Back to resultsOcular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension
Primary Purpose
Glaucoma, Open-Angle, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
bimatoprost ophthalmic solution 0.01%
travoprost ophthalmic solution 0.004%
latanoprost ophthalmic solution 0.005%
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
bimatoprost ophthalmic solution 0.01%
travoprost ophthalmic solution 0.004%
latanoprost ophthalmic solution 0.005%
Arm Description
One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01253902
Brief Title
Ocular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bimatoprost ophthalmic solution 0.01%
Arm Type
Active Comparator
Arm Description
One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
Arm Title
travoprost ophthalmic solution 0.004%
Arm Type
Active Comparator
Arm Description
One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
Arm Title
latanoprost ophthalmic solution 0.005%
Arm Type
Active Comparator
Arm Description
One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
bimatoprost ophthalmic solution 0.01%
Other Intervention Name(s)
Lumigan® 0.01%, Lumigan® RC
Intervention Description
One drop of bimatoprost ophthalmic solution 0.01% administered to affected eye(s), once daily in the evening for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
travoprost ophthalmic solution 0.004%
Other Intervention Name(s)
Travatan Z®
Intervention Description
One drop of travoprost ophthalmic solution 0.004% administered to affected eye(s), once daily in the evening for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
latanoprost ophthalmic solution 0.005%
Other Intervention Name(s)
Xalatan®
Intervention Description
One drop of latanoprost ophthalmic solution 0.005% administered to affected eye(s), once daily in the evening for 12 weeks.
Primary Outcome Measure Information:
Title
Mean Conjunctival Hyperemia at Week 12
Description
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).
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Mean Corneal Staining With Fluorescein at Week 12
Description
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).
Time Frame
Week 12
Title
Mean Tear Break Up Time (TBUT) at Week 12
Description
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.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Rogers
State/Province
Arkansas
Country
United States
City
Calgary
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
24006861
Citation
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.
Results Reference
derived
PubMed Identifier
23475405
Citation
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.
Results Reference
derived
Learn more about this trial
Ocular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension
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