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Completed

NCT Number: NCT06251154

Clinical Comparison of Two Soft Contact Lenses

This study was designed to gather short-term clinical performance data for 2 soft contact lenses.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurolens Research

Manchester, M13 9PL, United Kingdom

About this study

The purpose of this participant-masked, non-randomized, crossover controlled, non-dispensing, study was to compare the short-term performance of 2 daily disposable contact lenses after 15 minutes of daily wear each. The lenses were identical in all aspects except for diameter. Participants attended for 1 visit only which lasted for approximately 2 hours.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects will only be eligible for the study if:
  • They were of legal age (18) and capacity to volunteer.
  • They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent.
  • They were willing and able to follow the protocol.
  • They were wearing soft contact lenses, or had done so within the past two years.
  • They were able to be fitted with the study lenses within the power range available.

Exclusion criteria

  • Subjects will not be eligible 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.
  • They had 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

Device

Daily disposable silicone hydrogel contact lens (diameter=14.0mm) for 15 minutes

Lens 2

Device

Daily disposable silicone hydrogel contact lens (diameter=14.1mm) 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, unmanageable, 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=Extremely uncomfortable, 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=Extremely poor, intolerable, 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
2023
Primary completion
2024
Study completion
2024
First posted
Feb 9, 2024
Registry last updated
Aug 22, 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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