A trial to assess the visual performance of multifocal contact lenses when worn by adults who have age-related problems with their focussing.

Not Applicable

Completed

• Conditions: Presbyopia; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12620001033932
• Lead Sponsor: Menicon Co. Ltd., Japan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-12
• Study Completion: 2021-06-04
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Age 40 and above, male or female.
Willing to comply with the clinical trial protocol as directed by the Investigator.
Agree not to participate in other clinical research for the duration of this clinical trial.
Have ocular health findings considered to be normal” and which would not prevent the participant from safely wearing contact lenses.
Contact lens wear experience in the past 5 years.
Best corrected spectacle acuity of at least 6/7.5.
Have no more than 1.00 D of astigmatism.
Can be fitted with multifocal soft contact lenses within the power range available.
Able to obtain a binocular contact lens high contrast visual acuity of at least 6/7.5 with study contact lenses.
Willing and able to wear each study contact lens for about one month on a daily wear basis, for at least 5 days per week and 7 hours per day.

Exclusion Criteria

Any pre-existing ocular irritation, injury, or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses.
Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, immunosuppressive disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome, and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
Corneal distortion resulting from previous hard or rigid lens wear or keratoconus.
Use of or a need for concurrent category S3 and above ocular medication at enrolment.
Eye surgery within 12 weeks immediately prior to enrolment for this trial.
Previous corneal refractive surgery or cataract surgery.
Contraindications to contact lens wear.
Known allergy or intolerance to ingredients in any of the clinical trial products.
Currently enrolled in another contact lens or lens care solution clinical trial within the last two weeks.
Currently wearing one of the contact lenses used in the study.
Pregnancy* or lactating at time of enrolment.
The Investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant’s best interests.
*Formal testing of pregnancy is not required. A participant’s verbal report is enough.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference between test and control lenses for subjective visual performance. Participants will be asked to rate their vision with each contact lens on a non-validated 1-100 numeric rating scale.[Visit 2 (approximately 1-month post enrolment - primary timepoint).<br>Visit 3 (approximately 2-months post enrolment - primary timepoint).<br>Visit 4 (approximately 3-months post enrolment - primary timepoint).<br>]