A Range of Contact Lenses and Care System Combinations

Not Applicable

Completed

• Conditions: Contact Lens Solutions
• Interventions: Device: Lite Contact Lens Solution; Device: Hy-Care Contact Lens Solution; Device: fanfilcon A soft contact lens; Device: comfilcon A soft contact lens

• Registration Number: NCT03632083
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-15
• Study Start: 2018-09-12
• Primary Completion: 2018-10-23
• Study Completion: 2018-12-12
• Results First Submitted: 2020-07-13
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-11
• Last Update Submitted: 2020-08-11
• Results First Posted: 2020-08-24
• Last Update Posted: 2020-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lite Contact Lens Solution	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.
Hy-Care Contact Lens Solution	fanfilcon A soft contact lens	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.
Hy-Care Contact Lens Solution	comfilcon A soft contact lens	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.
Lite Contact Lens Solution	fanfilcon A soft contact lens	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.
Hy-Care Contact Lens Solution	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.
Lite Contact Lens Solution	comfilcon A soft contact lens	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.

Primary Outcome Measures

Name	Time	Method
Biomicroscopy - Conjuctival Hyperaemia	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).
Biomicroscopy - Limbal Hyperaemia	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).
Biomicroscopy - Oedema	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).
Biomicroscopy - Papillary Conjunctivitis	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).
Biomicroscopy - Corneal Vascularisation	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).
Biomicroscopy - Conjunctival Staining	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).
Biomicroscopy - Microcysts	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

Name	Time	Method
Comfort	2 hours	Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt).
Dryness	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).
Overall Score	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).

Trial Locations

Locations (1)

Eurolens Research; 🇬🇧 Manchester, United Kingdom