A Clinical Comparison of Two Soft Multifocal Contact Lenses

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.

• Lens 1 (Device): Soft multifocal hydrogel contact lens for 15 minutes
• Lens 2 (Device): Soft multifocal silicone hydrogel contact lens for 15 minutes.

Primary outcomes

• Subjective Overall Score [15 Minutes]: Subjective Overall Score was assessed using the 0-100 visual analogue scale where 0=Extremely poor, cannot use lenses and 100=Excellent=Highly impressed with these lenses overall

Secondary outcomes

• Subjective Comfort [15 Minutes]: Subjective Comfort Score was assessed using the 0-100 visual analogue scale where 0=Extremely uncomfortable, causes pain, cannot be tolerated and 100=Excellent, cannot be felt
• Subjective Vision [15 Minutes]: Subjective Vision Score (distance and near) was assessed using the 0-100 visual analogue scale where 0=Unacceptable, cannot be worn and 100=Excellent, unaware of any visual loss

Sex: All, ages: 42 Years to any

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.

Participant flow

Outcome results

• Subjective Overall Score (Primary), Mean, score on a scale: Lens 1 71.4 +/- 18.0; Lens 2 80.3 +/- 14.7
• Subjective Comfort (Secondary), Mean, score on a scale: Lens 1 75.0 +/- 20.9; Lens 2 88.9 +/- 12.2
• Subjective Vision (Secondary), Mean, score on a scale: Lens 1 72.3 +/- 17.1; Lens 2 78.4 +/- 15.8

Adverse events

Time frame: Duration of the study, approximately 2.5 hours

• Study Protocol and Statistical Analysis Plan (PDF, 2023-01-13)

• Philip Morgan, PhD, MCOptom, Principal investigator, Eurolens Research