N/A Completed N=70 Randomized Single-blind Other

The Clinical Comparison of Somofilcon A 1 Day and Nelfilcon A Daily Disposable Contact Lenses

ametropia

Source: ClinicalTrials.gov NCT04067141 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2020

Primary outcomePrimary: Subjective Comfort at Lens Dispensing — 90.9; 88.5 units on a scale

Summary

This subject-masked, randomized, bilateral crossover study will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis.

Outcome Measures

Outcome	Result	p-value
PRIMARY Subjective Comfort at Lens Dispensing	90.9; 88.5	—
PRIMARY Subjective Comfort at Start of Day	89.9; 87.0	—
PRIMARY Subjective Comfort at End of Day	75.9; 68.0	—
PRIMARY Overall Subjective Comfort	86.1; 78.8	—
PRIMARY Overall Subjective Comfort	86.1; 78.8	—
PRIMARY Subjective Vision	90.9; 92.1	—
PRIMARY Subjective Vision	90.9; 92.1	—
SECONDARY Biomicroscopy - Conjunctival Redness Score	0.85; 0.87	—
SECONDARY Biomicroscopy - Limbal Redness Score	0.74; 0.79	—
SECONDARY Biomicroscopy - Corneal Staining Score	0.33; 0.32	—
SECONDARY Biomicroscopy - Conjunctival Staining Score	1.46; 0.35	—
SECONDARY Biomicroscopy - Papillary Conjunctivitis Score	1.02; 1.03	—
SECONDARY Horizontal Centration - Lens Fit	0; 0; 3; 1; 41; 57	—
SECONDARY Horizontal Centration - Lens Fit	0; 0; 3; 1; 41; 57	—
SECONDARY Vertical Centration Grade - Lens Fit	0; 0; 23; 50; 44; 44	—
SECONDARY Vertical Centration Grade - Lens Fit	0; 0; 23; 50; 44; 44	—
SECONDARY Corneal Coverage Grade	0; 1; 36; 26; 64; 71	—
SECONDARY Corneal Coverage Grade	0; 1; 36; 26; 64; 71	—
SECONDARY Post-Blink Movement Grade	0; 0; 21; 26; 67; 46	—
SECONDARY Post-Blink Movement Grade	0; 0; 21; 26; 67; 46	—
SECONDARY Ocular Redness Rating	94.1; 92.8	—

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 have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)
They have a maximum of -1.00DC ocular astigmatism in each eye.
They can be satisfactorily fitted with the study lens types.
At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
They currently use soft contact lenses or have done so in the previous six months.
They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
They own a wearable pair of spectacles.

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 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 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.
They currently wear either the clariti 1day or the DAILIES AquaComfort Plus lens.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04067141). 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.