Trial Outcomes & Findings for The Effects of Xalatan, Travatan and Lumigan on Skin Pigmentation Near the Eye (NCT NCT00705757)

NCT ID: NCT00705757

Last Updated: 2016-01-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 89 participants
• Primary outcome timeframe: one year
• Results posted on: 2016-01-18

Participant Flow

Participant milestones

Measure	Lumigan Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)	Xalatan Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)	Travatan Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
Overall Study STARTED	32	29	28
Overall Study COMPLETED	19	21	17
Overall Study NOT COMPLETED	13	8	11

Reasons for withdrawal

Measure	Lumigan Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)	Xalatan Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)	Travatan Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
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

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

Baseline characteristics by cohort

Measure	Lumigan n=19 Participants Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)	Xalatan n=21 Participants Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)	Travatan n=17 Participants Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)	Total n=57 Participants Total of all reporting groups
Age, Continuous	61.5 years n=5 Participants	59.2 years n=7 Participants	60.5 years n=5 Participants	60.4 years n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	27 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	13 Participants n=7 Participants	8 Participants n=5 Participants	30 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	19 Participants n=7 Participants	13 Participants n=5 Participants	47 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: one year

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

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.

Outcome measures

Measure	Lumigan n=19 Participants Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s).	Xalatan n=21 Participants Participants were assigned to use Xalatan ophthalmic solution one drop qhs for one year in affected eye(s).	Travatan n=17 Participants Participants were assigned to use Travatan ophthalmic solution one drop qhs for one year in affected eye(s).
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	-1.42 L*a*b* Standard Error 0.57	-0.90 L*a*b* Standard Error 0.53
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 0.30	0.48 L*a*b* Standard Error 0.40	0.17 L*a*b* Standard Error 0.40
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	0.55 L*a*b* Standard Error 0.33	0.51 L*a*b* Standard Error 0.41

Adverse Events

Lumigan

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Xalatan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Travatan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lumigan n=32 participants at risk Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)	Xalatan n=29 participants at risk Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)	Travatan n=28 participants at risk Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
Eye disorders Recurrence of iritis at 6 week visit	3.1% 1/32 • Data was collected for one year.	0.00% 0/29 • Data was collected for one year.	0.00% 0/28 • Data was collected for one year.

Additional Information

Deepak P. Edward, MD

Summa Health System ( at the time of the trial)

Phone: 330-780-0399

Email: deepak.edward@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place