ARGON: The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies
Study Details
Study Description
Brief Summary
The purpose of this study is to explore the effect of masking on subjective ratings for two daily disposable contact lenses.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Nelfilcon A, Masked, Unmasked 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
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.
Other Names:
Device: Nelfilcon A contact lens with comfort additive (DACP), unmasked
Commercially marketed, soft, hydrogel contact lens with comfort additive for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses and removed inserted by participant.
Other Names:
Device: Nelfilcon A contact lens with comfort additive (DACP), masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.
Other Names:
Device: Etafilcon A contact lens with comfort additive (1DAVM), unmasked
Commercially marketed, soft, hydrogel contact lens with comfort additive for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.
Other Names:
Device: Etafilcon A contact lens with comfort additive (1DAVM), masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.
Other Names:
|
Active Comparator: Nelfilcon A, Masked, Partially Masked 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
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.
Other Names:
Device: Nelfilcon A contact lens with comfort additive (DACP), masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.
Other Names:
Device: Nelfilcon A contact lens with comfort additive (DACP), partially masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Lens name and manufacturer on blister pack label concealed from participant. Lenses inserted and removed by the participant.
Other Names:
Device: Etafilcon A contact lens with comfort additive (1DAVM), masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.
Other Names:
Device: Etafilcon A contact lens with comfort additive (1DAVM), partially masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Lens name and manufacturer on blister pack label concealed from participant. Lenses inserted and removed by the participant.
Other Names:
|
Active Comparator: Etafilcon A, Masked, Unmasked 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. |
Device: Nelfilcon A contact lens with comfort additive (DACP), unmasked
Commercially marketed, soft, hydrogel contact lens with comfort additive for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses and removed inserted by participant.
Other Names:
Device: Nelfilcon A contact lens with comfort additive (DACP), masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.
Other Names:
Device: Etafilcon A contact lens
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.
Other Names:
Device: Etafilcon A contact lens with comfort additive (1DAVM), unmasked
Commercially marketed, soft, hydrogel contact lens with comfort additive for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.
Other Names:
Device: Etafilcon A contact lens with comfort additive (1DAVM), masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.
Other Names:
|
Active Comparator: Etafilcon A, Masked, Partially Masked 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 (partially masked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode. |
Device: Nelfilcon A contact lens with comfort additive (DACP), masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.
Other Names:
Device: Nelfilcon A contact lens with comfort additive (DACP), partially masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Lens name and manufacturer on blister pack label concealed from participant. Lenses inserted and removed by the participant.
Other Names:
Device: Etafilcon A contact lens
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.
Other Names:
Device: Etafilcon A contact lens with comfort additive (1DAVM), masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.
Other Names:
Device: Etafilcon A contact lens with comfort additive (1DAVM), partially masked
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Lens name and manufacturer on blister pack label concealed from participant. Lenses inserted and removed by the participant.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Average Subjective Comfort [Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
17 years of age or older.
-
Ocular exam within 2 years.
-
Currently wearing soft contact lenses on a daily wear basis.
-
Contact lens prescription between +6.00D and -10.00D.
-
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
-
Any ocular disease.
-
Use of systemic or ocular medications that may affect ocular health.
-
Unable to achieve an acceptable fit with the study lenses.
-
Anisometropia >1.00D or astigmatism >0.75D.
-
Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Centre for Contact Lens Research: University of Waterloo | Waterloo | Ontario | Canada | N2L 3G1 |
Sponsors and Collaborators
- CIBA VISION
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P-371-C-101
Study Results
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 Detail | 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. 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 |
Period Title: Period 1, 3 Days (Masked) | ||||
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 enrolled and dispensed participants. |
Overall Participants | 116 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
25
(9)
|
Sex: Female, Male (Count of Participants) | |
Female |
79
68.1%
|
Male |
37
31.9%
|
Outcome Measures
Title | Average Subjective Comfort |
---|---|
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), 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. |
Measure Participants | 23 | 23 | 28 | 28 | 23 | 23 | 28 | 28 | 20 | 20 | 25 | 25 | 20 | 20 | 25 | 25 |
Mean (Standard Deviation) [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 | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -0.4 | |
Confidence Interval |
(2-Sided) 95% -2.2 to 1.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
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 | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 0.5 | |
Confidence Interval |
(2-Sided) 95% -1.5 to 2.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
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 | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 1.1 | |
Confidence Interval |
(2-Sided) 95% -0.1 to 2.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
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 | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 1.9 | |
Confidence Interval |
(2-Sided) 95% 0.2 to 3.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
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 | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -1.1 | |
Confidence Interval |
(2-Sided) 95% -3.3 to 1.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
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 | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -0.4 | |
Confidence Interval |
(2-Sided) 95% -1.9 to 1.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
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 | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -2.9 to 2.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
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 | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 0.4 | |
Confidence Interval |
(2-Sided) 95% -1.1 to 1.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
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 contact lenses | Nelfilcon A with comfort additive contact lenses | ||||
All Cause Mortality |
||||||||
Nelfilcon A | Etafilcon A | 1DAVM | DACP | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
Nelfilcon A | Etafilcon A | 1DAVM | DACP | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/127 (0%) | 0/125 (0%) | 0/100 (0%) | 0/100 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
Nelfilcon A | Etafilcon A | 1DAVM | DACP | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/127 (0%) | 0/125 (0%) | 0/100 (0%) | 0/100 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Name/Title | Director of Clinical Trials |
---|---|
Organization | Alcon Research |
Phone | 1-800-241-7629 |
- P-371-C-101