Trial Outcomes & Findings for Safety and Efficacy Study of Bimatoprost to Treat Hypotrichosis of the Eyelashes After Application to the Eyelid Margin (NCT NCT00907426)

Last Updated: 2012-09-19

Results Overview

Percentage of Treatment Responders at Month 4 defined by: a) at least a 1-grade improvement from baseline in the Global Eyelash Assessment (GEA) score, AND b) at least a 3-point improvement from baseline in the total score for Domain 2 of the Eyelash Symptom Questionnaire (ESQ). The GEA 4-point scale assessed eyelash prominence from 1 (minimal) to 4 (very marked). Domain 2 of the ESQ assessed subjective attributes of confidence, attractiveness, and professionalism rated on a 5-point scale from 1 (very much disagree) to 5 (very much agree) for a total score between 3 and 15.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

368 participants

Primary outcome timeframe

Month 4

Results posted on

2012-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Bimatoprost 0.03% Followed by Bimatoprost 0.03% Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.	Bimatoprost 0.03% Followed by Vehicle Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.	Vehicle Followed by Bimatoprost 0.03% Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
Treatment Period 1 (0 to 6 Months) STARTED	215	60	93
Treatment Period 1 (0 to 6 Months) COMPLETED	195	55	84
Treatment Period 1 (0 to 6 Months) NOT COMPLETED	20	5	9
Treatment Period 2 (6 to 12 Months) STARTED	195	55	84
Treatment Period 2 (6 to 12 Months) COMPLETED	184	52	77
Treatment Period 2 (6 to 12 Months) NOT COMPLETED	11	3	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Study of Bimatoprost to Treat Hypotrichosis of the Eyelashes After Application to the Eyelid Margin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bimatoprost 0.03% Followed by Bimatoprost 0.03% n=215 Participants Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.	Bimatoprost 0.03% Followed by Vehicle n=60 Participants Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.	Vehicle Followed by Bimatoprost 0.03% n=93 Participants Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.	Total n=368 Participants Total of all reporting groups
Age, Customized <45 Years	56 Participants n=5 Participants	18 Participants n=7 Participants	31 Participants n=5 Participants	105 Participants n=4 Participants
Age, Customized Between 45 and 65 years	151 Participants n=5 Participants	35 Participants n=7 Participants	53 Participants n=5 Participants	239 Participants n=4 Participants
Age, Customized >65 Years	8 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	24 Participants n=4 Participants
Sex: Female, Male Female	214 Participants n=5 Participants	58 Participants n=7 Participants	92 Participants n=5 Participants	364 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: Month 4

Population: Intent-to-Treat: All randomized subjects

Outcome measures

Outcome measures
Measure	Bimatoprost 0.03% n=275 Participants Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).	Vehicle n=93 Participants Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
Percentage of Treatment Responders at Month 4	39.3 Percentage of Subjects	10.9 Percentage of Subjects

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure

Change from Baseline to in upper eyelash length at Month 4, 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.

Outcome measures

Outcome measures
Measure	Bimatoprost 0.03% n=271 Participants Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).	Vehicle n=89 Participants Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
Change From Baseline in Upper Eyelash Length at Month 4 Baseline	5.40 Millimeters (mm) Standard Deviation 1.085	5.42 Millimeters (mm) Standard Deviation 1.138
Change From Baseline in Upper Eyelash Length at Month 4 Change from Baseline at Month 4	1.33 Millimeters (mm) Standard Deviation 1.110	0.07 Millimeters (mm) Standard Deviation 1.015

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure

Change from baseline in average progressive upper eyelash thickness at Month 4 was measured within 3 preset areas. Eyelash thickness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm\^2). Changes from baseline at Month 4 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness.

Outcome measures

Outcome measures
Measure	Bimatoprost 0.03% n=216 Participants Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).	Vehicle n=71 Participants Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4 Baseline	0.67 Millimeters squared (mm^2) Standard Deviation 0.376	0.82 Millimeters squared (mm^2) Standard Deviation 0.598
Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4 Change from Baseline at Month 4	0.59 Millimeters squared (mm^2) Standard Deviation 0.471	-0.07 Millimeters squared (mm^2) Standard Deviation 0.520

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure

Change from baseline in upper eyelash darkness at Month 4 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. A negative number value change from baseline indicated increased eyelash darkening.

Outcome measures

Outcome measures
Measure	Bimatoprost 0.03% n=215 Participants Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).	Vehicle n=70 Participants Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
Change From Baseline in Upper Eyelash Darkness at Month 4 Baseline	151.36 Eyelash Intensity Units Standard Deviation 24.670	148.82 Eyelash Intensity Units Standard Deviation 26.445
Change From Baseline in Upper Eyelash Darkness at Month 4 Change from Baseline at Month 4	-23.55 Eyelash Intensity Units Standard Deviation 20.787	-2.60 Eyelash Intensity Units Standard Deviation 18.592

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 4

Population: Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure

Percentage of subjects with at least a 1-grade improvement in GEA score at Month 4. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence.

Outcome measures

Outcome measures
Measure	Bimatoprost 0.03% n=275 Participants Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).	Vehicle n=92 Participants Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
Percentage of Subjects With at Least a 1-Grade Improvement in Global Eyelash Assessment (GEA) Score at Month 4	73.8 Percentage of Participants	28.3 Percentage of Participants

Adverse Events

Bimatoprost 0.03% Followed by Bimatoprost 0.03%

Serious events: 20 serious events

Other events: 75 other events

Deaths: 0 deaths

Bimatoprost 0.03% Followed by Vehicle

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

Vehicle Followed by Bimatoprost 0.03%

Serious events: 9 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Bimatoprost 0.03% Followed by Bimatoprost 0.03% n=214 participants at risk Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.	Bimatoprost 0.03% Followed by Vehicle n=60 participants at risk Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.	Vehicle Followed by Bimatoprost 0.03% n=92 participants at risk Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
Eye disorders Conjunctival Hyperaemia	12.1% 26/214 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.	6.7% 4/60 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.	6.5% 6/92 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.
Eye disorders Punctate Keratitis	5.6% 12/214 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.	5.0% 3/60 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.	5.4% 5/92 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.
Eye disorders Eyelids Pruritus	4.7% 10/214 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.	6.7% 4/60 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.	5.4% 5/92 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.
Eye disorders Erythema of Eyelid	4.2% 9/214 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.	10.0% 6/60 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.	5.4% 5/92 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.
Infections and infestations Upper Respiratory Tract Infection	4.2% 9/214 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.	0.00% 0/60 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.	5.4% 5/92 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.
Infections and infestations Nasopharyngitis	2.3% 5/214 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.	6.7% 4/60 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.	4.3% 4/92 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.
Nervous system disorders Headache	1.9% 4/214 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.	0.00% 0/60 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.	6.5% 6/92 The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Publication restrictions are in place

Restriction type: OTHER