A Range of Contact Lenses and Care System Combinations

• ClinicalTrials.gov Identifier: NCT03632083
• Recruitment Status: Completed
• First Posted: August 15, 2018
• Results First Posted: August 24, 2020
• Last Update Posted: August 24, 2020
• Sponsor: Coopervision, Inc.
• Information provided by (Responsible Party): Coopervision, Inc.

Study Description

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

Detailed Description:

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.

Study Design

• 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

Arms and Interventions

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.	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.	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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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).

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United Kingdom

Eurolens Research

Manchester, United Kingdom, M13 9PL

Sponsors and Collaborators

Coopervision, Inc.

Investigators

• Principal Investigator: Philip Morgan, PhD MCOptom FAAO FBCLA; Eurolens Research

  Study Documents (Full-Text)

Documents provided by Coopervision, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] June 18, 2018

More Information

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03632083
• Other Study ID Numbers: C17-635 (EX-MKTG-95)
• First Posted: August 15, 2018
• Results First Posted: August 24, 2020
• Last Update Posted: August 24, 2020
• Last Verified: August 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Contact Lens Solutions; Pharmaceutical Solutions; Disinfectants; Anti-Infective Agents