A Range of Contact Lenses and Care System Combinations

NCT03632083 | Completed Results DMC FDA Device

• 1 other identifier: C17-635 (EX-MKTG-95)
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Contact Lens Solutions

Outcome Measures

Primary Outcomes (14)

• Biomicroscopy - Conjuctival Hyperaemia

  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).

  Baseline (before lens insertion)

• Biomicroscopy - Conjuctival Hyperaemia

  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 hours

• Biomicroscopy - Limbal Hyperaemia

  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).

  Baseline (before contact lens insertion)

• Biomicroscopy - Limbal Hyperaemia

  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 hours

• Biomicroscopy - Corneal Vascularisation

  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).

  Baseline (before lens insertion)

• Biomicroscopy - Corneal Vascularisation

  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 hours

• Biomicroscopy - Microcysts

  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).

  Baseline (before lens insertion)

• Biomicroscopy - Microcysts

  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 hours

• Biomicroscopy - Oedema

  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).

  Baseline (before lens insertion)

• Biomicroscopy - Oedema

  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 hours

• Biomicroscopy - Conjunctival Staining

  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).

  Baseline (before lens insertion)

• Biomicroscopy - Conjunctival Staining

  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 hours

• Biomicroscopy - Papillary Conjunctivitis

  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).

  Baseline (before lens insertion)

• Biomicroscopy - Papillary Conjunctivitis

  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 hours

Secondary Outcomes (5)

• Comfort

  Baseline 5 minutes after lens insertion

• Comfort

  2 hours

• Dryness

  2 hours

• Overall Score

  Baseline 5 minutes after lens insertion

• Overall Score

  2 hours

Study Arms (2)

Hy-Care Contact Lens Solution

ACTIVE COMPARATOR

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; Device: fanfilcon A soft contact lens; Device: comfilcon A soft contact lens

Lite Contact Lens Solution

ACTIVE COMPARATOR

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; Device: fanfilcon A soft contact lens; Device: comfilcon A soft contact lens

Interventions

Hy-Care Contact Lens Solution DEVICE

Hy-Care Contact Lens Solution

Hy-Care Contact Lens Solution

Lite Contact Lens Solution DEVICE

Lite Contact Lens Solution

Lite Contact Lens Solution

fanfilcon A soft contact lens DEVICE

fanfilcon A soft contact lens

Hy-Care Contact Lens Solution; Lite Contact Lens Solution

comfilcon A soft contact lens DEVICE

comfilcon A soft contact lens

Hy-Care Contact Lens Solution; Lite Contact Lens Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Eurolens Research

Manchester, M13 9PL, United Kingdom

Location

Results Point of Contact

• Title: Jose A. Vega, O.D, MSc., FAAO
• Organization: CooperVision. Inc

javega@coopervision.com

9256213761

Study Officials

• Philip Morgan, PhD MCOptom FAAO FBCLA

  Eurolens Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a double-masked, randomized, contralateral, crossover study design. Lenses are worn as an unmatched pair.

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 15, 2018
• Study Start: September 12, 2018
• Primary Completion: October 23, 2018
• Study Completion: December 12, 2018
• Last Updated: August 24, 2020
• Results First Posted: August 24, 2020

Record last verified: 2020-08

Locations

GB (1)