A Range of Contact Lenses and Care System Combinations
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Contact Lens Solutions
- Sponsor
- Coopervision, Inc.
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Biomicroscopy - Conjuctival Hyperaemia
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Biomicroscopy - Conjuctival Hyperaemia
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Comfort(2 hours)
- Dryness(2 hours)
- Overall Score(2 hours)