The Clinical Comparison of Senofilcon A and Stenfilcon A... | NCT02643004

NCT02643004

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Senofilcon A	Active Comparator	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.	Device: Senofilcon A
Stenfilcon A	Active Comparator	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.	Device: Stenfilcon A

Name	Type	Description	Arm Group Labels	Other Names
Senofilcon A	Device	contact lens	Senofilcon A
Stenfilcon A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ocular Physiology	Ocular physiology assessment of senofilcon A and stenfilcon A lenses by biomicroscopy for the following: corneal staining, conjunctival hyperaemia, limbal hyperaemia, and conjunctival staining. Scale 0-4, 0.25 steps, 0=normal, 4=severe.	Baseline and 1 week
Overall Subjective Score of Lenses	Subjective responses will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, 100=excellent.	Baseline and 1 week
Comfort	Subjective responses for comfort will be evaluated for each pair using questionnaire. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.	Baseline and 1 week
Dryness	Subjective responses for dryness will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness.	1 week
Vision	Subjective responses for vision will be evaluated for each pair using questionnaire. Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent.	Baseline and 1 week

Secondary Outcomes

Measure	Description	Time Frame
Horizontal Centration	Lens fit, horizontal centration will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal	Baseline
Horizontal Centration

Eligibility Module

Eligibility Criteria

Inclusion criteria

Subjects will only be eligible for the study if:

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 spectacle cylindrical correction of -0.75D or less in each eye.
At dispensing, they can attain at least 0.10 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 six days per week and for at least eight hours per day).

Exclusion criteria

Subjects will not be eligible to take part in the study if:

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 lactating.
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 MyDay (daily) or the Acuvue Oasys (2 weekly) lens.

Name	Affiliation	Role
Carole Maldonado-Codinal, PhD	Eurolens Research, University of Manchester	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Eurolens Research - The University of Manchester		Manchester		M13 9PL	United Kingdom

Arm/Group Information

ID	Title	Description
FG000	Senofilcon A, Then Stenfilcon A	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens Stenfilcon A: contact lens
FG001	Stenfilcon A, Then Senofilcon A	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens Senofilcon A: contact lens

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Overall Baseline Characteristics	Participants were randomized to wear senofilcon A or stenfilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens Stenfilcon A: contact lens

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

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

Ocular Physiology

Ocular physiology assessment of senofilcon A and stenfilcon A lenses by biomicroscopy for the following: corneal staining, conjunctival hyperaemia, limbal hyperaemia, and conjunctival staining. Scale 0-4, 0.25 steps, 0=normal, 4=severe.

Protocol deviations occurred for 2 participants and therefore resulted in incomplete data sets.

Posted

Mean

Standard Deviation

units on a scale

Baseline and 1 week

ID	Title	Description
OG000	Senofilcon A	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens
OG001	Stenfilcon A	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon 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	Senofilcon A	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases