The Clinical Performance of the Biofinity Contact Lens (Comfilcon A) With Two Lens Care Systems

Study Overview
=================
Brief Summary
-----------------
This will be a controlled and randomized, single-masked, crossover study in which 48 subjects will use the Biofinity Contact Lens (comfilcon A) with each of the two lens care products ('solutions'), (Synergi and Biotrue Multi-purpose Solution) for one month each. Follow-up visits for each solution will take place at one week, two weeks and four weeks: with a one-week 'wash-out' period between the solutions. Key outcome measures for this study include biomicroscopic and subjective responses to the lens/solution combinations.

Official Title
-----------------
The Clinical Performance of the Biofinity Contact Lens (Comfilcon A) With Two Lens Care Systems

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: comfilcon A
* Device: Synergi
* Device: Biotrue
* Other: stenfilcon A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: They are of legal age 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 have a contact lens spherical prescription between - 0.50 to - 6.00 (inclusive) They have a spectacle cylindrical correction of -1.00D (Diopters) or less in each eye. At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range. They currently use silicone hydrogel soft contact lenses. They are willing to comply with the wear schedule (at least 5 days per week, ≥8 hours/day). 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 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 lactating. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. 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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Synergi / comfilcon A<br>Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. | Device: comfilcon A<br>* soft contact lens<br>* Other names: Biofinity;Device: Synergi<br>* Multipurpose solution<br>Other: stenfilcon A<br>* daily disposable contact lenses for washout period<br>|
| Active Comparator: Biotrue / comfilcon A<br>Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. | Device: comfilcon A<br>* soft contact lens<br>* Other names: Biofinity;Device: Biotrue<br>* Multipurpose solution<br>Other: stenfilcon A<br>* daily disposable contact lenses for washout period<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival Hyperaemia | Conjunctival hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe. | Baseline, 1 week, 2 weeks, 4 weeks | 
| Limbal Hyperaemia | Limbal hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe. | Baseline, 1 week, 2 weeks, 4 weeks | 
| Corneal Staining | Corneal staining of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=none, 4=patch. | Baseline, 1 week, 2 weeks, 4 weeks | 
| Papillary Conjunctivitis | Papillary conjunctivitis of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe. | Baseline, 1 week, 2 weeks, 4 weeks | 
| Comfort | Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 1 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt. | 1 week | 
| Comfort | Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 2 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt. | 2 weeks | 
| Comfort | Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 4 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt. | 4 weeks | 
| Vision | Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision. | 1 week | 
| Vision | Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 2 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision. | 2 weeks | 
| Vision | Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 4 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision. | 4 weeks | 
| Dryness | Subjective assessment of dryness for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=extremely dry 100=not dry at all. | 1 week, 2 weeks, 4 weeks | 
| Burning/Stinging | Subjective assessment of burning/stinging for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=Extreme stinging / burning, 100=No stinging / burning sensation. | 1 week, 2 weeks, 4 weeks | 
| Ocular Redness | Subjective ocular redness of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=extremely poor. intolerable levels of redness, 100=excellent, no redness. | 1 week, 2 weeks, 4 weeks | 
| Ease of Lens Insertion | Subjective assessment of insertionfor Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to insert, 100=excellent. no problem with lens insertion. | 1 week, 2 weeks, 4 weeks | 
| Ease of Lens Removal | Subjective assessment of removal for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to remove, 100=excellent. no problem with lens remove. | 1 week, 2 weeks, 4 weeks | 
| Ease of Use of Solution | Subjective ease of use for Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=very difficult, 100=very easy | 1 week, 2 weeks, 4 weeks | 
| Overall Score | Subjective overall scores Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=extremely poor, 100=excellent, highly impressed. | 1 week, 2 weeks, 4 weeks |