Clinical trial NCT02510820: The Clinical Performance of the Biofinity Contact Lens (Comfilcon A) With Two Lens Care Systems
Official title: The Clinical Performance of the Biofinity Contact Lens (Comfilcon A) With Two Lens Care Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2015-07-29
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

1. They are of legal age 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 have a contact lens spherical prescription between - 0.50 to - 6.00 (inclusive)
6. They have a spectacle cylindrical correction of -1.00D (Diopters) or less in each eye.
7. 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.
8. They currently use silicone hydrogel soft contact lenses.
9. They are willing to comply with the wear schedule (at least 5 days per week, ≥8 hours/day).

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 are using any topical medication such as eye drops or ointment.
4. They have had cataract surgery.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. They are pregnant or lactating.
8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
9. 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.
10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Primary outcomes:
measure: Conjunctival Hyperaemia
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks
measure: Limbal Hyperaemia
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks
measure: Corneal Staining
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks
measure: Papillary Conjunctivitis
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks
measure: Comfort
timeFrame: 1 week
measure: Comfort
timeFrame: 2 weeks
measure: Comfort
timeFrame: 4 weeks
measure: Vision
timeFrame: 1 week
measure: Vision
timeFrame: 2 weeks
measure: Vision
timeFrame: 4 weeks
measure: Dryness
timeFrame: 1 week, 2 weeks, 4 weeks
measure: Burning/Stinging
timeFrame: 1 week, 2 weeks, 4 weeks
measure: Ocular Redness
timeFrame: 1 week, 2 weeks, 4 weeks
measure: Ease of Lens Insertion
timeFrame: 1 week, 2 weeks, 4 weeks
measure: Ease of Lens Removal
timeFrame: 1 week, 2 weeks, 4 weeks
measure: Ease of Use of Solution
timeFrame: 1 week, 2 weeks, 4 weeks
measure: Overall Score
timeFrame: 1 week, 2 weeks, 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research
Study officials:
affiliation: University of Manchester
name: Carole Maldonado-Codina
role: PRINCIPAL_INVESTIGATOR
References: