A Range of Contact Lenses and Care System Combinations

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03632083

Enrollment

Registered

2018-08-15

Start date

2018-09-12

Completion date

2018-12-12

Last updated

2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contact Lens Solutions

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.

Interventions

DEVICEHy-Care Contact Lens Solution

Hy-Care Contact Lens Solution

DEVICELite Contact Lens Solution

Lite Contact Lens Solution

DEVICEfanfilcon A soft contact lens

fanfilcon A soft contact lens

DEVICEcomfilcon A soft contact lens

comfilcon A soft contact lens

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Masking description

The first solution, the randomisation determines that the right lens will wear the fanfilcon A lens and the left eye will wear the comfilcon A lens for two hours of wear, with a two-day 'wash-out' period and the laterality of the lenses will be swapped for the second solution for two hours of wear. Lenses will be provided in lens cases which do not detail lens or care system information.

Intervention model description

This is a double-masked, randomized, contralateral, crossover study design. Lenses are worn as an unmatched pair.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Biomicroscopy - Papillary Conjunctivitis	Baseline (before lens insertion)	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	Baseline (before lens insertion)	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	Baseline (before lens insertion)	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	Baseline (before lens insertion)	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 - Conjuctival Hyperaemia	Baseline (before lens insertion)	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	Baseline (before contact lens insertion)	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	Baseline (before lens insertion)	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

Measure	Time frame	Description
Dryness	2 hours	Subjective ratings of dryness for each pair of lenses measured only at follow up (scale: 0-100; 0=Intolerable levels of dryness, 100=No sensation of dryness).
Overall Score	Baseline 5 minutes after lens insertion	Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall).
Comfort	Baseline 5 minutes after lens insertion	Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt).

Countries

United Kingdom

Participant flow

Pre-assignment details

This was a randomised, double-masked, contralateral, cross-over study in which 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 a lens care product Lite or Hy-Care.

Participants by arm

Arm	Count
Overall Participants 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. Contact Lens Solution: Hy-Care Contact Lens Solution Contact Lens Solution: Lite contact lens solution	28
Total	28

Baseline characteristics

Characteristic	Overall Participants	—
Age, Categorical <=18 years	0 Participants	—
Age, Categorical >=65 years	0 Participants	—
Age, Categorical Between 18 and 65 years	28 Participants	—
Age, Continuous	38.9 years STANDARD_DEVIATION 16.2	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment United Kingdom	28 participants	—
Sex: Female, Male Female	16 Participants	—
Sex: Female, Male Male	12 Participants	—

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 28	0 / 28	0 / 28	0 / 28
other Total, other adverse events	0 / 28	0 / 28	0 / 28	0 / 28
serious Total, serious adverse events	0 / 28	0 / 28	0 / 28	0 / 28