Clinical and Laboratory Evaluation of 3 Contact Lenses Wi... | NCT01791517

NCT01791517

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

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lens A (senofilcon A)	Other	Subjects randomized to Lens A will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).	Other: Solution 1 (Test) Other: Solution 2 (Test) Other: Solution 3 (Test) Other: Solution 4 (Control)
Lens B (galyfilcon A)	Other	Subjects randomized to Lens B will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).	Other: Solution 1 (Test) Other: Solution 2 (Test) Other: Solution 3 (Test) Other: Solution 4 (Control)
Lens C (etafilcon A)	Other	Subjects randomized to Lens C will be further randomized to 1 of 12 unique solution sequences; each subject will l receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).	Other: Solution 1 (Test) Other: Solution 2 (Test) Other: Solution 3 (Test) Other: Solution 4 (Control)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Solution 1 (Test)	Other	Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order	Lens A (senofilcon A)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Comfort Score (Senofilcon A Lens)	CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the senofilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).	2-Week Follow-up
Overall Comfort Score (Galyfilcon A Lens)	CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the galyfilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).	2-Week Follow-up
Overall Comfort Score (Etafilcon A Lens)	CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the etafilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).	2-Week Follow-up

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 instruction set forth in this clinical protocol.
The subject must be between 18 and 69 years of age.
The subject must be willing to participate in a 9-month study.
The subject must require a visual correction in both eyes.
Subjective refraction must result in a vertex-corrected spherical contact lens prescription of +2.00D to -8.00D in each eye.
The subject must have best-corrected visual acuity of 0.20 or better in each eye.
The subject must be a current wearer of spherical soft contact lenses (no bifocal contact lenses or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment.
The subject must require no more than -1.25D cylindrical correction in each eye after vertexing to the corneal plane.
The subject must have normal eye with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.

Exclusion Criteria:

Self-reported current pregnancy or lactation or plans to become pregnant during the study period (subjects who report becoming pregnant during the study will be discontinued).
Self-reported adverse reaction to a contact lens solution to be used in the study that in the opinion of the investigator would contraindicate use of that solution.
Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
Any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. equal to or greater than Grade 3 finding of edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland dysfunction) on the study specific classification scale or any other ocular abnormality that in the opinion of the investigator would contraindicate contact lens wear.
Any active ocular infection.
Current use of topical ophthalmic medications.
History of binocular vision abnormality or strabismus.
More than occasional use of dry eye/rewetting drops (more than 2 times per day on average).
Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.
History of severe allergic reaction or anaphylaxis.
Other active ocular disease that in the opinion of the investigator would contraindicate contact lens wear.
Employee of the investigational clinic (e.g. investigator, coordinator, technician)
They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Facility	Status	City	State	ZIP	Country	Contacts
University of Houston College of Optometry		Houston	Texas	77204	United States
University of Waterloo Centre for Contact Lens Research School of Optometry

PubMed Identifier	Type	Citation	Retractions
27391533	Derived	Schulze MM, Srinivasan S, Hickson-Curran SB, Berntsen DA, Howarth GF, Toubouti Y, Morgan P, Nichols JJ, Jones LW; Performance of Contact Lens Solutions Study Group. Lid Wiper Epitheliopathy in Soft Contact Lens Wearers. Optom Vis Sci. 2016 Aug;93(8):943-54. doi: 10.1097/OPX.0000000000000919.
27309523	Derived

Arm/Group Information

ID	Title	Description
FG000	Biotrue/PureMoist/Revitalens/Clear Care	Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
FG001	Biotrue/RevitaLens/Clear Care/PureMoist	Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
FG002	Biotrue/Clear Care/PureMoist/RevitaLens	Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
FG003	PureMoist/Biotrue/Clear Care/RevitaLens	Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
FG004	PureMoist/RevitaLens/Biotrue/Clear Care	Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
FG005	PureMoist/Clear Care/RevitaLens/Biotrue	Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
FG006	RevitaLens/Biotrue/PureMoist/Clear Care	Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
FG007	RevitaLens/PureMoist/Clear Care/Biotrue	Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
FG008	RevitaLens/Clear Care/Biotrue/PureMoist	Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
FG009	Clear Care/Biotrue/RevitaLens/PureMoist	Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
FG010	Clear Care/PureMoist/Biotrue/RevitaLens	Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
FG011	Clear Care/RevitaLens/PureMoist/Biotrue	Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.

Periods

Title

Milestones

Reasons Not Completed

Phase I: Period 1

Type	Comment	Milestone Data
STARTED		FG00019 subjects FG00120 subjects FG00220 subjects FG00319 subjects FG00420 subjects FG00520 subjects FG00620 subjects FG00720 subjects FG00820 subjects FG00920 subjects FG01018 subjects FG01120 subjects
COMPLETED		FG00018 subjects FG00118 subjects FG00218 subjects FG00317 subjects FG004
NOT COMPLETED		FG0001 subjects FG0012 subjects FG0022 subjects FG0032 subjects FG004

Type	Comment	Reasons
Withdrawal by Subject		FG0000 subjects FG0011 subjects FG0021 subjects FG003

Phase I: Period 2

Type	Comment	Milestone Data
STARTED		FG00018 subjects FG00118 subjects FG00218 subjects FG003

Phase I: Period 3

Type	Comment	Milestone Data
STARTED		FG00017 subjects FG00115 subjects FG00216 subjects FG003

Phase I: Period 4

Type	Comment	Milestone Data
STARTED		FG00017 subjects FG00114 subjects FG00216 subjects FG003

Phase II

Type	Comment	Milestone Data
STARTED		FG00017 subjects FG00114 subjects FG00216 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Etafilcon A	All subjects that were randomized to the study lens etafilcon A and 1 of 12 possible solution sequences.
BG001	Galyfilcon A	All subjects that were randomized to the study lens galyfilcon A and 1 of 12 possible solution sequences.

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

Overall Comfort Score (Senofilcon A Lens)

CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the senofilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).

The analysis population consists of all subjects that have completed all study visits without a major protocol deviation. The number of subjects reported above is the maximum number of subjects for that solution. The number of subjects may vary per solution/lens combination, since this study was stratified by contact lens.

Posted

Mean

Standard Deviation

units on a scale

2-Week Follow-up

ID	Title	Description
OG000

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	Solution 1(RevitaLens): Senofilcon A	Subjects that were randomized to the senofilcon A lens and received solution 1 during any of the 4 study periods.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Retro-peritoneal abscess in the kidney area.	Infections and infestations			According to the participant, his doctors hypothesized that the development of the abscess may be related to a perforated appendix he had in November 2011. This adverse event was deemed unrelated to the study by the investigator.