A Clinical Comparison of Two Soft Multifocal Contact Lenses

CooperVision

Status: Completed

Conditions: Presbyopia

Treatments: Device: Lens 2; Device: Lens 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05794126

C22-726 (EX-MKTG-147)

Details and patient eligibility

About

The study objective was to gather short-term clinical performance data for two soft multifocal contact lenses.

Full description

The aim of this subject-masked, non-randomized, non-dispensing study was to evaluate the short-term clinical performance of a soft multifocal hydrogel contact lens when compared to a soft silicone multifocal hydrogel lens after 15 minutes of daily wear each.

Enrollment: 47 patients

Sex: All

Ages: 42+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. They were at least 42 years of age and had capacity to volunteer.
2. They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent.
3. They had had a full eye examination within the past two years (by self-report).
4. They were willing and able to follow the protocol.
5. They habitually used vision correction for near vision (multifocal soft contact lenses, sphere lenses for monovision, sphere lenses for distance vision correction and spectacles for near vision correction, or had a different spectacle prescription for distance and near vision correction) and had done so for at least the past three months.
6. They had refractive astigmatism of no greater than -0.75DC.
7. They could be fitted with the study lenses within the power range available, and achieved binocular distance HCVA of +0.20 or better in the study lenses.

Exclusion criteria

Subjects were not eligible to take part in the study if:

1. They had an ocular disorder which would normally contra-indicate contact lens wear.
2. They had a systemic disorder which would normally contra-indicate contact lens wear.
3. They were using any topical medication such as eye drops or ointment.
4. They were aphakic.
5. They had had corneal refractive surgery.
6. They had any corneal distortion resulting from previous hard or rigid lens wear or had keratoconus.
7. They were pregnant or lactating.
8. They had an eye or health condition including an immunosuppressive or infectious disease which could, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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47 participants in 2 patient groups

Lens 1

Experimental group

Description:

Participants wore Lens 1 for 15 minutes (Period 1)

Treatment:

Device: Lens 1

Lens 2

Experimental group

Description:

Participants wore Lens 2 for 15 minutes (Period 2)

Treatment:

Device: Lens 2