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Inter-rater and Intra-rater Reliability Study of the Global Eyelash Assessment Scale for Assessment of Overall Eyelash Prominence

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ClinicalTrials.gov Identifier: NCT01252147
Recruitment Status : Completed
First Posted : December 2, 2010
Results First Posted : September 28, 2012
Last Update Posted : September 28, 2012
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
This study will evaluate the inter-rater and intra-rater reliability of the Global Eyelash Assessment (GEA) scale with photonumeric guide in Japanese subjects.

Condition or disease Intervention/treatment
Healthy Volunteers Other: No treatment

Study Design
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Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : December 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010
Groups and Cohorts
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Intervention Details:
  • Other: No treatment
    No treatment (intervention) will be provided in this study

Outcome Measures
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Primary Outcome Measures :
  1. Overall Inter-Rater Reliability of Assessing Overall Eyelash Prominence Using the Japanese Global Eyelash Assessment Scale (GEA-J) at Day 1 [ Time Frame: Day 1 ]
    Inter-rater agreement (among raters) of the GEA-J scores (1=minimum,2=moderate, 3=marked, 4=very marked) to assess eyelash prominence was evaluated using Kendall's coefficient of concordance (Kendall's W). Each of 7 raters who scored 68 subjects' eyelashes using GEA-J Scale with photonumeric guide at 2 different time points at day 1. The overall inter-rater agreement for Kendall's W for all raters combined was estimated based on the average of the scores from those 2 different time points. The degree of agreement of the point estimates of Kendall's W was interpreted according to the reference range scale that was pre-defined as: <=0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial, 0.81-1:00: almost perfect. The 95% confidence interval for Kendall's W is provided.

  2. Overall Intra-Rater Reliability of Assessing Overall Eyelash Prominence Using the Japanese Global Eyelash Assessment Scale (GEA-J) at Day 1 [ Time Frame: Day 1 ]
    Intra-rater (within raters) agreement of the GEA-J scores (1=minimum, 2=moderate, 3=marked, 4=very marked) to assess eyelash prominence was evaluated by weighted Kappa statistics. Weighted Kappa statistics were calculated for each of 7 rater who evaluated 68 subjects using GEA-J scale with photonumeric guide, assessing agreement between 2 different time points at day 1. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: <=0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial, 0.81-1:00: almost perfect. The 95% confidence interval for Kappa statistics is provided.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Japanese adults
Criteria

Inclusion Criteria:

  • Able and willing to remove all eye makeup and facial jewelry during study

Exclusion Criteria:

  • Permanent eyelid makeup or eyelash implants of any kind
  • Eyelash tint or dye application within 2 months
  • Eyelash extensions within 3 months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252147


Locations
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Japan
Ueno, Tokyo, Japan
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01252147    
Other Study ID Numbers: 192024-066
First Posted: December 2, 2010    Key Record Dates
Results First Posted: September 28, 2012
Last Update Posted: September 28, 2012
Last Verified: August 2012