Clinical trial NCT04067141: The Clinical Comparison of Somofilcon A 1 Day and Nelfilcon A Daily Disposable Contact Lenses
Official title: The Clinical Comparison of the Clariti 1 Day and DAILIES AquaComfort PLUS Daily Disposable Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2019-08-26
Enrollment: 70
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 bilateral crossover study
Primary purpose: OTHER

Brief 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.

Detailed description: This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross-comparison. This 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.

Subjects will use each lens type for a week in random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.

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.

Primary outcomes:
measure: Subjective Comfort at Lens Dispensing
timeFrame: Baseline (after 5 minutes of lens dispense)
measure: Subjective Comfort at Start of Day
timeFrame: 1 week
measure: Subjective Comfort at End of Day
timeFrame: 1 week
measure: Overall Subjective Comfort
timeFrame: Baseline (after 5 minutes of lens dispense)
measure: Overall Subjective Comfort
timeFrame: 1 week
measure: Subjective Vision
timeFrame: Baseline (after 5 minutes of lens dispense)
measure: Subjective Vision
timeFrame: 1 week
Secondary outcomes:
measure: Biomicroscopy - Conjunctival Redness Score
timeFrame: One Week
measure: Biomicroscopy - Limbal Redness Score
timeFrame: One week
measure: Biomicroscopy - Corneal Staining Score
timeFrame: One week
measure: Biomicroscopy - Conjunctival Staining Score
timeFrame: One week
measure: Biomicroscopy - Papillary Conjunctivitis Score
timeFrame: One week
measure: Horizontal Centration - Lens Fit
timeFrame: Baseline (after 5 minutes of lens dispense)
measure: Horizontal Centration - Lens Fit
timeFrame: One Week
measure: Vertical Centration Grade - Lens Fit
timeFrame: Baseline (after 5 minutes of lens dispense)
measure: Vertical Centration Grade - Lens Fit
timeFrame: One week
measure: Corneal Coverage Grade
timeFrame: Baseline (after 5 minutes of lens dispense)
measure: Corneal Coverage Grade
timeFrame: One week
measure: Post-Blink Movement Grade
timeFrame: Baseline (after 5 minutes of lens dispense)
measure: Post-Blink Movement Grade
timeFrame: 1 week
measure: Ocular Redness Rating
timeFrame: 1 week
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research
Study officials:
References: