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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
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
Hide 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
Arm/Group Title Overall
Hide Arm/Group Description This reporting group includes all enrolled and dispensed participants.
Overall Number of Baseline Participants 116
Hide 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%
1.Primary Outcome
Title Average Subjective Comfort
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
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
Hide 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   --/--   --/--   --/--   --/-- 
Hide 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%) 
Hide 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%) 
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