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OpenTrials
Completed

NCT Number: NCT04067141

The Clinical Comparison of Somofilcon A 1 Day and Nelfilcon A Daily Disposable Contact Lenses

This subject-masked, randomized, bilateral crossover study will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis.

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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

This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross-comparison. This will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis.

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: 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 have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)
  • They have a maximum of -1.00DC ocular astigmatism in each eye.
  • They can be satisfactorily fitted with the study lens types.
  • At dispensing, they can attain at least 0.20 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).
  • They own a wearable pair of spectacles.

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 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.
  • They currently wear either the clariti 1day or the DAILIES AquaComfort Plus lens.

Treatment and study plan

somofilcon A

Device

Contact Lens

Other names: somofilcon A 1 day, test lens, clariti 1 day

Nelfilcon A

Device

Contact Lens

Other names: nelfilcon A Daily Disposable Contact Lens, control lens, DAILIES AquaComfort PLUS daily disposable

Primary outcomes

  1. Subjective Comfort at Lens Dispensing

    Time frame: Baseline (after 5 minutes of lens dispense)

    Subjective comfort at lens dispensing on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

  2. Subjective Comfort at Start of Day

    Time frame: 1 week

    Subjective comfort at start of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

  3. Subjective Comfort at End of Day

    Time frame: 1 week

    Subjective comfort at end of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

  4. Overall Subjective Comfort

    Time frame: Baseline (after 5 minutes of lens dispense)

    Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

  5. Overall Subjective Comfort

    Time frame: 1 week

    Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

  6. Subjective Vision

    Time frame: Baseline (after 5 minutes of lens dispense)

    Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)

  7. Subjective Vision

    Time frame: 1 week

    Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)

Secondary outcomes

  1. Biomicroscopy - Conjunctival Redness Score

    Time frame: One Week

    Conjunctival redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

  2. Biomicroscopy - Limbal Redness Score

    Time frame: One week

    Limbal redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

  3. Biomicroscopy - Corneal Staining Score

    Time frame: One week

    Corneal staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

  4. Biomicroscopy - Conjunctival Staining Score

    Time frame: One week

    Conjunctival staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

  5. Biomicroscopy - Papillary Conjunctivitis Score

    Time frame: One week

    Papillary conjunctivitis- slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

  6. Horizontal Centration - Lens Fit

    Time frame: Baseline (after 5 minutes of lens dispense)

    Horizontal centration graded by -2 to 2 (-2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal).

  7. Horizontal Centration - Lens Fit

    Time frame: One Week

    Horizontal centration graded by -2 to 2 (-2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal).

  8. Vertical Centration Grade - Lens Fit

    Time frame: Baseline (after 5 minutes of lens dispense)

    Vertical centration graded by -2 to 2 (-2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior).

  9. Vertical Centration Grade - Lens Fit

    Time frame: One week

    Vertical centration graded by -2 to 2 (-2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior).

  10. Corneal Coverage Grade

    Time frame: Baseline (after 5 minutes of lens dispense)

    Corneal coverage graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).

  11. Corneal Coverage Grade

    Time frame: One week

    Corneal coverage graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).

  12. Post-Blink Movement Grade

    Time frame: Baseline (after 5 minutes of lens dispense)

    Post-blink movement graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).

  13. Post-Blink Movement Grade

    Time frame: 1 week

    Post-blink movement graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).

  14. Ocular Redness Rating

    Time frame: 1 week

    Ocular redness rating rated on a scale 0-100 (0=extremely poor, intolerable levels of redness to 100 = excellent, no redness)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

The Clinical Comparison of the Clariti 1 Day and DAILIES AquaComfort PLUS Daily Disposable Contact Lenses

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 26, 2019
Registry last updated
Nov 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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