Ocular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension
NCT ID: NCT01253902
Last Updated: 2012-11-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
164 participants
INTERVENTIONAL
2010-12-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Rogers, Arkansas, United States
Calgary, Alberta, Canada
Countries
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References
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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.
Other Identifiers
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GMA-LUM-09-014
Identifier Type: -
Identifier Source: org_study_id