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A Range of Contact Lenses and Care System Combinations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03632083
Recruitment Status : Completed
First Posted : August 15, 2018
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contact Lens Solutions Device: Hy-Care Contact Lens Solution Device: Lite Contact Lens Solution Device: fanfilcon A soft contact lens Device: comfilcon A soft contact lens Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a double-masked, randomized, contralateral, crossover study design. Lenses are worn as an unmatched pair.
Masking: Double (Participant, Investigator)
Masking Description: The first solution, the randomisation determines that the right lens will wear the fanfilcon A lens and the left eye will wear the comfilcon A lens for two hours of wear, with a two-day 'wash-out' period and the laterality of the lenses will be swapped for the second solution for two hours of wear. Lenses will be provided in lens cases which do not detail lens or care system information.
Primary Purpose: Basic Science
Official Title: A Range of Contact Lenses and Care System Combinations
Actual Study Start Date : September 12, 2018
Actual Primary Completion Date : October 23, 2018
Actual Study Completion Date : December 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Active Comparator: Hy-Care Contact Lens Solution
Each subject will 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. Patient will wear as an unmatched pair, per predetermined randomization schedule (to determine which eye receives fanfilcon A/comfilcon A lens).
Device: Hy-Care Contact Lens Solution
Hy-Care Contact Lens Solution

Device: fanfilcon A soft contact lens
fanfilcon A soft contact lens

Device: comfilcon A soft contact lens
comfilcon A soft contact lens

Active Comparator: Lite Contact Lens Solution
Each subject will 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 Lite contact lens solution. Patient will wear as an unmatched pair, per predetermined randomization schedule (to determine which eye receives fanfilcon A/comfilcon A lens).
Device: Lite Contact Lens Solution
Lite Contact Lens Solution

Device: fanfilcon A soft contact lens
fanfilcon A soft contact lens

Device: comfilcon A soft contact lens
comfilcon A soft contact lens




Primary Outcome Measures :
  1. Ocular Physiology [ Time Frame: Baseline visit, 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 Outcome Measures :
  1. Comfort [ Time Frame: After Insertion and Settling of Lens, 2 hours ]
    Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt).

  2. Dryness [ Time Frame: 2 hours ]
    Subjective ratings of dryness for each pair of lenses (scale: 0-100; 0=Intolerable levels of dryness, 100=No sensation of dryness).

  3. Overall Score [ Time Frame: After Insertion and Settling of Lens, 2 hours ]
    Subjective ratings of dryness for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. They are of legal age (18) 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 can be satisfactorily fitted with the study lens for a period of approximately 2 hours.
  6. They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with their habitual spectacles.
  7. They currently wear daily disposable soft contact lenses or have done so in the previous six months.
  8. They are willing to comply with the wear schedule (approximately 2 hours on two different days)
  9. They own a wearable pair of spectacles and agree to bring these to study visits.

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 currently wear reusable soft contact lenses in both eyes.
  4. They are using any topical medication such as eye drops or ointment.
  5. They have had cataract surgery.
  6. They have had corneal refractive surgery.
  7. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  8. They are pregnant or breast-feeding.
  9. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
  10. They have Type 2 or greater corneal staining prior to lens application at Visit 1 or 2
  11. They have corneal staining covering greater than 20% in any corneal region at Visit 1a or 2a
  12. 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.
  13. 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): NCT03632083


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: Philip Morgan, PhD MCOptom FAAO FBCLA Eurolens Research

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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT03632083    
Other Study ID Numbers: C17-635 (EX-MKTG-95)
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Contact Lens Solutions
Pharmaceutical Solutions
Disinfectants
Anti-Infective Agents