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Completed

NCT Number: NCT03235115

Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses

This study aims to compare the short-term clinical performance of the three contact lenses (Methafilcon A IV, Ocufilcon B 1-day and Omafilcon A 1-day daily disposable).

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Key information

Age range

18 year–40 year

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 randomized, double-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Forty subjects will wear each lens brand for approximately one hour, on three separate study days in random order. Lenses will only be worn during study visits.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • They are of aged 18-40 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 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 (inclusive)
  • They have a spectacle cylindrical correction of -0.75D or less in each eye (based on the ocular refraction).
  • 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.

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 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, 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

Methafilcon A IV

Device

Contact Lens

Ocufilcon B

Device

Contact Lens

omafilcon A

Device

Contact Lens

Primary outcomes

  1. Visual Acuity Using logMAR

    Time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn

    Assessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction

  2. Lens Fit - Horizontal Centration

    Time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn

    Assessment of horizontal centration of lens on eye

  3. Lens Fit - Vertical Centration

    Time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn

    Assessment of vertical centration of lens on eye

  4. Lens Fit - Corneal Coverage of Lens

    Time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn

    Assessment of corneal coverage of lens on eye

  5. Lens Fit - Movement of Lens

    Time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn

    Assessment of movement of lens on eye

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 1, 2017
Registry last updated
Sep 12, 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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