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OpenTrials
Completed

NCT Number: NCT03632083

A Range of Contact Lenses and Care System Combinations

The objective of this study is to compare the short-term clinical response to all combinations of two lens types: fanfilcon A and comfilcon A with two care systems: Hy-Care and Lite. The primary variables of interest are short-term biomicroscopy signs. Other variables of interest include subjective response and visual performance.

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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

Manchester, M13 9PL, United Kingdom

About this study

Subjects were randomized to wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Hy-Care contact lens solution and Lite contact lens solution.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 can be satisfactorily fitted with the study lens for a period of approximately 2 hours.
  • They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with their habitual spectacles.
  • They currently wear daily disposable soft contact lenses or have done so in the previous six months.
  • They are willing to comply with the wear schedule (approximately 2 hours on two different days)
  • They own a wearable pair of spectacles and agree to bring these to study visits.

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 currently wear reusable soft contact lenses in both eyes.
  • 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 Type 2 or greater corneal staining prior to lens application at Visit 1 or 2
  • They have corneal staining covering greater than 20% in any corneal region at Visit 1a or 2a
  • 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

Hy-Care Contact Lens Solution

Device

Hy-Care Contact Lens Solution

Lite Contact Lens Solution

Device

Lite Contact Lens Solution

fanfilcon A soft contact lens

Device

fanfilcon A soft contact lens

comfilcon A soft contact lens

Device

comfilcon A soft contact lens

Primary outcomes

  1. Biomicroscopy - Conjuctival Hyperaemia

    Time frame: Baseline (before lens insertion)

    Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

  2. Biomicroscopy - Conjuctival Hyperaemia

    Time frame: 2 hours

    Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

  3. Biomicroscopy - Limbal Hyperaemia

    Time frame: Baseline (before contact lens insertion)

    Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

  4. Biomicroscopy - Limbal Hyperaemia

    Time frame: 2 hours

    Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

  5. Biomicroscopy - Corneal Vascularisation

    Time frame: Baseline (before lens insertion)

    Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

  6. Biomicroscopy - Corneal Vascularisation

    Time frame: 2 hours

    Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

  7. Biomicroscopy - Microcysts

    Time frame: Baseline (before lens insertion)

    Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

  8. Biomicroscopy - Microcysts

    Time frame: 2 hours

    Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

  9. Biomicroscopy - Oedema

    Time frame: Baseline (before lens insertion)

    Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

  10. Biomicroscopy - Oedema

    Time frame: 2 hours

    Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

  11. Biomicroscopy - Conjunctival Staining

    Time frame: Baseline (before lens insertion)

    Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

  12. Biomicroscopy - Conjunctival Staining

    Time frame: 2 hours

    Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

  13. Biomicroscopy - Papillary Conjunctivitis

    Time frame: Baseline (before lens insertion)

    Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

  14. Biomicroscopy - Papillary Conjunctivitis

    Time frame: 2 hours

    Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

Secondary outcomes

  1. Comfort

    Time frame: Baseline 5 minutes after lens insertion

    Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt).

  2. Comfort

    Time frame: 2 hours

    Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt).

  3. Dryness

    Time frame: 2 hours

    Subjective ratings of dryness for each pair of lenses measured only at follow up (scale: 0-100; 0=Intolerable levels of dryness, 100=No sensation of dryness).

  4. Overall Score

    Time frame: Baseline 5 minutes after lens insertion

    Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall).

  5. Overall Score

    Time frame: 2 hours

    Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall).

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 15, 2018
Registry last updated
Aug 24, 2020

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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