Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children

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Brief Title

Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children


Brief Summary

      This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily
      application to the upper eyelid margins compared with vehicle in treating eyelash loss or
      hypotrichosis (inadequate or not enough eyelashes) in children.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Percentage of Participants With Adverse Events

Secondary Outcome

 Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA)

Condition

Eyelash Hypotrichosis

Intervention

bimatoprost ophthalmic solution 0.03%

Study Arms / Comparison Groups

 bimatoprost ophthalmic solution 0.03%
Description:  One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

71

Start Date

June 1, 2010

Completion Date

November 30, 2012

Primary Completion Date

November 2, 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Children who have inadequate eyelashes or have lost their eyelashes as a result of
             chemotherapy treatment, who completed their chemotherapy (intensive treatment) at
             least 4 weeks before starting the study, are considered to be at low risk for relapse
             of their cancer, and are well enough to complete the study

          -  Children who have minimal to moderate inadequate eyelashes due to alopecia areata

          -  Adolescents between the ages of 15-17 years who have minimal to marked inadequate
             eyelashes

        Exclusion Criteria:

          -  Any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants.

          -  Semi-permanent eyelash tint, dye or eyelash extension application within 3 months

          -  Use of over the counter eyelash growth products within 6 months.

          -  Use of prescription eyelash growth products (eg, Latisse®)

          -  Any eye condition that would prevent required ophthalmology exams
      

Gender

All

Ages

5 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Medical Director, , 

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT01023841

Organization ID

192024-040


Responsible Party

Sponsor

Study Sponsor

Allergan


Study Sponsor

Medical Director, Study Director, Allergan


Verification Date

April 2019