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Completed

NCT Number: NCT04613882

Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses

The aim of this work is to undertake a range of vision-related measures with soft toric contact lenses soft spherical contact lenses and spectacle lens correction across a range of levels of astigmatism.

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Key information

Conditions

Astigmatism Eye Diseases Refractive Errors

Age range

18 year–40 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, crossover, partially subject-masked (for contact lenses only), non-dispensing study, controlled by cross-comparison.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

-

Subjects will only be eligible for the study if:

  • They are of legal age between 18 and 40 years.
  • 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 current wearers of any soft contact lens (i.e. have worn lenses in the last six months).
  • They have refractive ocular astigmatism between 0.00DC and -1.50DC in one or both eyes.
  • They have a spherical component to their ocular refractive error between 0.00 and - 6.00 DS.
  • They could attain at least 0.10 logMAR distance high contrast visual acuity in one eye with the study lenses within the available power range.
  • 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 this study.

Exclusion criteria

-

Subjects will not be eligible to take part in the study if:

  • 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 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 an amblyopic eye, in which case only dominant eye will be assessed for that subject.
  • They have an infectious disease (e.g. hepatitis), any immunosuppressive disease (e.g. HIV) or diabetes.
  • They have a history of severe allergic reaction or anaphylaxis.
  • They have taken part in any other contact lens clinical trial or research, within two weeks prior to starting this study.

Treatment and study plan

Soft Toric Custom Made Contact lens

Device

Subjects will be randomized to wear soft toric custom made lenses for 30 minutes in one eye with other eye patched.

Soft Spherical Contact Lenses

Device

Subjects will be randomized to wear soft spherical contact lenses for 30 minutes in one eye with other eye patched.

Spectacle Correction

Device

Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.

Primary outcomes

  1. Visual Acuity

    Time frame: Baseline with low contrast VA

    Visual acuity was assessed using logMAR for each intervention.

  2. Visual Acuity

    Time frame: After 30 minutes of dispense (Low Contrast VA)

    Visual acuity was assessed using logMAR for each intervention.

  3. Visual Acuity

    Time frame: Baseline with High contrast VA

    Visual acuity was assessed using logMAR for each intervention.

  4. Visual Acuity

    Time frame: After 30 minutes of dispense (High Contrast VA)

    Visual acuity was assessed using logMAR for each intervention.

Secondary outcomes

  1. Slit Lamp Biomicroscopy Findings - Conjunctival Redness

    Time frame: Entrance (Prior to wear of study lens)

    Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

    The assessments done were recorded prior to the first intervention.

    Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.

  2. Slit Lamp Biomicroscopy Findings - Conjunctival Redness

    Time frame: At Exit (After 30 minutes in each of three interventions)

    Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

    The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.

  3. Slit Lamp Biomicroscopy Findings - Limbal Redness

    Time frame: Entrance (Prior to wear of study lens)

    Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

    The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.

  4. Slit Lamp Biomicroscopy Findings - Limbal Redness

    Time frame: At Exit (After 30 minutes in each of three interventions)

    Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

    The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.

  5. Slit Lamp Biomicroscopy Findings - Corneal Staining

    Time frame: Entrance (Prior to wear of study lens)

    Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

    The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.

  6. Slit Lamp Biomicroscopy Findings - Corneal Staining

    Time frame: At Exit (After 30 minutes in each of three interventions)

    Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

    The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.

  7. Slit Lamp Biomicroscopy Findings - Conjunctival Staining

    Time frame: Entrance (Prior to wear of study lens)

    Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

    The assessments done were recorded prior to the first intervention.

    Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.

  8. Slit Lamp Biomicroscopy Findings - Conjunctival Staining

    Time frame: At Exit (After 30 minutes in each of three interventions)

    Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

    The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.

  9. Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis

    Time frame: Entrance (Prior to wear of study lens)

    Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

    The assessments done were recorded prior to the first intervention.

    Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.

  10. Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis

    Time frame: At Exit (After 30 minutes in each of three interventions)

    Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

    The assessments were done following the removal of the third intervention.

    Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.

  11. Slit Lamp Biomicroscopy Findings - Corneal Oedema

    Time frame: Entrance (Prior to wear of study lens)

    Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

    The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.

  12. Slit Lamp Biomicroscopy Findings - Corneal Oedema

    Time frame: At Exit (After 30 minutes in each of three interventions)

    Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

    The assessments were done following the removal of the third intervention.

    Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses Over a Range of Refractive Astigmatism

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2020
Registry last updated
Oct 11, 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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