Evaluating eye drops for treating presbyopia in Chinese patients

A Multicenter, Randomized, Double-Blind, Crossover, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of BRIMOCHOL PF, CARBACHOL PF in Chinese Patients With Presbyopia

This study is testing two different eye drops to see if they can help Chinese patients with presbyopia see better.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 119 (estimated)
• Ages: 45 Years to 75 Years
• Sex: All
• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. (industry)
• Locations: 1 site (Wenzhou, Zhejiang)
• Trial ID: NCT06948357 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multicenter, randomized, double-blind, crossover, placebo-controlled Phase II study aimed at assessing the efficacy and safety of BRIMOCHOL PF and CARBACHOL PF eye drops in Chinese patients suffering from presbyopia. A total of 119 subjects will be enrolled and assigned to receive seven different treatments over a period of 30 days, with each treatment period lasting one day. The study includes a screening phase followed by a treatment phase, with multiple visits to monitor the participants' responses to the interventions.

Who should consider this trial

Good fit: Ideal candidates for this study are Chinese individuals aged 45 to 75 years with specific visual acuity criteria.

Not a fit: Patients with severe visual impairments or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective treatment options for presbyopia, improving the quality of life for patients affected by this condition.

How similar studies have performed: Other studies have shown promise in using similar ophthalmic solutions for treating presbyopia, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. At Visit 1 (Screening Period), the age ranges from 45 to 75 years old, regardless of gender
2. At Visit 1 (Screening Period), the corrected distance visual acuity of either eye is ≥ 0.8 (National Standard Logarithmic Visual Acuity Scale,decimal visual acuity) in the clinical routine manifest refraction (distance vision).
3. At Visit 1 (Screening Period), the manifest refraction (distance vision under mesopic conditions) results are as follows: For any eye,-4.00D ≤ equivalent spherical lens power ≤ +2.00D, and the negative cylinder lens power is ≥-2.00D;
4. At least one eye meeting the following at both Visit 1 and Visit 2:

   1. Under mesopic conditions, monocular corrected near visual acuity (MCNVA) ≤65 ETDRS letters (equivalent to decimal visual acuity 0.4) ;
   2. Under mesopic conditions, monocular corrected near visual acuity with a multiple-pinhole occluder (MCNVA\_P) improves by ≥15 ETDRS letters compared to monocular corrected near visual acuity without the occluder (MCNVA).
5. During Visit 1 (Screening Period) and Visit 2, both eyes must meet the following criteria:under mesopic conditions, binocular corrected near visual acuity (BCNVA) is ≤65 ETDRS letters (equivalent to decimal visual acuity 0.4);
6. Any eye is phakic or implanted with a monofocal intraocular lens (IOL);
7. Normal iris and pupillary morphology in any eye, with normal light reflex and an interocular pupillary diameter difference ≤1 mm during screening;

Exclusion Criteria:

1. Use of corneal or scleral contact lenses within 28 days prior to screening or planned for the duration of the study;
2. Narrow anterior chamber angle (Van Herick grade ≤2 via slit lamp examination) or previous iridotomy or resection in either eye；
3. Ocular history in any eye: hyphema, ciliary body detachment, iridodonesis, or ocular trauma；
4. Any eye with a corneal abnormality that, in the judgment of the investigator, affects visual acuity or intraocular pressure measurements, including moderate to severe dry eye (e.g., significant signs of ocular surface damage (≥5 corneal fluorescein staining spots) on slit lamp microscopy);
5. Any phakic eye has a history of lens tremor, subluxation, or suspected zonular laxity; or any pseudophakic eye has undergone posterior capsulotomy or uses multifocal or extended depth of focus intraocular lenses.
6. Any eye with an axial length of ≥26mm;
7. Either eye has undergone intraocular or corneal surgery (only non-complicated cataract surgery with a monofocal lens placed in the capsular bag more than 6 months after the date of surgery is permitted; complicated cataract surgery is defined as surgery that has resulted in a rupture of the capsule or placement of an IOL outside the capsule (ciliary sulcus, scleral or iris fixation, anterior chamber, etc.));
8. Either eye has a history of congenital or traumatic cataract, congenital aphakia, or opacities in the refractive media that affect visual acuity in the visual axis area.
9. History of uveitis, low intraocular pressure (IOP \< 9 mmHg), glaucoma or hypertension (IOP \> 21 mmHg) or pseudoexfoliation syndrome in either eye;
10. Active ocular or periocular infection or inflammation in either eye, or a history of recurrent infection or chronic infection (e.g., herpes virus infection) in either eye;
11. Either eye has a history of retinal diseases (such as retinal detachment, age-related macular degeneration, diabetic retinopathy, peripheral retinal diseases that increase the risk of the subject as judged by the investigator) or optic nerve abnormalities.
12. During the screening period, any eye has any ocular disease other than presbyopia that requires treatment with ocular preparations, intravitreal injection or ocular surgery during the study period (except artificial tears, which can be used on the day of ocular examination during the screening period and on non-treatment visits).

Where this trial is running

Wenzhou, Zhejiang

• Optometry Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (RECRUITING)

Study contacts

• Principal investigator: Jia Qu — Optometry Hospital of Wenzhou Medical University
• Study coordinator: Peiqiu Gu

Conditions: Presbyopia, presbyopia, eye drops, ophthalmic solution, Chinese, Brimochol, Carbachol, Brimonidine