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

The Clinical Comparison of the Clariti 1 Day and DAILIES AquaComfort PLUS Daily Disposable Contact Lenses

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.

Study Overview

• Status: Completed
• Conditions: Ametropia
• Intervention / Treatment: Device: somofilcon A; Device: nelfilcon A

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9PL
    • Eurolens Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: somofilcon A, then nelfilcon A; Subjects will bilaterally wear the somofilcon A lenses, then crossover to nelfilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week.	Device: somofilcon A; Contact Lens; Other Names: test lens; somofilcon A 1 day; clariti 1 day; Device: nelfilcon A; Contact Lens; Other Names: control lens; nelfilcon A Daily Disposable Contact Lens; DAILIES AquaComfort PLUS daily disposable
Experimental: nelfilcon A, then somofilcon A; Subjects will bilaterally wear the nelfilcon A lenses, then crossover to somofilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week.	Device: somofilcon A; Contact Lens; Other Names: test lens; somofilcon A 1 day; clariti 1 day; Device: nelfilcon A; Contact Lens; Other Names: control lens; nelfilcon A Daily Disposable Contact Lens; DAILIES AquaComfort PLUS daily disposable

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Comfort at Lens Dispensing	Subjective comfort at lens dispensing on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).	Baseline (after 5 minutes of lens dispense)
Subjective Comfort at Start of Day	Subjective comfort at start of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).	1 week
Subjective Comfort at End of Day	Subjective comfort at end of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).	1 week
Overall Subjective Comfort	Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).	Baseline (after 5 minutes of lens dispense)
Overall Subjective Comfort	Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).	1 week
Subjective Vision	Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)	Baseline (after 5 minutes of lens dispense)
Subjective Vision	Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomicroscopy - Conjunctival Redness Score	Conjunctival redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).	One Week
Biomicroscopy - Limbal Redness Score	Limbal redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).	One week
Biomicroscopy - Corneal Staining Score	Corneal staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).	One week
Biomicroscopy - Conjunctival Staining Score	Conjunctival staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).	One week
Biomicroscopy - Papillary Conjunctivitis Score	Papillary conjunctivitis- slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).	One week
Horizontal Centration - Lens Fit	Horizontal centration graded by -2 to 2 (-2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal).	Baseline (after 5 minutes of lens dispense)
Horizontal Centration - Lens Fit	Horizontal centration graded by -2 to 2 (-2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal).	One Week
Vertical Centration Grade - Lens Fit	Vertical centration graded by -2 to 2 (-2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior).	Baseline (after 5 minutes of lens dispense)
Vertical Centration Grade - Lens Fit	Vertical centration graded by -2 to 2 (-2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior).	One week
Corneal Coverage Grade	Corneal coverage graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).	Baseline (after 5 minutes of lens dispense)
Corneal Coverage Grade	Corneal coverage graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).	One week
Post-Blink Movement Grade	Post-blink movement graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).	Baseline (after 5 minutes of lens dispense)
Post-Blink Movement Grade	Post-blink movement graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).	1 week
Ocular Redness Rating	Ocular redness rating rated on a scale 0-100 (0=extremely poor, intolerable levels of redness to 100 = excellent, no redness)	1 week

Collaborators and Investigators

• Sponsor: Coopervision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2019
• Primary Completion (Actual): November 5, 2019
• Study Completion (Actual): November 20, 2019

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: EX-MKTG-75

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes