Bimatoprost in the Treatment of Eyelash Hypotrichosis

NCT01698554 | Completed Phase 3 Results

• 2 other identifiers: 192024-0462012-003007-35
• Study Type: interventional
• Target: 464
• Locations: 4 countries
• Sites: 4

Brief Summary

This study will evaluate the safety and efficacy of bimatoprost solution formulation A compared with bimatoprost solution 0.03% (LATISSE®) and vehicle in the treatment of eyelash hypotrichosis (inadequate eyelashes).

Conditions

Idiopathic Eyelash Hypotrichosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)

  The investigator evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.

  Baseline, Month 4

Secondary Outcomes (4)

• Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)

  Baseline, Month 4

• Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA

  Baseline Month 4

• Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA

  Baseline, Month 4

• Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)

  Month 4

Study Arms (4)

bimatoprost formulation A solution

EXPERIMENTAL

Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Drug: bimatoprost formulation A solution

bimatoprost solution 0.03 %

ACTIVE COMPARATOR

Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Drug: bimatoprost solution 0.03 %

vehicle of bimatoprost formulation A solution

PLACEBO COMPARATOR

Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Drug: vehicle of bimatoprost formulation A solution

vehicle of bimatoprost solution 0.03 %

PLACEBO COMPARATOR

Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Drug: vehicle of bimatoprost solution 0.03 %

Interventions

bimatoprost formulation A solution DRUG

Bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

bimatoprost formulation A solution

bimatoprost solution 0.03 % DRUG

Bimatoprost solution 0.03 % (LATISSE®) applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Also known as: LATISSE®

bimatoprost solution 0.03 %

vehicle of bimatoprost formulation A solution DRUG

Vehicle of bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

vehicle of bimatoprost formulation A solution

vehicle of bimatoprost solution 0.03 % DRUG

Vehicle of bimatoprost solution 0.03 % applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

vehicle of bimatoprost solution 0.03 %

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth).

You may not qualify if:

• Damage to eyelid area (scarring) that may prevent growth of eyelashes
• Active eye diseases (glaucoma, uveitis, eye infections, chronic blepharitis or severe dry eye)
• Eye or eyelid surgery (including laser, refractive, intraocular filtering surgery, blepharoplasty) during the 3 months prior to screening
• Current eyelash implants of any kind
• Eyelash tint or dye application within 2 months of baseline
• Eyelash extensions application within 3 months of baseline
• Use of eyelash growth products within 6 months of baseline
• Treatments that may affect hair growth (minoxidil, cancer chemotherapeutic agents, etc) within 6 months prior to baseline.

Sponsors & Collaborators

• Allergan: lead

Study Sites (4)

Unknown Facility

Newport Beach, California, United States

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Stockholm, Sweden

Location

Unknown Facility

Norfolk, England, United Kingdom

Location

MeSH Terms

Interventions

Bimatoprost

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2012
• First Posted: October 3, 2012
• Study Start: November 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: February 10, 2015
• Results First Posted: February 10, 2015

Record last verified: 2015-01

Locations

US (1); SE (1); RU (1); GB (1)