The Effect of Masking on Subjective Results During Daily... | NCT01155726

NCT01155726

Status Module

Oversight 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
Nelfilcon A, Masked, Unmasked	Active Comparator	Nelfilcon A worn in adaptation phase (bilaterally, 30 days). Period 1: 1DAVM and DACP (masked) worn contralaterally in random assignment for 3 days. Period 2: 1DAVM and DACP (unmasked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode.	Device: Nelfilcon A contact lens Device: Nelfilcon A contact lens with comfort additive (DACP), unmasked Device: Nelfilcon A contact lens with comfort additive (DACP), masked Device: Etafilcon A contact lens with comfort additive (1DAVM), unmasked Device: Etafilcon A contact lens with comfort additive (1DAVM), masked
Nelfilcon A, Masked, Partially Masked	Active Comparator	Nelfilcon A worn in adaptation phase (bilaterally, 30 days). Period 1: 1DAVM and DACP (masked) worn contralaterally in random assignment for 3 days. Period 2: 1DAVM and DACP (partially masked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode.	Device: Nelfilcon A contact lens Device: Nelfilcon A contact lens with comfort additive (DACP), masked Device: Nelfilcon A contact lens with comfort additive (DACP), partially masked Device: Etafilcon A contact lens with comfort additive (1DAVM), masked Device: Etafilcon A contact lens with comfort additive (1DAVM), partially masked
Etafilcon A, Masked, Unmasked	Active Comparator	Etafilcon A worn in adaptation phase (bilaterally, 30 days). Period 1: 1DAVM and DACP (masked) worn contralaterally in random assignment for 3 days. Period 2: 1DAVM and DACP (unmasked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nelfilcon A contact lens	Device	Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average Subjective Comfort	Participants were asked, "How would you rate your comfort with your study lenses?" and indicated their response by marking a continuum line ranging from 0=very poor comfort to 100=excellent comfort. Subjective comfort was collected at three time points (insertion, 4 hours, 8 hours) for 3 days, and the comfort ratings were averaged together.	Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Contact Lens Research: University of Waterloo		Waterloo	Ontario	N2L 3G1	Canada

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nelfilcon A, Masked, Unmasked	Nelfilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, unmasked) in Period 2.
FG001	Nelfilcon A, Masked, Partially Masked

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	Overall	This reporting group includes all enrolled and dispensed participants.

Units	Counts
Participants	BG000116

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

Average Subjective Comfort

Participants were asked, "How would you rate your comfort with your study lenses?" and indicated their response by marking a continuum line ranging from 0=very poor comfort to 100=excellent comfort. Subjective comfort was collected at three time points (insertion, 4 hours, 8 hours) for 3 days, and the comfort ratings were averaged together.

Per protocol

Posted

Mean

Standard Deviation

Units on a scale

Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3

ID	Title	Description
OG000	Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked	Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
OG001	Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked	Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
OG002	Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked	Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
OG003	Etafilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked	Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
OG004	Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM)	Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
OG005	Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP)	Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
OG006	Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM)	Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
OG007	Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP)	Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
OG008	Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial	Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
OG009	Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Partial	Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
OG010	Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial	Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
OG011	Etafilcon A, Pd 1 Masked (DACP), Pd 2 Partial	Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
OG012	Nelfilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM)	Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
OG013	Nelfilcon A, Pd 1 Masked, Pd 2 Partial (DACP)	Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
OG014	Etafilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM)	Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
OG015	Etafilcon A, Pd 1 Masked, Pd 2 Partial (DACP)	Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.

Units	Counts
Participants	OG00023 OG00123 OG00228 OG003

Title

Denominators

ID	Title	Description	Serious Events (At Risk)	Other Events (At Risk)
EG000	Nelfilcon A	Nelfilcon A contact lenses	127	127
EG001	Etafilcon A	Etafilcon A contact lenses	125	125
EG002	1DAVM	Etafilcon A with comfort additive contact lenses	100	100
EG003	DACP	Nelfilcon A with comfort additive contact lenses	100	100

ID	Term
D009216	Myopia
D006956	Hyperopia

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

ID	Term
D058257	Surgical Attire
D004865	Equipment and Supplies, Hospital
D004864	Equipment and Supplies
D011482	Protective Devices
D000067393	Personal Protective Equipment
D013523	Surgical Equipment
D008420	Manufactured Materials
D013676	Technology, Industry, and Agriculture