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Completed

NCT Number: NCT01965262

A Clinical Assessment of the Hemacopolymer Daily Disposable Limbal Ring Soft Contact Lens

This purpose of this study is to compare the clinical performance and subjective acceptance of two different daily disposable limbal ring lenses.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

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 is a subject-masked, dispensing study designed to evaluate the clinical performance and subjective acceptance when comparing two different daily disposable limbal ring lenses. Limbal ring lenses, which as well as correcting vision, have a colored ring which enhance the wearer's iris and are particularly popular in East Asian countries.

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 are 18 years of age and above.
  • 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 can attain at least 6/9 in each eye with the study lenses within the available power range.
  • They can be fitted with study lenses within the available power range.
  • The currently use soft contact lenses, or have done so within the last six months.

Exclusion criteria

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

  • They have an ocular disorder which would normally contraindicate contact lens wear.
  • They have a systemic disorder which would normally contraindicate 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 lactating.
  • 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 normally contraindicate contact lens wear, or may, in the opinion of the investigator, pose a risk to study personnel; or any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reactions.
  • They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Treatment and study plan

Hema-copolymer Lens

Device

contact lens

etafilcon A Lens

Device

contact lens

Primary outcomes

  1. Visual Acuity - Hema-copolymer and Etafilcon A

    Time frame: Baseline

    Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline.

  2. Visual Acuity - Hema-copolymer and Etafilcon A

    Time frame: 1 week

    Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week.

  3. Biomicroscopy - Hema-copolymer and Etafilcon A

    Time frame: 1 week

    Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe).

  4. Lens Surface - Deposition - Hema-copolymer and Etafilcon A

    Time frame: Baseline

    Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.

  5. Lens Surface - Deposition - Hema-copolymer and Etafilcon A

    Time frame: 1 week

    Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.

  6. Lens Surface - Debris - Hema-copolymer and Etafilcon A

    Time frame: Baseline

    Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.

  7. Lens Surface - Debris - Hema-copolymer and Etafilcon A

    Time frame: 1 week

    Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.

  8. Lens Surface - Wettability - Hema-copolymer and Etafilcon A

    Time frame: Baseline

    Lens surface of wettability for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.

  9. Lens Surface - Wettability - Hema-copolymer and Etafilcon A

    Time frame: 1 week

    Lens surface of wettability for hema-copolymer and etafilcon A pair lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.

  10. Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A

    Time frame: Baseline

    Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal

  11. Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A

    Time frame: 1 week

    Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal

  12. Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A

    Time frame: Baseline

    Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior

  13. Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A

    Time frame: 1 week

    Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior

  14. Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A

    Time frame: Baseline

    Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive

  15. Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A

    Time frame: 1 week

    Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive

  16. Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A

    Time frame: Baseline

    Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive

  17. Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A

    Time frame: 1 week

    Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive

  18. Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A

    Time frame: Baseline

    Subjective Assessment of comfort preference for hema-copolymer and etafilcon A assessed at baseline. Scale 0-100, 0=causes pain, 100= excellent.

  19. Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A

    Time frame: 1 week

    Subjective Assessment of comfort preference after insertion and before removal for hema-copolymer and etafilcon A lenses is assessed at 1 week. Scale 0-100, 0=causes pain, 100= excellent.

  20. Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A

    Time frame: Baseline

    Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.

  21. Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A

    Time frame: 1 week

    Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.

  22. Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A

    Time frame: Baseline

    Subjective Assessment of peripheral blur is assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.

  23. Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A

    Time frame: 1 week

    Subjective Assessment of peripheral blur assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.

  24. Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A

    Time frame: 1 week

    Subjective Assessment of ocular redness for hema-copolymer and etafilcon A lenses lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.

  25. Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A

    Time frame: 1 week

    Subjective Assessment of handling (ease of insertion and ease of removal) for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unmanageable, 100= excellent.

  26. Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A

    Time frame: Baseline

    Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.

  27. Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A

    Time frame: 1 week

    Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.

  28. Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A

    Time frame: Baseline

    Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.

  29. Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A

    Time frame: 1 week

    Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 18, 2013
Registry last updated
Mar 16, 2017

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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