ACUVUE® OASYS MAX 1-day dispensing study

ACUVUE® OASYS MAX 1-day multifocal for astigmatism dispensing study

Registry ID
ISRCTN17278168
Source registry
ISRCTN
Status
Recruiting
Phase
PHASE4
Study type
INTERVENTIONAL
Sponsor
CooperVision International Limited
Enrollment
45
Start date
2026-07-17
Completion date
2026-09-01
Last update
2026-08-17

Conditions

Summary

Presbyopia & Astigmatism

Detailed description

The participants will attend the clinic for two study visits : At the first visit the participant will be fitted with the study contact lenses. A set of visual measurements and questionnaires will be carried out. At the end the visit 1 the participant will be dispensed with the study contact lenses to wear for 8 to 12 days and a follow up visit will scheduled. At visit 2 visual performance comfort and the vision satisfaction will be assessed by the investigators.

Interventions

Inclusion criteria

1. Age 40 years or greater 2. Have read and understood the participant Information Sheet 3. Have read, signed and dated the Informe Consent 4. Best corrected visual acuity of at least 20/25 in each eye 5. Have normal eyes with the exception of the need for visual correction 6. Current soft contact lenses wearer 7. Spectacle refraction: 7.1 Distance Sphere: −6.00 D to −0.50 D 7.2 Astigmatism (Cylinder): −0.75 D to −1.75 D 7.3 Axis: 10°, 20°, 30°, 70°, 80°, 90°, 100°, 110°, 150°, 160°, 170°, 180° 7.4 Near Addition: +0.75 D to +2.50 D 8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule

Exclusion criteria

1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear 2. Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, stimulants, anti-depressants, anti-psychotics, oral contraceptives) or new prescription eyedrops which is not rewetting/lubricating eyedrops for which contact lens wear could be contraindicated as determined by the investigatorMonocular participants (only one eye with functional vision) or participants fit with only one lens 3. Monocular participants (only one eye with functional vision) or participants fit with only one lens 4. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit 5. History of herpetic keratitis, ocular surgery or irregular cornea 6. Known pregnancy or lactation during the study period 7. Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals

Locations

Related clinical trials

View on source registry