Ocular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension

This study evaluated the ocular surface tolerability of the prostaglandin analogues bimatoprost ophthalmic solution 0.01% (Lumigan® 0.01%), travoprost ophthalmic solution 0.004% (Travatan Z®) and latanoprost ophthalmic solution 0.005% (Xalatan®) in patients previously treated with Xalatan® who have open-angle glaucoma or ocular hypertension.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma, Open-Angle
• Intervention / Treatment: Drug: bimatoprost ophthalmic solution 0.01%; Drug: travoprost ophthalmic solution 0.004%; Drug: latanoprost ophthalmic solution 0.005%

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
• United States
  • Arkansas
    • Rogers, Arkansas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of ocular hypertension or open-angle glaucoma in at least 1 eye requiring treatment with an anti-glaucoma/ocular hypertensive medication
• Best corrected visual acuity score of 20/100 or better in both eyes
• Females on birth control pills must be on same type of pill and dose for at least 3 month

Exclusion Criteria:

• Use of Lumigan® 0.01%/Lumigan® RC, Lumigan®, Travatan® or Travatan Z® within 6 months
• History of or active ocular infection/inflammation (eg, uveitis)
• Punctal plug use
• Required use of ocular medications during the study other than study medication (intermittent use of certain types artificial tears acceptable)
• Intraocular surgery or glaucoma laser surgery in study eye(s) within 3 months
• History of corneal refractive laser surgery (eg, LASIK, LASEK) in study eye(s)
• Planned contact lens wear during study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: bimatoprost ophthalmic solution 0.01%; One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.	Drug: bimatoprost ophthalmic solution 0.01%; One drop of bimatoprost ophthalmic solution 0.01% administered to affected eye(s), once daily in the evening for 12 weeks.; Other Names: Lumigan® 0.01%, Lumigan® RC
ACTIVE_COMPARATOR: travoprost ophthalmic solution 0.004%; One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.	Drug: travoprost ophthalmic solution 0.004%; One drop of travoprost ophthalmic solution 0.004% administered to affected eye(s), once daily in the evening for 12 weeks.; Other Names: Travatan Z®
ACTIVE_COMPARATOR: latanoprost ophthalmic solution 0.005%; One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.	Drug: latanoprost ophthalmic solution 0.005%; One drop of latanoprost ophthalmic solution 0.005% administered to affected eye(s), once daily in the evening for 12 weeks.; Other Names: Xalatan®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Conjunctival Hyperemia at Week 12	Conjunctival hyperemia was analyzed using the average of the scores of both eyes. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness).	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Corneal Staining With Fluorescein at Week 12	Corneal staining was analyzed using the average of the scores of both eyes. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0=None (no puncta), 0.5=Trace (1-5 puncta), 1=Mild (6-20 puncta), 2=Moderate (>20 puncta) and 3=Severe (too many puncta to count).	Week 12
Mean Tear Break Up Time (TBUT) at Week 12	Tear Break Up Time was analyzed using the average of the readings of both eyes. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.	Week 12

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• Schwartz GF, Hollander DA, Williams JM. Evaluation of eye drop administration technique in patients with glaucoma or ocular hypertension. Curr Med Res Opin. 2013 Nov;29(11):1515-22. doi: 10.1185/03007995.2013.833898. Epub 2013 Sep 5.
• Crichton AC, Vold S, Williams JM, Hollander DA. Ocular surface tolerability of prostaglandin analogs and prostamides in patients with glaucoma or ocular hypertension. Adv Ther. 2013 Mar;30(3):260-70. doi: 10.1007/s12325-013-0014-7. Epub 2013 Mar 7.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: December 2, 2010
• First Submitted That Met QC Criteria: December 3, 2010
• First Posted (ESTIMATE): December 6, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 7, 2012
• Last Update Submitted That Met QC Criteria: October 8, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost; Bimatoprost; Latanoprost
• Other Study ID Numbers: GMA-LUM-09-014