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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumigan | Active Comparator | Patients assigned to Lumigan/bimatoprost one drop before bedtime (qhs) to affected eye(s) |
|
| Xalatan | Active Comparator | Patients assigned to Xalatan/latanoprost one drop before bedtime (qhs) to affected eye(s) |
|
| Travatan | Active Comparator | Patients assigned to Travatan/travoprost one drop before bedtime (qhs) to affected eye(s) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| latanoprost | Drug | Xalatan/latanoprost 0.005% ophthalmic solution one drop qhs for one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepak P Edward, MD | Summa Health System | Principal Investigator |
| Smajo Osmanovic, MD | Arlington eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arlington Eye Physicians | Arlington Heights | Illinois | 60005 | United States | ||
| Summa Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15534130 | Background | Albert DM, Gangnon RE, Zimbric ML, Damico CM, Fisher MR, Gleiser J, Grossniklaus HE, Green WR. A study of iridectomy histopathologic features of latanoprost- and non-latanoprost-treated patients. Arch Ophthalmol. 2004 Nov;122(11):1680-5. doi: 10.1001/archopht.122.11.1680. | |
| 12719085 | Background | Herndon LW, Robert D Williams, Wand M, Asrani S. Increased periocular pigmentation with ocular hypotensive lipid use in African Americans. Am J Ophthalmol. 2003 May;135(5):713-5. doi: 10.1016/s0002-9394(02)02146-3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lumigan | Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s) |
| FG001 | Xalatan | Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s) |
| FG002 | Travatan | Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lumigan | Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s) |
| BG001 | Xalatan | Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s) |
| 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 | 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. | Newly diagnosed glaucoma and ocular hypertension, males and females, age 30 and up, Caucasians and African Americans. | Posted | Mean | Standard Error | L*a*b* | one year |
Data was collected for one year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lumigan | Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recurrence of iritis at 6 week visit | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deepak P. Edward, MD | Summa Health System ( at the time of the trial) | 330-780-0399 | deepak.edward@gmail.com |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| D000069580 | Bimatoprost |
| D000069557 | Travoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| bimatoprost | Drug | Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year |
|
|
| travoprost | Drug | Travatan/travoprost 0.004% ophthalmic solution one drop qhs for one year |
|
|
| Akron |
| Ohio |
| 44304 |
| United States |
| 10926995 | Background | Kook MS, Lee K. Increased eyelid pigmentation associated with use of latanoprost. Am J Ophthalmol. 2000 Jun;129(6):804-6. doi: 10.1016/s0002-9394(00)00402-5. |
| 11296032 | Background | Wand M, Ritch R, Isbey EK Jr, Zimmerman TJ. Latanoprost and periocular skin color changes. Arch Ophthalmol. 2001 Apr;119(4):614-5. No abstract available. |
| 16286616 | Background | Kapur R, Osmanovic S, Toyran S, Edward DP. Bimatoprost-induced periocular skin hyperpigmentation: histopathological study. Arch Ophthalmol. 2005 Nov;123(11):1541-6. doi: 10.1001/archopht.123.11.1541. |
| 16935336 | Background | Doshi M, Edward DP, Osmanovic S. Clinical course of bimatoprost-induced periocular skin changes in Caucasians. Ophthalmology. 2006 Nov;113(11):1961-7. doi: 10.1016/j.ophtha.2006.05.041. Epub 2006 Aug 28. |
| 9154289 | Background | Wistrand PJ, Stjernschantz J, Olsson K. The incidence and time-course of latanoprost-induced iridial pigmentation as a function of eye color. Surv Ophthalmol. 1997 Feb;41 Suppl 2:S129-38. doi: 10.1016/s0039-6257(97)80020-3. |
| 10726794 | Background | Alm A, Widengard I. Latanoprost: experience of 2-year treatment in Scandinavia. Acta Ophthalmol Scand. 2000 Feb;78(1):71-6. doi: 10.1034/j.1600-0420.2000.078001071.x. |
| 15288975 | Background | McCarey BE, Kapik BM, Kane FE; Unoprostone Monotherapy Study Group. Low incidence of iris pigmentation and eyelash changes in 2 randomized clinical trials with unoprostone isopropyl 0.15%. Ophthalmology. 2004 Aug;111(8):1480-8. doi: 10.1016/j.ophtha.2003.11.013. |
| 15249358 | Background | Alm A, Schoenfelder J, McDermott J. A 5-year, multicenter, open-label, safety study of adjunctive latanoprost therapy for glaucoma. Arch Ophthalmol. 2004 Jul;122(7):957-65. doi: 10.1001/archopht.122.7.957. |
| 9692029 | Background | German EJ, Hurst MA, Wood D, Gilchrist J. A novel system for the objective classification of iris colour and its correlation with response to 1% tropicamide. Ophthalmic Physiol Opt. 1998 Mar;18(2):103-10. |
| 11584340 | Background | Takamoto T, Schwartz B, Cantor LB, Hoop JS, Steffens T. Measurement of iris color using computerized image analysis. Curr Eye Res. 2001 Jun;22(6):412-9. doi: 10.1076/ceyr.22.6.412.5490. |
| 10897347 | Background | Melgosa M, Rivas MJ, Gomez L, Hita E. Towards a colorimetric characterization of the human iris. Ophthalmic Physiol Opt. 2000 May;20(3):252-60. |
| 11174377 | Background | Elbaum M, Kopf AW, Rabinovitz HS, Langley RG, Kamino H, Mihm MC Jr, Sober AJ, Peck GL, Bogdan A, Gutkowicz-Krusin D, Greenebaum M, Keem S, Oliviero M, Wang S. Automatic differentiation of melanoma from melanocytic nevi with multispectral digital dermoscopy: a feasibility study. J Am Acad Dermatol. 2001 Feb;44(2):207-18. doi: 10.1067/mjd.2001.110395. |
| 8896947 | Background | Fullerton A, Fischer T, Lahti A, Wilhelm KP, Takiwaki H, Serup J. Guidelines for measurement of skin colour and erythema. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis. 1996 Jul;35(1):1-10. doi: 10.1111/j.1600-0536.1996.tb02258.x. |
| 8665445 | Background | Andreassi L, Flori L. Practical applications of cutaneous colorimetry. Clin Dermatol. 1995 Jul-Aug;13(4):369-73. doi: 10.1016/0738-081x(95)00069-r. |
| 15291306 | Background | Dornelles S, Goldim J, Cestari T. Determination of the minimal erythema dose and colorimetric measurements as indicators of skin sensitivity to UV-B radiation. Photochem Photobiol. 2004 Jun;79(6):540-4. doi: 10.1562/yg-03-08.1. |
| 15019115 | Background | Draaijers LJ, Tempelman FR, Botman YA, Kreis RW, Middelkoop E, van Zuijlen PP. Colour evaluation in scars: tristimulus colorimeter, narrow-band simple reflectance meter or subjective evaluation? Burns. 2004 Mar;30(2):103-7. doi: 10.1016/j.burns.2003.09.029. |
| 14535897 | Background | Youn JI, Park JY, Jo SJ, Rim JH, Choe YB. Assessment of the usefulness of skin phototype and skin color as the parameter of cutaneous narrow band UVB sensitivity in psoriasis patients. Photodermatol Photoimmunol Photomed. 2003 Oct;19(5):261-4. doi: 10.1034/j.1600-0781.2003.00047.x. |
| 11756647 | Background | De Felice C, Flori ML, Pellegrino M, Toti P, Stanghellini E, Molinu A, Tosi P, Bagnoli F. Predictive value of skin color for illness severity in the high-risk newborn. Pediatr Res. 2002 Jan;51(1):100-5. doi: 10.1203/00006450-200201000-00018. |
| 10906645 | Background | Tsai TF, Bowman PH, Jee SH, Maibach HI. Effects of glycolic acid on light-induced skin pigmentation in Asian and caucasian subjects. J Am Acad Dermatol. 2000 Aug;43(2 Pt 1):238-43. doi: 10.1067/mjd.2000.104894. |
| 10483358 | Background | Rubegni P, Cevenini G, Barbini P, Flori ML, Fimiani M, Andreassi L. Quantitative characterization and study of the relationship between constitutive-facultative skin color and phototype in Caucasians. Photochem Photobiol. 1999 Sep;70(3):303-7. |
| 10457139 | Background | Park SB, Suh DH, Youn JI. A long-term time course of colorimetric evaluation of ultraviolet light-induced skin reactions. Clin Exp Dermatol. 1999 Jul;24(4):315-20. doi: 10.1046/j.1365-2230.1999.00488.x. |
| 8784989 | Background | Trujillo O, Vanezis P, Cermignani M. Photometric assessment of skin colour and lightness using a tristimulus colorimeter: reliability of inter and intra-investigator observations in healthy adult volunteers. Forensic Sci Int. 1996 Jul 31;81(1):1-10. doi: 10.1016/0379-0738(96)01939-1. |
| 8785175 | Background | Maeda M, Kachi H, Matubara K, Mori S, Kitajima Y. Pigmentation abnormalities in systemic scleroderma examined by using a colorimeter (Choromo Meter CR-200). J Dermatol Sci. 1996 Mar;11(3):228-33. doi: 10.1016/0923-1811(95)00446-7. |
| 11459426 | Background | Wu H, Wang H, Li H, Oshuaakey J, Xiao F, Ke Y, Xu H, Xiao J, Lu D, Parra E, Shriver M, Xiong M, Barton SA, Hewett-Emmett D, Liu W, Ji L. Skin reflectance in the Han Chinese and Tibetan populations. Hum Biol. 2001 Jun;73(3):461-6. doi: 10.1353/hub.2001.0043. |
| 11301642 | Background | Van den Kerckhove E, Staes F, Flour M, Stappaerts K, Boeckx W. Reproducibility of repeated measurements on healthy skin with Minolta Chromameter CR-300. Skin Res Technol. 2001 Feb;7(1):56-9. doi: 10.1034/j.1600-0846.2001.007001056.x. |
| 12060473 | Background | Takiwaki H, Miyaoka Y, Skrebova N, Kohno H, Arase S. Skin reflectance-spectra and colour-value dependency on measuring-head aperture area in ordinary reflectance spectrophotometry and tristimulus colourimetry. Skin Res Technol. 2002 May;8(2):94-7. doi: 10.1034/j.1600-0846.2001.80206.x. |
| 19000184 | Background | Lee JA, Osmanovic S, Viana MA, Kapur R, Meghpara B, Edward DP. Objective measurement of periocular pigmentation. Photodermatol Photoimmunol Photomed. 2008 Dec;24(6):285-90. doi: 10.1111/j.1600-0781.2008.00377.x. |
| Withdrawal by Subject |
|
| BG002 | Travatan | Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Lumigan | Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s). |
| OG001 | Xalatan | Participants were assigned to use Xalatan ophthalmic solution one drop qhs for one year in affected eye(s). |
| OG002 | Travatan | Participants were assigned to use Travatan ophthalmic solution one drop qhs for one year in affected eye(s). |
|
|
|
| 0 |
| 32 |
| 1 |
| 32 |
| EG001 | Xalatan | Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s) | 0 | 29 | 0 | 29 |
| EG002 | Travatan | Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s) | 0 | 28 | 0 | 28 |
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| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |