The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies (ARGON)

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ClinicalTrials.gov Identifier: NCT01155726

Recruitment Status : Completed

First Posted : July 2, 2010

Results First Posted : May 15, 2012

Last Update Posted : July 10, 2012

Sponsor:

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Conditions	Myopia Hyperopia
Interventions	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: Nelfilcon A contact lens with comfort additive (DACP), partially masked Device: Etafilcon A contact lens Device: Etafilcon A contact lens with comfort additive (1DAVM), unmasked Device: Etafilcon A contact lens with comfort additive (1DAVM), masked Device: Etafilcon A contact lens with comfort additive (1DAVM), partially masked
Enrollment	134

Participant Flow

Recruitment Details	134 participants were recruited and enrolled at 1 study center located in Canada. A 24-hour washout period of no lens wear preceded the 30-day adaptation phase.
Pre-assignment Details	18 participants were enrolled but not dispensed--i.e., discontinued prior to the 30-day adaptation phase. 116 participants started the adaptation phase, and baseline characteristics are presented for this group. 2 discontinued during the adaptation phase and 15 discontinued between adaptation and Period 1 dispense. 99 were dispensed into Period 1.


Arm/Group Title	Nelfilcon A, Masked, Unmasked	Nelfilcon A, Masked, Partially Masked	Etafilcon A, Masked, Unmasked	Etafilcon A, Masked, Partially Masked
Arm/Group Description	Nelfilcon A in adaptation phase. 1D...	Nelfilcon A in adaptation phase. 1D...	Etafilcon A in adaptation phase. 1D...	Etafilcon A in adaptation phase. 1D...
Arm/Group Description	Nelfilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, unmasked) in Period 2.	Nelfilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, partially masked) in Period 2.	Etafilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, unmasked) in Period 2.	Etafilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, partially masked) in Period 2.
Period Title: Period 1, 3 Days (Masked)
Started	24	20	30	25
Completed	23	20	28	25
Not Completed	1	0	2	0
Reason Not Completed
Inconvenience	1	0	2	0
Period Title: Period 2, 3 Days (Unmask) or (Partial)
Started	23	20	28	25
Completed	23	20	28	25
Not Completed	0	0	0	0

Baseline Characteristics

Arm/Group Title		Overall
Arm/Group Description		This reporting group includes all e...
Arm/Group Description		This reporting group includes all enrolled and dispensed participants.
Overall Number of Baseline Participants		116
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	116 participants
		25 (9)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	116 participants
	Female	79 68.1%
	Male	37 31.9%

Outcome Measures

1.Primary Outcome


Title	Average Subjective Comfort
Description	Participants were asked, "How would you rate your comfort with yo...
Description	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.
Time Frame	Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3

Outcome Measure Data

Analysis Population Description

Per protocol


Arm/Group Title	Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked	Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked	Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked	Etafilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked	Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM)	Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP)	Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM)	Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP)	Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial	Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Partial	Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial	Etafilcon A, Pd 1 Masked (DACP), Pd 2 Partial	Nelfilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM)	Nelfilcon A, Pd 1 Masked, Pd 2 Partial (DACP)	Etafilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM)	Etafilcon A, Pd 1 Masked, Pd 2 Partial (DACP)
Arm/Group Description:	Nelfilcon A (adaptation phase), fol...	Nelfilcon A (adaptation phase), fol...	Etafilcon A (adaptation phase), fol...	Etafilcon A (adaptation phase), fol...	Nelfilcon A (adaptation phase), fol...	Nelfilcon A (adaptation phase), fol...	Etafilcon A (adaptation phase), fol...	Etafilcon A (adaptation phase), fol...	Nelfilcon A (adaptation phase), fol...	Nelfilcon A (adaptation phase), fol...	Etafilcon A (adaptation phase), fol...	Etafilcon A (adaptation phase), fol...	Nelfilcon A (adaptation phase), fol...	Nelfilcon A (adaptation phase), fol...	Etafilcon A (adaptation phase), fol...	Etafilcon A (adaptation phase), fol...
Arm/Group Description:	Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.	Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.	Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.	Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.	Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.	Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.	Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.	Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.	Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.	Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.	Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.	Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.	Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.	Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.	Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.	Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
Overall Number of Participants Analyzed	23	23	28	28	23	23	28	28	20	20	25	25	20	20	25	25
Mean (Standard Deviation) Unit of Measure: Units on a scale
	94.1 (5.9)	92.8 (6.5)	94.1 (5.6)	91.8 (6.4)	93.7 (6.0)	93.3 (5.7)	95.2 (5.8)	93.7 (6.6)	93.4 (6.9)	93.4 (7.1)	93.6 (5.1)	92.2 (5.6)	92.3 (7.0)	93.1 (7.0)	93.5 (6.7)	92.6 (5.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked, Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM)
	Comments	Unmasked minus masked
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95% -2.2 to 1.4
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked, Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP)
	Comments	Unmasked minus masked
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95% -1.5 to 2.5
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked, Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM)
	Comments	Unmasked minus masked
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95% -0.1 to 2.2
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etafilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked, Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP)
	Comments	Unmasked minus masked
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95% 0.2 to 3.5
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial, Nelfilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM)
	Comments	Partial masked minus masked
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.1
	Confidence Interval	(2-Sided) 95% -3.3 to 1.2
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Partial, Nelfilcon A, Pd 1 Masked, Pd 2 Partial (DACP)
	Comments	Partial masked minus masked
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95% -1.9 to 1.1
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial, Etafilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM)
	Comments	Partial masked minus masked
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95% -2.9 to 2.7
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Etafilcon A, Pd 1 Masked (DACP), Pd 2 Partial, Etafilcon A, Pd 1 Masked, Pd 2 Partial (DACP)
	Comments	Partial masked minus masked
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95% -1.1 to 1.9
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Adverse events were collected for the duration of the study: 03 May 2010 through 01 February 2011.
Adverse Event Reporting Description	This reporting group includes all enrolled and exposed participants.

Arm/Group Title	Nelfilcon A	Etafilcon A	1DAVM	DACP
Arm/Group Description	Nelfilcon A contact lenses	Etafilcon A contact lenses	Etafilcon A with comfort additive c...	Nelfilcon A with comfort additive c...
Arm/Group Description	Nelfilcon A contact lenses	Etafilcon A contact lenses	Etafilcon A with comfort additive contact lenses	Nelfilcon A with comfort additive contact lenses
All-Cause Mortality
	Nelfilcon A	Etafilcon A	1DAVM	DACP
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Nelfilcon A	Etafilcon A	1DAVM	DACP
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/127 (0.00%)	0/125 (0.00%)	0/100 (0.00%)	0/100 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Nelfilcon A	Etafilcon A	1DAVM	DACP
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/127 (0.00%)	0/125 (0.00%)	0/100 (0.00%)	0/100 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Director of Clinical Trials
Organization:	Alcon Research
Phone:	1-800-241-7629

Layout table for additonal information

Responsible Party:	Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:	NCT01155726
Other Study ID Numbers:	P-371-C-101
First Submitted:	June 30, 2010
First Posted:	July 2, 2010
Results First Submitted:	February 15, 2012
Results First Posted:	May 15, 2012
Last Update Posted:	July 10, 2012

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