The Clinical Comparison of Somofilcon A 1 Day and Nelfilc... | NCT04067141

NCT04067141

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
somofilcon A, then nelfilcon A	Experimental	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 Device: nelfilcon A
nelfilcon A, then somofilcon A	Experimental	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 Device: nelfilcon A

Name	Type	Description	Arm Group Labels	Other Names
somofilcon A	Device	Contact Lens	nelfilcon A, then somofilcon A somofilcon A, then nelfilcon A

Outcomes Module

Primary Outcomes

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.)

Secondary Outcomes

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

Eligibility Module

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.

Facility	Status	City	State	ZIP	Country	Contacts
Eurolens Research		Manchester		M13 9PL	United Kingdom

Arm/Group Information

ID	Title	Description
FG000	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. somofilcon A: Contact Lens nelfilcon A: Contact Lens
FG001	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. somofilcon A: Contact Lens nelfilcon A: Contact Lens

Periods

Title

Milestones

Reasons Not Completed

First Intervention

Type	Comment	Milestone Data
STARTED		FG00035 subjects FG00135 subjects
COMPLETED		FG00035 subjects FG00134 subjects
NOT COMPLETED		FG0000 subjects FG0011 subjects

Type	Comment	Reasons
Withdrawal by Subject		FG0000 subjects FG0011 subjects

Second Intervention

Type	Comment	Milestone Data
STARTED		FG00034 subjectsUnacceptable lens fit at dispense. One withdrawal by subject. FG00133 subjectsUnacceptable lens fit at dispense. One withdrawal by subject
COMPLETED		FG00034 subjects

Baseline Characteristics Module

ID	Title	Description
BG000	Overall Study	Subjects were randomized to wear somofilcon A 1 day and nelfilcon A for one week in this cross-over study.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.).

Posted

Mean

Standard Deviation

units on a scale

Baseline (after 5 minutes of lens dispense)

ID	Title	Description
OG000	Somofilcon A	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens
OG001	Nelfilcon A	Subjects will bilaterally wear the nelfilcon A lenses for 1 week. nelfilcon A: Contact Lens

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Somofilcon A	Subjects will bilaterally wear the somofilcon A lenses for 1 week. somofilcon A: Contact Lens