Skip to main content
OpenTrials
Completed

NCT Number: NCT04536571

Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses

The principal hypothesis is to be tested in this work is that vision stability (the primary outcome measure) with a spherical contact lens correction vs. a toric contact lens correction will be the same.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Astigmatism Eye Diseases Myopia Refractive Errors

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurolens Research

Manchester, M13 9PL, United Kingdom

About this study

This will be a randomised, subject-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Thirty subjects will use each lens type at a single visit in random sequence.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • They are aged 18-35 years and have 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 are an existing wearer of soft spherical contact lenses in both eyes.
  • They have a spherical component of their spectacle refractive error between

-0.50DS and -6.50DS in both eyes.

  • They have a cylindrical component of their spectacle refractive error between

-0.75DC and -1.25DC in both eyes.

  • They can be fitted satisfactorily with both lens types.
  • They own an acceptable pair of spectacles.
  • They agree not to participate in other clinical research for the duration of the study.

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 (including comfort drops) or ointment on a regular basis.
  • 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 any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
  • They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
  • They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Treatment and study plan

TEST Contact Lens

Device

Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.

Other names: Soft comfilcon A toric contact lenses

CONTROL Contact Lens

Device

Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.

Other names: Soft comfilcon A sphere contact lenses

Primary outcomes

  1. Vision Stability While Doing Tasks on Mobile Phone

    Time frame: 30 minutes

    Vision stability was assessed by study subjects while doing tasks on mobile phone using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)

  2. Vision Stability While Doing Tasks on Desktop

    Time frame: 30 minutes

    Vision stability was assessed by study subjects while doing tasks on desktop using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)

  3. Vision Stability While Walking

    Time frame: 30 minutes

    Vision stability was assessed by study subjects while walking using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)

Secondary outcomes

  1. Lens Fit for Test Contact Lens

    Time frame: 10 minutes

    Lens fit was assessed for lens rotation after 10 minutes for toric fit. Lens mislocation from optimal position was measured in 0°, 1-5°, 6-10°, 11-15°, 16-20°, More than 20°.

  2. Lens Fit

    Time frame: 30 minutes

    Lens fit was assessed as either 'acceptable' or 'not acceptable' for standard fit by study investigator.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 2, 2020
Registry last updated
Nov 22, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.