A Range of Contact Lenses and Care System Combinations

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Range of Contact Lenses and Care System Combinations

Conditions
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Contact Lens Solutions

Intervention / Treatment
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* Device: Hy-Care Contact Lens Solution
* Device: Lite Contact Lens Solution
* Device: fanfilcon A soft contact lens
* Device: comfilcon A soft contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a double-masked, randomized, contralateral, crossover study design. Lenses are worn as an unmatched pair.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hy-Care Contact Lens Solution<br>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<br>* Hy-Care Contact Lens Solution<br>Device: fanfilcon A soft contact lens<br>* fanfilcon A soft contact lens<br>Device: comfilcon A soft contact lens<br>* comfilcon A soft contact lens<br>|
| Active Comparator: Lite Contact Lens Solution<br>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<br>* Lite Contact Lens Solution<br>Device: fanfilcon A soft contact lens<br>* fanfilcon A soft contact lens<br>Device: comfilcon A soft contact lens<br>* comfilcon A soft contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort | Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt). | Baseline 5 minutes after lens insertion | 
| Comfort | Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt). | 2 hours | 
| Dryness | 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). | 2 hours | 
| Overall Score | Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall). | Baseline 5 minutes after lens insertion | 
| Overall Score | Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall). | 2 hours |