Actively Recruiting
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 Chinese Patients With Presbyopia
Led by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · Updated on 2025-04-29
119
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of BRIMOCHOL PF and CARBACHOL PF eye drops in treating presbyopia in Chinese patients. This Phase II, multicenter, randomized, double-blind, placebo-controlled study involves 119 participants aged 45 to 75 years. The study uses a crossover design to compare these treatments with placebo and brimonidine eye drops, aiming to improve near and distance visual acuity. Participants will be randomly assigned to one of seven treatment sequences. Each participant will receive seven different treatments over separate visits, including single and twice dosing of BRIMOCHOL PF, CARBACHOL PF, brimonidine, and placebo eye drops. The treatment periods last one day each, with at least three days between treatments. The study includes a screening period followed by a treatment period with a total of eight visits over 32 to 45 days. During the study, participants will undergo vision tests to measure changes in monocular and binocular corrected near and distance visual acuity at various time points after eye drop administration. Researchers will also assess changes in pupil diameter. The study monitors safety and efficacy through scheduled visits, with the primary outcome focusing on visual acuity changes up to eight hours after treatment.
CONDITIONS
Brief 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 of either eye is 0.8 or better
- Manifest refraction (distance vision under mesopic conditions) with equivalent spherical lens power between -4.00D and +2.00D, and negative cylinder lens power 6-2.00D
- At least one eye with monocular corrected near visual acuity (MCNVA) 65 ETDRS letters or worse under mesopic conditions
- MCNVA with multiple-pinhole occluder improves by at least 15 ETDRS letters compared to MCNVA without occluder
- Both eyes with binocular corrected near visual acuity (BCNVA) 65 ETDRS letters or worse under mesopic conditions
- Any eye is phakic or has a monofocal intraocular lens implanted
- Normal iris and pupil shape with normal light reflex and interocular pupil diameter difference of 1 mm or less during screening
You will not qualify if you...
- Use of corneal or scleral contact lenses within 28 days prior to screening or planned 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 measurement, including moderate to severe dry eye
- History of lens tremor, subluxation, or suspected zonular laxity in any phakic eye
- Use of multifocal or extended depth of focus intraocular lenses or posterior capsulotomy in pseudophakic eyes
- Axial length of any eye of 26 mm or more
- Intraocular or corneal surgery in either eye except uncomplicated cataract surgery with monofocal lens more than 6 months prior
- History of congenital or traumatic cataract, congenital aphakia, or visual axis opacities affecting vision
- History of uveitis, low or high intraocular pressure, glaucoma, or pseudoexfoliation syndrome in either eye
- Active or recurrent ocular or periocular infection or inflammation
- History of retinal diseases or optic nerve abnormalities
- Ocular disease other than presbyopia requiring treatment during the study period, except use of artificial tears on non-treatment days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 month
Participants receive 7 different study eye drop treatments in a randomized crossover design with at least 3 days between treatments.
7 visits (in-person) during treatment period
Trial Site Locations
Total: 1 location
1
Optometry Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Actively Recruiting
Research Team
P
Peiqiu Gu
X
Xiaochen Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
7
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