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

Inclusion Criteria:

1. At Visit 1 (Screening Period), the age ranges from 45 to 75 years old, regardless ofgender

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) inthe clinical routine manifest refraction (distance vision).

3. At Visit 1 (Screening Period), the manifest refraction (distance vision undermesopic conditions) results are as follows: For any eye,-4.00D ≤ equivalentspherical 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:

5. Under mesopic conditions, monocular corrected near visual acuity (MCNVA) ≤65ETDRS letters (equivalent to decimal visual acuity 0.4) ;

6. Under mesopic conditions, monocular corrected near visual acuity with amultiple-pinhole occluder (MCNVA_P) improves by ≥15 ETDRS letters compared tomonocular corrected near visual acuity without the occluder (MCNVA).

7. During Visit 1 (Screening Period) and Visit 2, both eyes must meet the followingcriteria:under mesopic conditions, binocular corrected near visual acuity (BCNVA) is ≤65 ETDRS letters (equivalent to decimal visual acuity 0.4);

8. Any eye is phakic or implanted with a monofocal intraocular lens (IOL);

9. Normal iris and pupillary morphology in any eye, with normal light reflex and aninterocular pupillary diameter difference ≤1 mm during screening;

Exclusion Criteria:

1. Use of corneal or scleral contact lenses within 28 days prior to screening orplanned for the duration of the study;

2. Narrow anterior chamber angle (Van Herick grade ≤2 via slit lamp examination) orprevious iridotomy or resection in either eye；

3. Ocular history in any eye: hyphema, ciliary body detachment, iridodonesis, or oculartrauma；

4. Any eye with a corneal abnormality that, in the judgment of the investigator,affects visual acuity or intraocular pressure measurements, including moderate tosevere dry eye (e.g., significant signs of ocular surface damage (≥5 cornealfluorescein staining spots) on slit lamp microscopy);

5. Any phakic eye has a history of lens tremor, subluxation, or suspected zonularlaxity; or any pseudophakic eye has undergone posterior capsulotomy or usesmultifocal 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-complicatedcataract surgery with a monofocal lens placed in the capsular bag more than 6 monthsafter the date of surgery is permitted; complicated cataract surgery is defined assurgery that has resulted in a rupture of the capsule or placement of an IOL outsidethe capsule (ciliary sulcus, scleral or iris fixation, anterior chamber, etc.));

8. Either eye has a history of congenital or traumatic cataract, congenital aphakia, oropacities in the refractive media that affect visual acuity in the visual axis area.

9. History of uveitis, low intraocular pressure (IOP < 9 mmHg), glaucoma orhypertension (IOP > 21 mmHg) or pseudoexfoliation syndrome in either eye;

10. Active ocular or periocular infection or inflammation in either eye, or a history ofrecurrent infection or chronic infection (e.g., herpes virus infection) in eithereye;

11. Either eye has a history of retinal diseases (such as retinal detachment,age-related macular degeneration, diabetic retinopathy, peripheral retinal diseasesthat increase the risk of the subject as judged by the investigator) or optic nerveabnormalities.

12. During the screening period, any eye has any ocular disease other than presbyopiathat requires treatment with ocular preparations, intravitreal injection or ocularsurgery during the study period (except artificial tears, which can be used on theday of ocular examination during the screening period and on non-treatment visits).