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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01253902
First received: December 2, 2010
Last updated: October 8, 2012
Last verified: October 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Allergan

Additional 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
Study First Received: December 2, 2010
Results First Received: October 8, 2012
Last Updated: October 8, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Bimatoprost
Cloprostenol
Latanoprost
Ophthalmic Solutions
Pharmaceutical Solutions
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Contraceptive Agents
Contraceptive Agents, Female
Luteolytic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014