Glaucoma, Application Site Pigmentation Changes
Conditions
Keywords
periocular skin pigmentation, Lumigan, Travatan, Xalatan, latanoprost, bimatoprost, travoprost
Brief summary
The purpose of this study is to study changes in skin color that may be caused by using one of the three eye medicines: Xalatan, Travatan or Lumigan.
Detailed description
One uncommon side effect of prostaglandin eye drops is a change in color of the skin around the eyes, which is reversible. There are three different brands of the medicine which are equally effective in lowering eye pressure but their likelihood of changing skin color is unknown. Qualifying patients will be randomly assigned to use one of the three eye drops. We will take skin color measurements from several locations on the face over one year to measure pigmentation changes.
Interventions
DRUGlatanoprost
Xalatan/latanoprost 0.005% ophthalmic solution one drop qhs for one year
DRUGbimatoprost
Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year
DRUGtravoprost
Travatan/travoprost 0.004% ophthalmic solution one drop qhs for one year
Sponsors
Summa Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients recently diagnosed with primary open angle glaucoma or ocular hypertension * Caucasian and African American ethnicities * Male and Female * Age 30 and above
Exclusion criteria
* A history of ocular medication use within the last 12 months * Inflammatory/ allergic skin diseases or dermatitis * presence of periocular hyperpigmented skin lesions * Systemic pigmentation disorders * Use of systemic drugs that can affect skin pigmentation * Visitation of tanning salons, or use of self tanning products * Pregnancy or patients planning to become pregnant in the near future
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients. | one year | Periocular skin color was measured with the Minolta Chroma Meter CR-400 and the L\*a\*b\* system, also known as Commission Internationale de l'Eclairage. This is a well-accepted unit of measurement in which L\* corresponds to brightness and a\* and b\* correspond to chromaticity. Measurements were taken at baseline and 1 year. Data from each time point and each location (upper and lower eyelids or cheeks/face) were averaged, and subtracted from the baseline value for that location. Six predetermined areas on and around the upper and lower eyelid and 2 areas of the face/cheek were measured.Upper and lower eyelid values were averaged and reported as single value for each location ie;-upper eyelids, lower eyelid and cheek/face. A decrease in luminance indicates increased pigmentation at the site of measurement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lumigan Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s) | 19 |
| Xalatan Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s) | 21 |
| Travatan Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s) | 17 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 5 | 1 | 3 |
| Overall Study | Lost to Follow-up | 7 | 6 | 6 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | Lumigan | Xalatan | Travatan | Total |
|---|---|---|---|---|
| Age, Continuous | 61.5 years | 59.2 years | 60.5 years | 60.4 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 19 Participants | 13 Participants | 47 Participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 9 Participants | 27 Participants |
| Sex: Female, Male Male | 9 Participants | 13 Participants | 8 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 32 | 0 / 29 | 0 / 28 |
| serious Total, serious adverse events | 0 / 32 | 0 / 29 | 0 / 28 |
Outcome results
Primary
The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients.
Periocular skin color was measured with the Minolta Chroma Meter CR-400 and the L\*a\*b\* system, also known as Commission Internationale de l'Eclairage. This is a well-accepted unit of measurement in which L\* corresponds to brightness and a\* and b\* correspond to chromaticity. Measurements were taken at baseline and 1 year. Data from each time point and each location (upper and lower eyelids or cheeks/face) were averaged, and subtracted from the baseline value for that location. Six predetermined areas on and around the upper and lower eyelid and 2 areas of the face/cheek were measured.Upper and lower eyelid values were averaged and reported as single value for each location ie;-upper eyelids, lower eyelid and cheek/face. A decrease in luminance indicates increased pigmentation at the site of measurement.
Time frame: one year
Population: Newly diagnosed glaucoma and ocular hypertension, males and females, age 30 and up, Caucasians and African Americans.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lumigan | The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients. | Lower Lid | -0.37 L*a*b* | Standard Error 0.3 |
| Lumigan | The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients. | Upper Lid | -0.90 L*a*b* | Standard Error 0.67 |
| Lumigan | The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients. | Cheek/Face | 0.30 L*a*b* | Standard Error 0.29 |
| Xalatan | The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients. | Lower Lid | 0.48 L*a*b* | Standard Error 0.4 |
| Xalatan | The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients. | Upper Lid | -1.42 L*a*b* | Standard Error 0.57 |
| Xalatan | The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients. | Cheek/Face | 0.55 L*a*b* | Standard Error 0.33 |
| Travatan | The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients. | Upper Lid | -0.90 L*a*b* | Standard Error 0.53 |
| Travatan | The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients. | Cheek/Face | 0.51 L*a*b* | Standard Error 0.41 |
| Travatan | The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients. | Lower Lid | 0.17 L*a*b* | Standard Error 0.4 |
Comparison: One way ANOVA of Upper Lidp-value: 0.769ANOVA
Comparison: One way ANOVA of Lower Lidp-value: 0.23ANOVA
Comparison: One way ANOVA of cheek/facep-value: 0.851ANOVA