presbyopic
Conditions
Interventions
Test group: Ultra MF:Soft hydrophilic contact lens: Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, model and specification: Ultra Monthly Disposable Silicone hydrogel (sam
Control group: SLMF:Soft hydrophilic contact lens: SofLens MultiFocal (polymacon) Visibility Tinted Contact lens, model and specification: Soflens MultiFocal, SLMF
Sponsors
Eye Hospital, WMU, Zhejiang Eye Hospital
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Females or males who are 40 years old and above; 2) Patients with experience of soft contact lenses wear or experience of multifocal soft contact lenses operate; 3) Patients who sign informed consent voluntarily before the trial, and fully understand the content, process and possible adverse reactions of the trial; 4) Patients who have presbyopia with a near addition power range of +0.75 D (including +0.75 D) to +2.50 D (including +2.50 D) in each eye based on subjective refraction. 5) Patients who require distance lens correction with a power range of 0.00 D (including 0.00 D) to -7.75 D (including -7.75 D) in each eye based on subjective refraction; 6) Patients who are willing to wear soft hydrophilic contact in both eyes; 7) The best spectacle-corrected distance visual acuity is 5.0 in each eye.
Exclusion criteria
Exclusion criteria: 1) Patients who are receiving topical ophthalmic medication or any systemic medication that may interfere with contact lens wearing or require contact lens removal during the day time; 2) Subjective astigmatism: > 1.00 D in either eye; 3) Patients with any of the following eye conditions within 1 month prior to signing the ICF: ? Any active acute inflammation of the eye ? Moderate to severe dry eye (presence of multiple-quadrant corneal injury, or tear film break-up time (TBUT) 1.0 mm, etc. ? The slit lamp findings suggest other contraindications for wearing, such as corneal fluorescein staining > grade 2, etc.Patients who cannot wear the products under test at the discretion of the investigator; 4) Patients who have suffered or currently suffer from any of the following eye diseases: ? Chronic ocular inflammation such as: chronic keratitis, chronic uveitis, chronic dacryocystitis, chronic blepharitis, giant papillary conjunctivitis (GPC) = grade 2, iritis, etc. ? Other eye disorders: glaucoma, abnormal corneal perception, eyelid insufficiency, eyelid ptosis, dominant strabismus, cataract, keratoconus, etc. 5) Patients who has a systemic disease that may affect the eye, or who has a disease that may adversely affect the eye during the course of the study at the discretion of the investigator; 6) Density of corneal endothelium cells in the screening period: 21 mmHg or 5 mmHg in both eyes in the screening period; 8) Patients who are allergic to contact lens or related care products, or who have experienced serious adverse reactions after wearing contact lens; 9) Patients who underwent corneal operation before enrolled by this trial; 10) Patients who have worn rigid contact lens (including orthokeratology lens) within 30 days prior to signing the informed consent form; 11) Patients who have participated in other clinical trials of soft contact lens within 30 days or of rigid contact lens within 30 days prior to signing the informed consent, or who participated in drug clinical trials or other clinical trials at the same time within 3 months prior to signing the informed consent form; 12) Pregnant or lactating women; 13) Patients who live or work in environments unsuitable for wearing soft contact lens, for example, powders, medicines, aerosols (such as volatile chemicals), dust diffused in air, etc. 14) Patients who cannot wear soft hydrophilic contact lens as per requirement; 15) Patients who cannot take eye examination regularly; 16) Patients who do not have the necessary hygiene condition for wearing soft contact lens; 17) Patients who are considered unsuitable for participation in this study by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wearing effective rate after 1-week wearing; | — |
Secondary
| Measure | Time frame |
|---|---|
| Corrective vision of contact lenses;The best corrected visual acuity for frame mirrors;Subjective acceptability of contact lenses by subjects;Safety; | — |
Countries
China
Contacts
Public ContactJin Wanqing
Eye Hospital, WMU, Zhejiang Eye Hospital
Outcome results
None listed