N/A N=56 Randomized Double-blind Basic Science

A Range of Contact Lenses and Care System Combinations

Contact Lens Solutions

Bottom Line

View on ClinicalTrials.gov: NCT03632083 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcome: Primary: Biomicroscopy - Conjuctival Hyperaemia — 0.95; 0.94; 0.91; 0.91 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Hy-Care Contact Lens Solution (Device); Lite Contact Lens Solution (Device); fanfilcon A soft contact lens (Device); comfilcon A soft contact lens (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: CooperVision, Inc.
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Biomicroscopy - Conjuctival Hyperaemia	1.01; 1.01; 0.99; 0.99	—
PRIMARY Biomicroscopy - Conjuctival Hyperaemia	1.01; 1.01; 0.99; 0.99	—
PRIMARY Biomicroscopy - Limbal Hyperaemia	0.90; 0.90; 0.81; 0.81	—
PRIMARY Biomicroscopy - Limbal Hyperaemia	0.90; 0.90; 0.81; 0.81	—
PRIMARY Biomicroscopy - Corneal Vascularisation	0.09; 0.09; 0.06; 0.05	—
PRIMARY Biomicroscopy - Corneal Vascularisation	0.09; 0.09; 0.06; 0.05	—
PRIMARY Biomicroscopy - Microcysts	0.00; 0.00; 0.00; 0.00	—
PRIMARY Biomicroscopy - Microcysts	0.00; 0.00; 0.00; 0.00	—
PRIMARY Biomicroscopy - Oedema	0.00; 0.00; 0.00; 0.00	—
PRIMARY Biomicroscopy - Oedema	0.00; 0.00; 0.00; 0.00	—
PRIMARY Biomicroscopy - Conjunctival Staining	1.00; 0.91; 1.16; 1.09	—
PRIMARY Biomicroscopy - Conjunctival Staining	1.00; 0.91; 1.16; 1.09	—
PRIMARY Biomicroscopy - Papillary Conjunctivitis	1.10; 1.08; 1.08; 1.07	—
PRIMARY Biomicroscopy - Papillary Conjunctivitis	1.10; 1.08; 1.08; 1.07	—
SECONDARY Comfort	90.5; 89.9; 92.3; 92.0	—
SECONDARY Comfort	90.5; 89.9; 92.3; 92.0	—
SECONDARY Dryness	92.6; 90.3; 91.5; 91.7	—
SECONDARY Overall Score	90.3; 89.1; 91.4; 87.1	—
SECONDARY Overall Score	90.3; 89.1; 91.4; 87.1	—

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.

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
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03632083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.