Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00693420

Enrollment

278

Registered

2008-06-09

Start date

2007-04-30

Completion date

2007-12-31

Last updated

2013-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eyelashes

Brief summary

This study evaluates the safety and effectiveness of topical bimatoprost solution for enhancing eyelash prominence.

Interventions

DRUGBimatoprost 0.03% sterile solution

Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily.

DRUGvehicle sterile solution

Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Dissatisfaction with eyelash prominence, * Eyelash prominence assessment of minimal or moderate, * Ability to provide written informed consent

Exclusion criteria

* Subjects without visible lashes, * Asymmetrical (uneven lashes or longer on one side than the other) eyelashes, * Any eye disease or abnormality, * Eye surgery, * Permanent eyeliner, * Eyelash implants, * Eyelash extension application, * Any use of eyelash growth products within 6 months of study entry, * Treatments that may effect hair growth, * Subjects requiring eye drop medications for glaucoma, * Subjects having a situation or condition, which the study doctor feels might put you at risk, may make the study results confusing, or may interfere with the study.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment)	Baseline to Week 20	The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 \[minimal\], 2 \[moderate\], 3 \[marked\], 4 \[very marked\])
Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16	Baseline to Week 16	The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 \[minimal\], 2 \[moderate\], 3 \[marked\], 4 \[very marked\])

Secondary

Measure	Time frame	Description
Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)	Baseline to Week 20	Upper eyelash length technologically measured in millimeters
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16	Baseline to Week 16	Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.
Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16	Baseline to Week 16	Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)
Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)	Baseline to Week 20	Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)	Baseline to Week 20	Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.
Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16	Baseline to Week 16	Upper eyelash length technologically measured in millimeters

Other

Measure	Time frame	Description
Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16	Baseline to Week 16	Overall, how satisfied are you with your eyelashes? Possible Answers on a 5 point scale as follows: 1. \- Very Satisfied 2. \- Satisfied 3. \- Neutral 4. \- Unsatisfied 5. \- Very Unsatisfied
Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment)	Baseline to Week 20	Overall, how satisfied are you with your eyelashes? Possible Answers on a 5 point scale as follows: (1 - Very Satisfied; 2 - Satisfied; 3 - Neutral; 4 - Unsatisfied; 5 - Very Unsatisfied)

Countries

Canada, United States

Participant flow

Participants by arm

Arm	Count
Bimatoprost 0.03% Solution	137
Vehicle Solution	141
Total	278

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	4	4
Overall Study	Lost to Follow-up	0	3
Overall Study	Personal Reasons	1	4
Overall Study	Protocol Violation	0	2
Overall Study	Sponsor Request - Conflict of Interest	0	2
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Bimatoprost 0.03% Solution	Vehicle Solution	Total
Age, Customized <45 years	44 participants	43 participants	87 participants
Age, Customized >65 years	11 participants	10 participants	21 participants
Age, Customized Between 45 and 65 years	82 participants	88 participants	170 participants
Sex: Female, Male Female	134 Participants	136 Participants	270 Participants
Sex: Female, Male Male	3 Participants	5 Participants	8 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	40 / —	22 / —
serious Total, serious adverse events	1 / —	2 / —

Outcome results

Primary

Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16

The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 \[minimal\], 2 \[moderate\], 3 \[marked\], 4 \[very marked\])

Time frame: Baseline to Week 16