The Clinical Comparison of Narafilcon A and Stenfilcon A... | NCT02920970

NCT02920970

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
narafilcon A	Active Comparator	Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.	Device: narafilcon A
stenfilcon A	Active Comparator	Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.	Device: stenfilcon A

Name	Type	Description	Arm Group Labels	Other Names
narafilcon A	Device	contact lens	narafilcon A
stenfilcon A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ocular Physiology	Ocular physiology assessment of narafilcon A and stenfilcon A lenses by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).	1 week
Visual Acuity	Visual acuity for narafilcon A and stenfilcon A are assessed by LogMAR. High contrast is measured with black letters on a white background. Low contrast is measured with gray letters on a white background.	1 week
Comfort Level of Stenfilcon A and Narafilcon A Lenses	Subjective responses for overall comfort will be evaluated for each pair using questionnaire (Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).	1 week
Dryness of Stenfilcon A and Narafilcon A Lenses	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 of Stenfilcon A and Narafilcon A Lenses	Subjective responses for vision will be evaluated for each pair using questionnaire (Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent).	1 week
Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses	Lens surface for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)	1 week
Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects will only be eligible for the study if:
1. They are of legal age (18) and capacity to volunteer.
2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They agree not to participate in other clinical research for the duration of this study.
5. They have a contact lens spherical prescription between -1.00 to - 6.00D (Diopters) (inclusive)
6. They have a spectacle cylindrical correction of -0.75D or less in each eye.
7. They can be satisfactorily fitted with the study lens types.
8. 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.
9. They currently use soft contact lenses or have done so in the previous six months.
10. They are willing to comply with the wear schedule (at least six days per week and for at least eight hours per day).
11. They own a wearable pair of spectacles.

Exclusion Criteria:

Subjects will not be eligible to take part in the study if:
1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They have had cataract surgery.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. They are pregnant or breast-feeding.
8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
9. 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.
10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
11. They currently wear either the stenfilcon A lens or narafilcon A lens.

Name	Affiliation	Role
Philip Morgan, PhD, FAAO, FBCLA	Eurolens Research, University of Manchester	Study Director

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

ID	Title	Description
FG000	Stenfilcon A First Then Narafilcon A	Participants are randomized to wear stenfilcon A lens first for one week then narafilcon A.
FG001	Narafilcon A First Then Stenfilcon A	Participants are randomized to wear narafilcon A lens first for one week then stenfilcon A.

Baseline Characteristics Module

ID	Title	Description
BG000	Overall Number of Baseline Participants	Total number of participants enrolled in the study.

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 narafilcon A and stenfilcon A lenses by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

There were 2 participants excluded from the analysis for narafilcon A due to protocol deviations

Posted

Mean

Standard Deviation

units on a scale

1 week

ID	Title	Description
OG000	Stenfilcon A	Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.
OG001	Narafilcon A	Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.

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	Stenfilcon A	Participants are randomized to wear stenfilcon A as the first or second lens pair for one week during the cross over study.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Non-ocular Non-Significant	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	Common cold

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases