Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Objective: To determine if Lumigan (bimatoprost) causes increased lash length when used in gel suspension applied to the base of the eyelashes. Methods: Subjects recruited from the Bascom Palmer Eye Institute were screened and those who met inclusion criteria were enrolled. Each participant received two vials of gel suspension, which contained bimatoprost and normal saline, respectively, each mixed 1:1 with GonakTM gel and labeled "right eye" and "left eye" according to randomization. The suspension was applied to the eyelashes every evening on the designated eye for 6 weeks. Lash length was measured with a caliper at enrollment, at weekly intervals during the study and at 1 and 3 months after study completion. Visual acuity, ocular symptoms, intraocular pressure and photographs were documented at these same intervals. Results: The average eyelash growth in the Lumigan group was 2.01mm (vs. control average of 1.13mm) which was a statistically significant difference (p=0.009). The average intraocular pressure decreased equally in both groups (2.14 mmHg). No change in visual acuity or iris discoloration was noted in any of the subjects. Discussion: Our data showed an increase in eyelash length with use of Lumigan in gel suspension, suggesting that it may have eyelash lengthening properties.
Study completed
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimatoprost Suspension | Active Comparator | Intervention to be administered: Each subject was given two suspensions, one mixed with Bimatoprost and one mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The intervention was the one eye with the Bimatoprost. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost Suspension | Drug | see prior |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Bimatoprost in Lengthening of Eyelashes | Eyelash growth after application of bimatoprost vs control (split face study). | 4.5 months (6 weeks of drug application and 3 months after discontinuing) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wendy W Lee, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami, Bascom Palmer Eye Institute | Miami | Florida | 33136 | United States |
Not provided
Through study advertisement with IRB approved flyers at the Bascom Palmer Eye Institute, 23 subjects were recruited for initial evaluation. Study recruitment and enrollment began in February 2008 and the study was completed in July of 2008, including 3 month post suspension use evaluations.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Bimatoprost Mixed With Gonak Into a Gel Suspension | Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bimatoprost Mixed With Gonak Into a Gel Suspension | Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy of Bimatoprost in Lengthening of Eyelashes | Eyelash growth after application of bimatoprost vs control (split face study). | Posted | Mean | Standard Deviation | mm | 4.5 months (6 weeks of drug application and 3 months after discontinuing) |
|
4.5 months
Serious adverse events = 0 Minor adverse events (irritation) = 2 subjects, discontinued from the study. It was not documented if the adverse events were only seen in the eye with the treatment arm and thus it was documented by subjects.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bimatoprost Mixed With Gonak Into a Gel Suspension | Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor Irritation | Eye disorders | Systematic Assessment | Minor irritation, conjunctival injection |
A larger and longer term study would help assess the incidence of ocular side effects related to the Bimatoprost. This randomized controlled study evaluated patients after only 6 weeks of application of the drug.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sara Wester | University of Miami | 305-326-6132 | swester2@med.miami.edu |
Not provided
| ID | Term |
|---|---|
| D006983 | Hypertrichosis |
| ID | Term |
|---|---|
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Patients were enrolled in the Bascom Palmer Eye Institute in Miami, FL. | Number | participants |
|
| Eyelash length | Lash length was measured using calipers and photos during the study, and the longest measured eyelashes were plucked from the upper eyelid of 13 of the 14 total enrolled patients at the end of the six weeks for comparison. Throughout the study, we used the same measuring technique, always measuring the length of the longest lash uncurled using a surgical caliper. Visual acuity, ocular symptoms, intraocular pressure and slit lamp exam were recorded at these same intervals. | Number | mm |
|
Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
|
|
| 0 |
| 21 |
| 2 |
| 21 |
|
Not provided
Not provided
Not provided
| D011465 |
| Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |