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OpenTrials
Completed

NCT Number: NCT05633082

A Clinical Performance of Two Soft Toric Contact Lenses

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

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Key information

Conditions

Astigmatism Eye Diseases Refractive Errors

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

This participant-masked, non-randomized, controlled non-dispensing study was to compare the performance of two soft toric lenses. Participants attended one study visit which lasted for approximately 1.5 hours.

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 have ocular astigmatism in both eyes of between 0.75DC and 3.00DC.
  • 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 (omafilcon B)

Device

Toric daily wear contact lens for 15 minutes

Lens 2 (fanfilcon A)

Device

Toric daily wear contact lens for 15 minutes

Primary outcomes

  1. Subjective Overall Score

    Time frame: 15 minutes

    The subjective overall impression of the contact lens (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Extremely poor, 100=Excellent.

Secondary outcomes

  1. Subjective Comfort

    Time frame: 15 minutes

    Subjective comfort (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Causes pain,100=Excellent.

  2. Subjective Vision

    Time frame: 15 minutes

    Subjective vision (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Unacceptable,100=Excellent.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 1, 2022
Registry last updated
Nov 7, 2023

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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