Healthy VolunteersNCT01252147

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

An observational study of Healthy Volunteers, run by Allergan at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: No treatment
How many people: 68 participants
Where: 1 siteJapan
Study dates: Dec 2010to Dec 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Japanese adults

Who may be able to join

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

Who cannot join

Permanent eyelid makeup or eyelash implants of any kind
Eyelash tint or dye application within 2 months
Eyelash extensions within 3 months

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Ueno, Tokyo

Other trials in Japan

About this study

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

Conditions: Healthy Volunteers
Being tested: No treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No treatmentOther
No treatment (intervention) will be provided in this study

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Inter-Rater Reliability of Assessing Overall Eyelash Prominence Using the Japanese Global Eyelash Assessment Scale (GEA-J) at 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.
Measured: Day 1
Overall Intra-Rater Reliability of Assessing Overall Eyelash Prominence Using the Japanese Global Eyelash Assessment Scale (GEA-J) at 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.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Dec 2010

First posted2 Dec 2010 (estimated)
Study startDec 2010
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01252147
Sponsor's protocol ID: 192024-066
Status last verified: Aug 2012
First submitted: 1 Dec 2010
Last updated: 28 Sep 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Inter-rater and Intra-rater Reliability Study of the Global Eyelash Assessment Scale for Assessment of Overall Eyelash Prominence
ClinicalTrials.gov ID: NCT01252147
Acronym / sponsor ID: 192024-066
Conditions: Healthy Volunteers
Study type: Observational
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 2 Dec 2010 (estimated)
Results: Posted 28 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Japanese adults

Key inclusion criteria (1 listed)

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

Key exclusion criteria (3 listed)

Permanent eyelid makeup or eyelash implants of any kind
Eyelash tint or dye application within 2 months
Eyelash extensions within 3 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No treatmentNo treatment (intervention) will be provided in this study	Other	–

Primary outcome

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.
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.

Results and safety

Results posted to the registry on 28 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	68	68

Primary outcome: 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. Number (95% Confidence Interval). Unit: Kendall's W

Measure	All Participants n = 68
Value	0.891 (0.653 to 1.000)

Population analysed: Enrolled population, defined as all patients who were enrolled in (started) the study.

Primary outcome: 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. Number (95% Confidence Interval). Unit: Kappa statistics

Measure	All Participants n = 68
Value	0.818 (0.785 to 0.850)

Population analysed: Enrolled population, defined as all patients who were enrolled in (started) the study.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Volunteers, run by Allergan at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01252147.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2012.