GlaucomaPhase 4NCT00705757

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

A Phase 4 study testing latanoprost, bimatoprost and travoprost in people with Glaucoma and Application Site Pigmentation Changes, run by Summa Health System at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Glaucoma, Application Site Pigmentation Changes
What is being tested?: latanoprost, bimatoprost and travoprost
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 89 participants
Where: 2 sitesUnited States
Study dates: Mar 2008to Apr 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Summa Health System
Akron, Ohio, 44304
Arlington Eye Physicians
Arlington Heights, Illinois, 60005

Other trials in United States

About this study

Official title: The Effects of Latanoprost, Bimatoprost and Travoprost on Periocular Skin Pigmentation

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.

Read the 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.

Conditions: Glaucoma, Application Site Pigmentation Changes
Being tested: latanoprost, bimatoprost, travoprost
Keywords: periocular skin pigmentation, Lumigan, Travatan, Xalatan, latanoprost, bimatoprost, travoprost
Medical subject headings: Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

latanoprostDrug
Also called Xalatan 0.005%
Xalatan/latanoprost 0.005% ophthalmic solution one drop qhs for one year
bimatoprostDrug
Also called Lumigan 0.03%
Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year
travoprostDrug
Also called Travatan 0.004%
Travatan/travoprost 0.004% ophthalmic solution one drop qhs for one year

Study groups in NCT00705757
Study group	Role	What they receive
Lumigan	Active comparator	Patients assigned to Lumigan/bimatoprost one drop before bedtime (qhs) to affected eye(s) Receives: Drug: bimatoprost
Xalatan	Active comparator	Patients assigned to Xalatan/latanoprost one drop before bedtime (qhs) to affected eye(s) Receives: Drug: latanoprost
Travatan	Active comparator	Patients assigned to Travatan/travoprost one drop before bedtime (qhs) to affected eye(s) Receives: Drug: travoprost

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Apr 2011

First posted26 Jun 2008 (estimated)
Study startMar 2008
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (29)Papers the sponsor has linked to this study.
Other trials for GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00705757
Sponsor's protocol ID: Pfizer GA6111AX
Status last verified: Dec 2015
First submitted: 24 Jun 2008
Last updated: 18 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 15534130
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.
PubMed 12719085
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.
PubMed 10926995
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.
PubMed 11296032
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.
PubMed 16286616
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.
PubMed 16935336
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.
PubMed 9154289
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.
PubMed 10726794
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.
PubMed 15288975
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.
PubMed 15249358
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.
PubMed 9692029
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.
PubMed 11584340
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.
PubMed 10897347
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.
PubMed 11174377
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.
PubMed 8896947

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Latanoprost, Bimatoprost and Travoprost on Periocular Skin Pigmentation
ClinicalTrials.gov ID: NCT00705757
Acronym / sponsor ID: Pfizer GA6111AX
Conditions: Glaucoma, Application Site Pigmentation Changes
Keywords: periocular skin pigmentation, Lumigan, Travatan, Xalatan, latanoprost, bimatoprost, travoprost
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Summa Health SystemUniversity, hospital or other
Study start: Mar 2008
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 26 Jun 2008 (estimated)
Results: Posted 18 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Lumigan	Active comparator	Drug: bimatoprostPatients assigned to Lumigan/bimatoprost one drop before bedtime (qhs) to affected eye(s)
Xalatan	Active comparator	Drug: latanoprostPatients assigned to Xalatan/latanoprost one drop before bedtime (qhs) to affected eye(s)
Travatan	Active comparator	Drug: travoprostPatients assigned to Travatan/travoprost one drop before bedtime (qhs) to affected eye(s)

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
latanoprostAlso: Xalatan 0.005%Xalatan/latanoprost 0.005% ophthalmic solution one drop qhs for one year	Drug	Xalatan
bimatoprostAlso: Lumigan 0.03%Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year	Drug	Lumigan
travoprostAlso: Travatan 0.004%Travatan/travoprost 0.004% ophthalmic solution one drop qhs for one year	Drug	Travatan

Primary outcome

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.
Time frame: 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.

Results and safety

Results posted to the registry on 18 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lumigan	32	19
Xalatan	29	21
Travatan	28	17

Primary outcome: 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.

Time frame: one year. Mean (Standard Error). Unit: L*a*b*

Measure	Lumigan n = 19	Xalatan n = 21	Travatan n = 17
Upper Lid	-0.90 (0.67)	-1.42 (0.57)	-0.90 (0.53)
Lower Lid	-0.37 (0.30)	0.48 (0.40)	0.17 (0.40)
Cheek/Face	0.30 (0.29)	0.55 (0.33)	0.51 (0.41)

Lumigan vs Xalatan vs Travatan: p = 0.769, ANOVA
Lumigan vs Xalatan vs Travatan: p = 0.230, ANOVA
Lumigan vs Xalatan vs Travatan: p = 0.851, ANOVA

Population analysed: Newly diagnosed glaucoma and ocular hypertension, males and females, age 30 and up, Caucasians and African Americans.

Adverse events

Time frame: Data was collected for one year.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lumigan	0 of 32 (0%)	1 of 32 (3.1%)	Not reported
Xalatan	0 of 29 (0%)	0 of 29 (0%)	Not reported
Travatan	0 of 28 (0%)	0 of 28 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15534130Albert 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.
Background: PubMed 12719085Herndon 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.
Background: PubMed 10926995Kook 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.
Background: PubMed 11296032Wand 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.
Background: PubMed 16286616Kapur 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.
Background: PubMed 16935336Doshi 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.
Background: PubMed 9154289Wistrand 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.
Background: PubMed 10726794Alm 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.
Background: PubMed 15288975McCarey 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.
Background: PubMed 15249358Alm 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.
Background: PubMed 9692029German 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.
Background: PubMed 11584340Takamoto 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Deepak P Edward, MD principal investigator

Summa Health System

Smajo Osmanovic, MD principal investigator

Arlington eye Associates

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing latanoprost, bimatoprost and travoprost in people with Glaucoma and Application Site Pigmentation Changes, run by Summa Health System at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00705757, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2016.