N/A Completed N=55 Randomized Double-blind Other

A Clinical Comparison of Two Daily Disposable Soft Contact Lenses

Source: ClinicalTrials.gov NCT04005885 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2020

Primary outcomePrimary: Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use — 89.9 units on a scale

Summary

This double-masked, randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses.

Outcome Measures

Outcome	Result	p-value
PRIMARY Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use	89.9	—
PRIMARY Subjective Scores of Comfort on Insertion	90.3; 90.4	—
SECONDARY Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use	83.7	—
SECONDARY Subjective Scores on Overall Comfort	84.0; 85.7	—
SECONDARY Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use	73.1	—
SECONDARY Subjective Scores on Comfort Before Removal	77.6; 79.3	—
SECONDARY Number of Participants With Horizontal Lens Centration Grade	0; 0; 3; 1; 20; 30	—
SECONDARY Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear	0; 1; 32; 21; 0	—
SECONDARY Number of Participants With Vertical Lens Centration Grade	0; 0; 10; 4; 22; 37	—
SECONDARY Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear	0; 9; 38; 7; 0	—
SECONDARY Number of Participants With Lens Corneal Coverage Grade	0; 0; 20; 3; 30; 43	—
SECONDARY Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear	0; 4; 43; 6; 1	—
SECONDARY Number of Participants With Post-Blink Movement Grade	0; 0; 5; 5; 34; 28	—
SECONDARY Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear	0; 6; 38; 10; 0	—
SECONDARY Investigator Lens Fit Acceptance	100; 100; 10; 21	—
SECONDARY Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use	98; 33	—

Eligibility Criteria

Inclusion Criteria

Subjects will only be eligible for the study if:
They are between 18 and 40 years of age (inclusive).
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 are an existing soft reusable spherical contact lens wearer in both eyes.
They have a contact lens spherical prescription between -0.50 to -6.00D (inclusive) based on the ocular refraction.
They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction
They own a wearable pair of spectacles and wear them on the day of the initial visit.
They have distance high contrast logMAR visual acuity of 0.2 or better in each eye with their habitual spectacles.
They agree not to participate in other clinical research for the duration of the study.

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 are using any topical medication such as eye drops or ointment.
They are aphakic.
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 breastfeeding.
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 (NCT04005885). 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. Informational only — not medical advice.