Evaluation of Vision Effects of a Cosmetic Tinted Hydroge... | NCT02886923

NCT02886923

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

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
Test/Control Sequence	Experimental	Subjects will wear the Hioxifilcon A Test contact lens and then the Hioxifilcon A with Cosmetic Ring Control contact lens for approximately three to four hours at each of the two measurement visits.	Device: Hioxifilcon A Test Device: Hioxifilcon A With Cosmetic Ring Control
Control/Test Sequence	Active Comparator	Subjects will wear the Hioxifilcon A with Cosmetic Ring Control contact lens and then the Hioxifilcon A Test contact lens for approximately three to four hours at each of the two measurement visits.	Device: Hioxifilcon A Test Device: Hioxifilcon A With Cosmetic Ring Control

Name	Type	Description	Arm Group Labels	Other Names
Hioxifilcon A Test	Device	contact lens made with hioxifilcon A material	Control/Test Sequence Test/Control Sequence

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Binocular Functional Visual Performance Under Distance Day Time Conditions (250 cd/m2) for Centrally Presented High Contrasts (HC) Time Controlled Visual Acuity (TCVA) Targets.	Time Controlled Visual Acuity (TCVA) was assessed at 4 m using 250 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets.	15 minutes post lens fit

Secondary Outcomes

Measure	Description	Time Frame
The Binocular Functional Visual Performance Under Distance Night Time Conditions (2.5 cd/m2) for Centrally Presented HC TCVA Targets.	Time Controlled Visual Acuity (TCVA) was assessed at 4 m using 2.5 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets.	15 Minutes post lens fitting

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be between 35 and 42 years of age (inclusive).
The subject's vertex corrected spherical equivalent distance refraction must be in the range of -6.00 Diopters (D) to +4.00 D in each eye.
The subject's refractive cylinder must be ≤ 0.75 D in each eye.
The subject must have best corrected visual acuity of 20/30 or better in each eye.
The subject must be an adapted soft contact lens wearer in both eyes (defined as a minimum of 6 hours of Daily Wear (DW) for a minimum of 1 month prior to the study).
The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria:

Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV) by self-report.
Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
Any ocular infection.
Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Habitual contact lens type is toric, bifocal, in monovision contact lens wear, or is worn as extended wear.
Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Facility	Status	City	State	ZIP	Country	Contacts
Optometry Technology Group, Ltd.		London		SW1E 6AU	United Kingdom

ID	Title	Description
FG000	Hioxilfilcon A (Test)/ Hioxifilcon A (Control)	Subjects that received the Test lens during the first study period and the Control lens during the second study period.
FG001	Hioxilfilcon A (Control)/ Hioxifilcon A (Test)	Subjects that were received the Control lens during the first study period and the Test lens during the second stud period.

Baseline Characteristics Module

ID	Title	Description
BG000	Dispensed Subjects	All subjects that were dispensed a study 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

The Binocular Functional Visual Performance Under Distance Day Time Conditions (250 cd/m2) for Centrally Presented High Contrasts (HC) Time Controlled Visual Acuity (TCVA) Targets.

Time Controlled Visual Acuity (TCVA) was assessed at 4 m using 250 cd/m2 luminance. The luminance requirements were same at the target and at the eye.

Binocular functional visual performance was measured for the centrally presented high contrasts targets.

All subjects who had successfully completed all required visits without any protocol deviations that the study responsible clinician documented as impacting the assessment of the hypotheses.

Posted

Mean

Standard Deviation

-10 x logMAR

15 minutes post lens fit

ID	Title	Description
OG000	Hioxifilcon A (Test)	Subjects that wore the Test lens in either the first or second period of the 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	Hioxifilcon A (Test)	Subjects that wore the Test lens in either the first or second period of the study.