Efficacy and Safety of BRIMOCHOL PF and CARBACHOL PF in Chinese Presbyopia Patients

Official title

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

Overview

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.

Detailed description

119 subjects were planned to be enrolled in this study and randomly assigned in equal proportions into 7 treatment sequences. Each subject will receive a total of 7 treatments, each treatment period will be 1 day, and two adjacent visits during the treatment period need to be eluted for at least 3 days。

The study period included the screening period (Day 14\~Day 1) with 1 visit and the treatment period (Day 0\~Day 30) with 7 visits. There were a total of 8 visits in this study, with a duration of 32 to 45 days.

Interventions

• Drug BRIMOCHOL PF eye drops; CARBACHOL PF eye drops; Brimonidine eye drops; Placebo
  BRIMOCHOL PF eye drops, CARBACHOL PF eye drops, Brimonidine eye drops and Placebo were administered in 7 treatment sequences in various combinations and doses

Primary outcome measures

• Changes in MCNVA(monocular corrected near visual acuity) ETDRS letters and MCDVA (monocular corrected distance visual acuity) ETDRS letters from baseline in the study eyes after administration [Time frame: 15minutes, 1hour, 2hour, 4hour15minutes, 6hour, and 8hour after administration]

Secondary outcome measures (5)

• Changes in MCNVA(monocular corrected near visual acuity) ETDRS letters from baseline in the study eyes after administration [Time frame: 15minutes, 1hour, 2hour, 4hour15minutes, 6hour, and 8hour after administration]
• Changes in MCNVA(monocular corrected near visual acuity) ETDRS letters from baseline in the study eyes after administration [Time frame: 15 minutes to 8 hours after administration]
• Changes in MCNVA(monocular corrected near visual acuity) ETDRS letters from baseline in the study eyes after administration [Time frame: 15 minutes to 8 hours after administration]
• Changes in BCNVA (Binocular Corrected Near Visual Acuity) ETDRS letters and BCDVA (Binocular Corrected Distance Visual Acuity) ETDRS letters from baseline after administration [Time frame: 15minutes, 1hour, 2hour, 4hour15minutes, 6hour, and 8hour after administration]
• Changes in pupil diameter from baseline after administration [Time frame: 15minutes, 1hour, 2hour, 4hour15minutes, 6hour, and 8hour after administration]

Eligibility criteria

Inclusion criteria

• At Visit 1 (Screening Period), the age ranges from 45 to 75 years old, regardless of gender
• 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).
• 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;
• At least one eye meeting the following at both Visit 1 and Visit 2:

• Under mesopic conditions, monocular corrected near visual acuity (MCNVA) ≤65 ETDRS letters (equivalent to decimal visual acuity 0.4) ;
• 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).
• 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);
• Any eye is phakic or implanted with a monofocal intraocular lens (IOL);
• Normal iris and pupillary morphology in any eye, with normal light reflex and an interocular pupillary diameter difference ≤1 mm during screening;

Exclusion criteria

• Use of corneal or scleral contact lenses within 28 days prior to screening or planned for the duration of the study;
• Narrow anterior chamber angle (Van Herick grade ≤2 via slit lamp examination) or previous iridotomy or resection in either eye；
• Ocular history in any eye: hyphema, ciliary body detachment, iridodonesis, or ocular trauma；
• 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);
• 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.
• Any eye with an axial length of ≥26mm;
• 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.));
• 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.
• History of uveitis, low intraocular pressure (IOP < 9 mmHg), glaucoma or hypertension (IOP > 21 mmHg) or pseudoexfoliation syndrome in either eye;
• 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;
• 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.
• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Optometry Hospital of Wenzhou Medical University — Wenzhou

Identifiers

NCT: NCT06948357 · ZKO-CSP-BRI-CAR-201

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗