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OpenTrials
Completed

NCT Number: NCT05794126

A Clinical Comparison of Two Soft Multifocal Contact Lenses

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

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Key information

Age range

42 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Manchester

Manchester, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • They were at least 42 years of age and had capacity to volunteer.
  • They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent.
  • They had had a full eye examination within the past two years (by self-report).
  • They were willing and able to follow the protocol.
  • 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.
  • They had refractive astigmatism of no greater than -0.75DC.
  • 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:

  • They had an ocular disorder which would normally contra-indicate contact lens wear.
  • They had a systemic disorder which would normally contra-indicate contact lens wear.
  • They were using any topical medication such as eye drops or ointment.
  • They were aphakic.
  • They had had corneal refractive surgery.
  • They had any corneal distortion resulting from previous hard or rigid lens wear or had keratoconus.
  • They were pregnant or lactating.
  • 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.

Treatment and study plan

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

  1. Subjective Overall Score

    Time frame: 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

  1. Subjective Comfort

    Time frame: 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

  2. Subjective Vision

    Time frame: 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

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 3, 2023
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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