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Completed

NCT Number: NCT06758076

A Clinical Comparison of Two Soft Contact Lenses (C24-755)

The aim of this study is to compare the short-term clinical performance of two soft contact lenses.

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Key information

Conditions

Hyperopia Eye Diseases Myopia 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 study is to evaluate the short-term clinical performance of two soft contact lenses when compared to each other 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 breastfeeding.
  • 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 (ocufilcon D)

Device

15 minutes of daily wear

Lens 2 (somofilcon A)

Device

15 minutes of daily wear

Primary outcomes

  1. Subjective Overall Score

    Time frame: At the end of 15 minutes of daily wear

    The primary outcome measure for this study is the subjective overall score on a scale of 0-100 (0= Extremely poor, unmanageable, cannot use lenses, 100= Excellent, highly impressed with these lenses overall).

Secondary outcomes

  1. Subjective Vision

    Time frame: At the end of 15 minutes of daily wear

    The secondary outcome measure for this study is the subjective vision on a scale of 0-100 (0= Extremely poor, intolerable, lenses cannot be worn, 100= Excellent, unaware of any visual loss).

  2. Subjective Comfort

    Time frame: At the end of 15 minutes of daily wear

    The secondary outcome measure for this study is the subjective comfort on a scale of 0-100 (0= Extremely uncomfortable, causes pain, cannot be tolerated, 100= Excellent, cannot be felt).

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 3, 2025
Registry last updated
Jul 8, 2026

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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