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OpenTrials
Completed

NCT Number: NCT02920983

A Clinical Comparison of Three Soft Daily Disposable Contact Lenses

This study aims to compare the clinical performance of the somfilcon A, nelfilcon A II 2 and omafilcon A II 2 daily disposable 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 - The University of Manchester

Manchester, M13 9PL, United Kingdom

About this study

This will be a randomised, subject-masked, crossover, bilateral study, controlled by cross comparison. Fifty subjects will use each lens type for a week in random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.

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 (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 agree not to participate in other clinical research for the duration of this study.
  • They have a contact lens spherical prescription between -1.00 to - 6.00D (Diopters) (inclusive)
  • They have a spectacle cylindrical correction of -0.75D or less in each eye.
  • At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
  • They currently use soft contact lenses or have done so in the previous six months.
  • They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).

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 cataract surgery.
  • 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 breast-feeding.
  • 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

somofilcon A

Device

contact lens

nelfilcon A II 2

Device

contact lens

omafilcon A ll 2

Device

contact lens

Primary outcomes

  1. Ocular Physiology

    Time frame: 1 week

    Ocular physiology assessment of by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

Secondary outcomes

  1. Lens Fit - Horizontal Centration

    Time frame: 1 week

    Horizontal centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.

  2. Lens Fit - Vertical Centration

    Time frame: 1 week

    Vertical centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.

  3. Lens Fit - Corneal Coverage

    Time frame: 1 week

    Corneal coverage will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.

  4. Lens Fit - Movement

    Time frame: 1 week

    Lens movement assessed using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.

  5. Lens Surface - Deposition

    Time frame: 1 week

    Lens surface will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe

  6. Lens Surface - Wettability

    Time frame: 1 week

    Lens wettability will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe

  7. Visual Acuity

    Time frame: 1 week

    Visual acuity will be assessed by LogMAR.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Sep 30, 2016
Registry last updated
Oct 17, 2019

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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