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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01253902
First Posted: December 6, 2010
Last Update Posted: November 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  Purpose
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.

Condition Intervention Phase
Glaucoma, Open-Angle Ocular Hypertension Drug: bimatoprost ophthalmic solution 0.01% Drug: travoprost ophthalmic solution 0.004% Drug: latanoprost ophthalmic solution 0.005% Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Mean Conjunctival Hyperemia at Week 12 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 164
Study Start Date: December 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Xalatan®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253902


Locations
United States, Arkansas
Rogers, Arkansas, United States
Canada, Alberta
Calgary, Alberta, Canada
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01253902     History of Changes
Other Study ID Numbers: GMA-LUM-09-014
First Submitted: December 2, 2010
First Posted: December 6, 2010
Results First Submitted: October 8, 2012
Results First Posted: November 7, 2012
Last Update Posted: November 7, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Latanoprost
Bimatoprost
Travoprost
Antihypertensive Agents