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Completed

NCT Number: NCT05741450

A Clinical Comparison of Two Soft Contact Lenses

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

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Key information

Conditions

Myopia Eye Diseases Hyperopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurolens Research

Manchester, United Kingdom

About this study

The aim of this subject-masked, non-randomized, controlled non-dispensing study was to evaluate the short-term clinical performance of a monthly sphere contact lens when compared to a daily disposable contact 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 are of legal age (18) and capacity to volunteer.
  • They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
  • They are willing and able to follow the protocol.
  • They currently wear soft contact lenses, or have done so within the past two years.
  • They are expected to be able to be fitted with the study lenses within the power range available.

Exclusion criteria

  • They have an ocular disorder which would normally contra-indicate contact lens wear.
  • They have a systemic disorder which would normally contra-indicate contact lens wear.
  • They are using any topical medication such as eye drops or ointment.
  • They are aphakic.
  • They have had corneal refractive surgery.
  • They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  • They are pregnant or lactating.
  • They have an eye or health condition including an immunosuppressive or infectious disease which would, 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.
  • They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Treatment and study plan

Lens 1 (monthly replacement)

Device

Monthly replacement spherical silicone hydrogel contact lens for 15 minutes

Lens 2 (daily disposable)

Device

Daily disposable spherical silicone hydrogel contact lens for 15 minutes

Primary outcomes

  1. Subjective Overall Score

    Time frame: 15 minutes

    Subjective overall score was assessed using 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 0-100 visual analogue scale, where 0=Causes pain, cannot be tolerated and 100=Excellent, cannot be felt

  2. Subjective Vision

    Time frame: 15 minutes

    Subjective vision score was assessed using a 0-100 visual analogue scale, where 0=Unacceptable, lens cannot be worn and 100=Excellent, unaware of any visual loss

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

A Clinical Comparison of Two Soft Contact Lenses (Iteration Under Umbrella Protocol C19-678)

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2023
Registry last updated
Jan 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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