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

Sponsor
CIBA VISION (Industry)
Overall Status
Completed
CT.gov ID
NCT01155726
Collaborator
(none)
134
1
4
9.1
14.8

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
  • 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
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
134 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Feb 1, 2011
Actual Study Completion Date :
Feb 1, 2011

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:
  • Focus DAILIES®
  • 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:
  • DAILIES® AquaComfort Plus®
  • 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:
  • DAILIES® AquaComfort Plus®
  • 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:
  • 1-DAY ACUVUE® MOIST®
  • 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:
  • 1-DAY ACUVUE® MOIST®
  • 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:
  • Focus DAILIES®
  • 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:
  • DAILIES® AquaComfort Plus®
  • 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:
  • DAILIES® AquaComfort Plus®
  • 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:
  • 1-DAY ACUVUE® MOIST®
  • 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:
  • 1-DAY ACUVUE® MOIST®
  • 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:
  • DAILIES® AquaComfort Plus®
  • 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:
  • DAILIES® AquaComfort Plus®
  • 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:
  • 1-DAY ACUVUE®
  • 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:
  • 1-DAY ACUVUE® MOIST®
  • 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:
  • 1-DAY ACUVUE® MOIST®
  • 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:
  • DAILIES® AquaComfort Plus®
  • 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:
  • DAILIES® AquaComfort Plus®
  • 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:
  • 1-DAY ACUVUE®
  • 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:
  • 1-DAY ACUVUE® MOIST®
  • 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:
  • 1-DAY ACUVUE® MOIST®
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    Ages Eligible for Study:
    17 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    Responsible Party:
    CIBA VISION
    ClinicalTrials.gov Identifier:
    NCT01155726
    Other Study ID Numbers:
    • P-371-C-101
    First Posted:
    Jul 2, 2010
    Last Update Posted:
    Jul 10, 2012
    Last Verified:
    Apr 1, 2012
    Additional relevant MeSH terms:

    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

    1. Primary Outcome
    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

    [Not Specified]

    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
    Email
    Responsible Party:
    CIBA VISION
    ClinicalTrials.gov Identifier:
    NCT01155726
    Other Study ID Numbers:
    • P-371-C-101
    First Posted:
    Jul 2, 2010
    Last Update Posted:
    Jul 10, 2012
    Last Verified:
    Apr 1, 2012