Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence

NCT01064882 | Completed Phase 2 Results

• 1 other identifier: 192024-051
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and efficacy of bimatoprost ophthalmic solution 0.005% or 0.015% compared with bimatoprost ophthalmic solution 0.03% once-daily application to the upper eyelid margins in increasing eyelash prominence

Conditions

Eyelash Hypotrichosis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Eyelash Length at Month 3

  Change from Baseline at Month 3 in eyelash length, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length.

  Baseline, Month 3

Secondary Outcomes (6)

• Change From Baseline in Upper Eyelash Thickness at Month 3

  Baseline, Month 3

• Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3

  Baseline, Month 3

• Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3

  Month 3

• Change From Baseline in Overall Eyelash Satisfaction at Month 3

  Baseline, Month 3

• Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3

  Baseline, Month 3

Study Arms (3)

bimatoprost ophthalmic solution 0.005%

EXPERIMENTAL

bimatoprost ophthalmic sterile solution 0.005%

Drug: bimatoprost ophthalmic solution 0.005%

bimatoprost ophthalmic solution 0.015%

EXPERIMENTAL

bimatoprost ophthalmic sterile solution 0.015%

Drug: bimatoprost ophthalmic solution 0.015%

bimatoprost ophthalmic solution 0.03%

ACTIVE COMPARATOR

bimatoprost ophthalmic solution 0.03%

Drug: bimatoprost ophthalmic solution 0.03%

Interventions

bimatoprost ophthalmic solution 0.005% DRUG

One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)

bimatoprost ophthalmic solution 0.005%

bimatoprost ophthalmic solution 0.015% DRUG

One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)

bimatoprost ophthalmic solution 0.015%

bimatoprost ophthalmic solution 0.03% DRUG

One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)

Also known as: LATISSE®

bimatoprost ophthalmic solution 0.03%

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female Caucasians between 30 and 55 years of age, with hypotrichosis (inadequate or not enough) of the eyelashes
• Eyelash prominence assessment of minimal or moderate

You may not qualify if:

• Any eye disease or abnormality
• Any permanent eyeliner or eyelash implants of any kind
• Any ocular surgery, semi-permanent eyelash tint, or eyelash extension application during the 3 months prior to study entry
• Any use of prescription eyelash growth products
• Any use of over the counter eyelash growth products during the 6 months prior to baseline
• Any use of treatments that may affect hair growth during the 6 months prior to baseline

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

San Diego, California, United States

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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: February 9, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 9, 2011
• Results First Posted: December 9, 2011

Record last verified: 2011-11

Locations

US (1)