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

Ametropia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04067141
• Other study ID #: EX-MKTG-75
• Status: Completed
• Phase: N/A
• Start date: July 4, 2019
• Est. completion date: November 20, 2019

Study information

• Verified date: November 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 20, 2019
• Est. primary completion date: November 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ametropia
• Refractive Errors

Intervention

Device:
• somofilcon A
Contact Lens
• nelfilcon A
Contact Lens

Locations

Country	Name	City	State
United Kingdom	Eurolens Research	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	Overall Subjective Comfort	Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).	1 week
Primary	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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