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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01252147
First received: December 1, 2010
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

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 Intervention
Healthy Volunteers
Other: No treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 68
Study Start Date: December 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: No treatment
    No treatment (intervention) will be provided in this study
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252147

Locations
Japan
Ueno, Tokyo, Japan
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01252147     History of Changes
Other Study ID Numbers: 192024-066
Study First Received: December 1, 2010
Results First Received: November 30, 2011
Last Updated: August 24, 2012
Health Authority: Japan: Japanese Ministry of Health and Welfare

ClinicalTrials.gov processed this record on October 23, 2014