The Effects of Xalatan, Travatan and Lumigan on Skin Pigmentation Near the Eye

NCT00705757 | Completed Phase 4 Results

• 1 other identifier: Pfizer GA6111AX
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 2

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.

Conditions

Glaucoma; Application Site Pigmentation Changes

Keywords

periocular skin pigmentation; Lumigan; Travatan; Xalatan; latanoprost; bimatoprost; travoprost

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Lumigan

ACTIVE COMPARATOR

Patients assigned to Lumigan/bimatoprost one drop before bedtime (qhs) to affected eye(s)

Drug: bimatoprost

Xalatan

ACTIVE COMPARATOR

Patients assigned to Xalatan/latanoprost one drop before bedtime (qhs) to affected eye(s)

Drug: latanoprost

Travatan

ACTIVE COMPARATOR

Patients assigned to Travatan/travoprost one drop before bedtime (qhs) to affected eye(s)

Drug: travoprost

Interventions

latanoprost DRUG

Xalatan/latanoprost 0.005% ophthalmic solution one drop qhs for one year

Also known as: Xalatan 0.005%

Xalatan

bimatoprost DRUG

Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year

Also known as: Lumigan 0.03%

Lumigan

travoprost DRUG

Travatan/travoprost 0.004% ophthalmic solution one drop qhs for one year

Also known as: Travatan 0.004%

Travatan

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients recently diagnosed with primary open angle glaucoma or ocular hypertension
• Caucasian and African American ethnicities
• Male and Female
• Age 30 and above

You may not qualify if:

• 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

Sponsors & Collaborators

• Summa Health System: lead

Study Sites (2)

Arlington Eye Physicians

Arlington Heights, Illinois, 60005, United States

Location

Summa Health System

Akron, Ohio, 44304, United States

Location

Related Publications (29)

• 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.

  PMID: 15534130 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.

  PMID: 12719085 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.

  PMID: 10926995 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.

  PMID: 11296032 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.

  PMID: 16286616 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.

  PMID: 16935336 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.

  PMID: 9154289 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.

  PMID: 10726794 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.

  PMID: 15288975 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.

  PMID: 15249358 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.

  PMID: 9692029 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.

  PMID: 11584340 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.

  PMID: 10897347 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.

  PMID: 11174377 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.

  PMID: 8896947 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.

  PMID: 8665445 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.

  PMID: 15291306 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.

  PMID: 15019115 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.

  PMID: 14535897 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.

  PMID: 11756647 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.

  PMID: 10906645 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.

  PMID: 10483358 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.

  PMID: 10457139 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.

  PMID: 8784989 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.

  PMID: 8785175 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.

  PMID: 11459426 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.

  PMID: 11301642 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.

  PMID: 12060473 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.

  PMID: 19000184 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Interventions

Latanoprost; Bimatoprost; Travoprost

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Amides; Organic Chemicals; Cloprostenol

Results Point of Contact

• Title: Deepak P. Edward, MD
• Organization: Summa Health System ( at the time of the trial)

deepak.edward@gmail.com

330-780-0399

Study Officials

• Deepak P Edward, MD

  Summa Health System

  PRINCIPAL INVESTIGATOR

• Smajo Osmanovic, MD

  Arlington eye Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 26, 2008
• Study Start: March 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: January 18, 2016
• Results First Posted: January 18, 2016

Record last verified: 2015-12

Locations

US (2)