implanted
- Normal iris and pupil shape with normal light reflex and interocular pupil diameter difference no greater than 1 mm at screening
You will not qualify if you...
- Use of corneal or scleral contact lenses within 28 days before screening or planned use during the study
- Narrow anterior chamber angle (Van Herick grade 2 or less) or previous iridotomy or resection in either eye
- History of hyphema, ciliary body detachment, iridodonesis, or ocular trauma in either eye
- Corneal abnormalities affecting vision or intraocular pressure measurements, including moderate to severe dry eye
- History of lens tremor, subluxation, or zonular laxity in phakic eyes; prior posterior capsulotomy or multifocal/extended depth of focus lenses in pseudophakic eyes
- Axial length of any eye greater than or equal to 26 mm
- Previous intraocular or corneal surgery except uncomplicated cataract surgery with monofocal lens more than 6 months prior
- History of congenital or traumatic cataract, congenital aphakia, or significant refractive media opacities
- History of uveitis, low or high intraocular pressure, glaucoma, hypertension, or pseudoexfoliation syndrome
- Active or recurrent ocular or periocular infection or inflammation
- History of retinal diseases or optic nerve abnormalities
- Any ocular disease other than presbyopia requiring treatment or surgery during the study (except artificial tears on non-treatment days)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Optometry Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Actively Recruiting
Research Team
P
Peiqiu Gu
CONTACT
X
Xiaochen Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
7
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here