Clinical trial NCT03632083: A Range of Contact Lenses and Care System Combinations
Official title: A Range of Contact Lenses and Care System Combinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Solutions
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2018-08-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a double-masked, randomized, contralateral, crossover study design. Lenses are worn as an unmatched pair.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

1. They are of legal age (18) 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 can be satisfactorily fitted with the study lens for a period of approximately 2 hours.
6. They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with their habitual spectacles.
7. They currently wear daily disposable soft contact lenses or have done so in the previous six months.
8. They are willing to comply with the wear schedule (approximately 2 hours on two different days)
9. They own a wearable pair of spectacles and agree to bring these to study visits.

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 currently wear reusable soft contact lenses in both eyes.
4. They are using any topical medication such as eye drops or ointment.
5. They have had cataract surgery.
6. They have had corneal refractive surgery.
7. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
8. They are pregnant or breast-feeding.
9. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
10. They have Type 2 or greater corneal staining prior to lens application at Visit 1 or 2
11. They have corneal staining covering greater than 20% in any corneal region at Visit 1a or 2a
12. 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.
13. 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: Biomicroscopy - Conjuctival Hyperaemia
timeFrame: Baseline (before lens insertion)
measure: Biomicroscopy - Conjuctival Hyperaemia
timeFrame: 2 hours
measure: Biomicroscopy - Limbal Hyperaemia
timeFrame: Baseline (before contact lens insertion)
measure: Biomicroscopy - Limbal Hyperaemia
timeFrame: 2 hours
measure: Biomicroscopy - Corneal Vascularisation
timeFrame: Baseline (before lens insertion)
measure: Biomicroscopy - Corneal Vascularisation
timeFrame: 2 hours
measure: Biomicroscopy - Microcysts
timeFrame: Baseline (before lens insertion)
measure: Biomicroscopy - Microcysts
timeFrame: 2 hours
measure: Biomicroscopy - Oedema
timeFrame: Baseline (before lens insertion)
measure: Biomicroscopy - Oedema
timeFrame: 2 hours
measure: Biomicroscopy - Conjunctival Staining
timeFrame: Baseline (before lens insertion)
measure: Biomicroscopy - Conjunctival Staining
timeFrame: 2 hours
measure: Biomicroscopy - Papillary Conjunctivitis
timeFrame: Baseline (before lens insertion)
measure: Biomicroscopy - Papillary Conjunctivitis
timeFrame: 2 hours
Secondary outcomes:
measure: Comfort
timeFrame: Baseline 5 minutes after lens insertion
measure: Comfort
timeFrame: 2 hours
measure: Dryness
timeFrame: 2 hours
measure: Overall Score
timeFrame: Baseline 5 minutes after lens insertion
measure: Overall Score
timeFrame: 2 hours
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research
Study officials:
affiliation: Eurolens Research
name: Philip Morgan, PhD MCOptom FAAO FBCLA
role: PRINCIPAL_INVESTIGATOR
References: