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The Clinical Performance of the Biofinity Contact Lens (Comfilcon A) With Two Lens Care Systems

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ClinicalTrials.gov Identifier: NCT02510820
Recruitment Status : Completed
First Posted : July 29, 2015
Results First Posted : February 1, 2017
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:
This will be a controlled and randomized, single-masked, crossover study in which 48 subjects will use the Biofinity Contact Lens (comfilcon A) with each of the two lens care products ('solutions'), (Synergi and Biotrue Multi-purpose Solution) for one month each. Follow-up visits for each solution will take place at one week, two weeks and four weeks: with a one-week 'wash-out' period between the solutions. Key outcome measures for this study include biomicroscopic and subjective responses to the lens/solution combinations.

Condition or disease Intervention/treatment Phase
Myopia Device: comfilcon A Device: Synergi Device: Biotrue Other: stenfilcon A Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: The Clinical Performance of the Biofinity Contact Lens (Comfilcon A) With Two Lens Care Systems
Study Start Date : May 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Active Comparator: Synergi / comfilcon A
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
Device: comfilcon A
soft contact lens
Other Name: Biofinity

Device: Synergi
Multipurpose solution

Other: stenfilcon A
daily disposable contact lenses for washout period

Active Comparator: Biotrue / comfilcon A
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
Device: comfilcon A
soft contact lens
Other Name: Biofinity

Device: Biotrue
Multipurpose solution

Other: stenfilcon A
daily disposable contact lenses for washout period




Primary Outcome Measures :
  1. Conjunctival Hyperaemia [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks ]
    Conjunctival hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.

  2. Limbal Hyperaemia [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks ]
    Limbal hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.

  3. Corneal Staining [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks ]
    Corneal staining of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=none, 4=patch.

  4. Papillary Conjunctivitis [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks ]
    Papillary conjunctivitis of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.

  5. Comfort [ Time Frame: 1 week ]
    Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 1 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.

  6. Comfort [ Time Frame: 2 weeks ]
    Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 2 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.

  7. Comfort [ Time Frame: 4 weeks ]
    Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 4 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.

  8. Vision [ Time Frame: 1 week ]
    Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.

  9. Vision [ Time Frame: 2 weeks ]
    Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 2 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.

  10. Vision [ Time Frame: 4 weeks ]
    Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 4 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.

  11. Dryness [ Time Frame: 1 week, 2 weeks, 4 weeks ]
    Subjective assessment of dryness for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=extremely dry 100=not dry at all.

  12. Burning/Stinging [ Time Frame: 1 week, 2 weeks, 4 weeks ]
    Subjective assessment of burning/stinging for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=Extreme stinging / burning, 100=No stinging / burning sensation.

  13. Ocular Redness [ Time Frame: 1 week, 2 weeks, 4 weeks ]
    Subjective ocular redness of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=extremely poor. intolerable levels of redness, 100=excellent, no redness.

  14. Ease of Lens Insertion [ Time Frame: 1 week, 2 weeks, 4 weeks ]
    Subjective assessment of insertionfor Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to insert, 100=excellent. no problem with lens insertion.

  15. Ease of Lens Removal [ Time Frame: 1 week, 2 weeks, 4 weeks ]
    Subjective assessment of removal for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to remove, 100=excellent. no problem with lens remove.

  16. Ease of Use of Solution [ Time Frame: 1 week, 2 weeks, 4 weeks ]
    Subjective ease of use for Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=very difficult, 100=very easy

  17. Overall Score [ Time Frame: 1 week, 2 weeks, 4 weeks ]
    Subjective overall scores Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=extremely poor, 100=excellent, highly impressed.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. They are of legal age and capacity to volunteer.
  2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
  3. They are willing and able to follow the protocol.
  4. They agree not to participate in other clinical research for the duration of this study.
  5. They have a contact lens spherical prescription between - 0.50 to - 6.00 (inclusive)
  6. They have a spectacle cylindrical correction of -1.00D (Diopters) or less in each eye.
  7. 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.
  8. They currently use silicone hydrogel soft contact lenses.
  9. They are willing to comply with the wear schedule (at least 5 days per week, ≥8 hours/day).

Exclusion Criteria:

  1. They have an ocular disorder which would normally contra-indicate contact lens wear.
  2. They have a systemic disorder which would normally contra-indicate contact lens wear.
  3. They are using any topical medication such as eye drops or ointment.
  4. They have had cataract surgery.
  5. They have had corneal refractive surgery.
  6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  7. They are pregnant or lactating.
  8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
  9. 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.
  10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510820


Locations
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United Kingdom
Eurolens Research
Manchester, United Kingdom, M13 9PL
Sponsors and Collaborators
Coopervision, Inc.
Investigators
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Principal Investigator: Carole Maldonado-Codina University of Manchester

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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02510820     History of Changes
Other Study ID Numbers: EX-MKTG-54
First Posted: July 29, 2015    Key Record Dates
Results First Posted: February 1, 2017
Last Update Posted: February 1, 2017
Last Verified: January 2017