A Study of Bimatoprost 0.01% in the Clinical Setting (APPEAL-Taiwan)

• ClinicalTrials.gov Identifier: NCT01814761
• Recruitment Status: Completed
• First Posted: March 20, 2013
• Results First Posted: October 26, 2015
• Last Update Posted: October 26, 2015
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

Brief Summary:

This is a study of bimatoprost 0.01% (LUMIGAN® 0.01%) in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OH) who require further treatment for elevated intraocular pressure (IOP).

Condition or disease	Intervention/treatment
Glaucoma, Primary Open Angle; Ocular Hypertension	Drug: Bimatoprost 0.01%

Study Design

• Study Type: Observational
• Actual Enrollment: 312 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Study Start Date: May 2013
• Actual Primary Completion Date: August 2014
• Actual Study Completion Date: August 2014

Groups and Cohorts

Group/Cohort	Intervention/treatment
Pts with POAG or OH (Previously Treatment Naive); Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).	Drug: Bimatoprost 0.01%; One drop of bimatoprost 0.01% (Lumigan® 0.01%) in the affected eye(s) every evening for 12 weeks.; Other Name: Lumigan® 0.01%
Pts with POAG or OH (Switched Monotherapy); Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).	Drug: Bimatoprost 0.01%; One drop of bimatoprost 0.01% (Lumigan® 0.01%) in the affected eye(s) every evening for 12 weeks.; Other Name: Lumigan® 0.01%

Outcome Measures

Primary Outcome Measures :

1. Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale [ Time Frame: 12 Weeks ]
   Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5-point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of patients in each severity grade are presented.

Secondary Outcome Measures :

1. Change From Baseline in Intraocular Pressure (IOP) in the Study Eye [ Time Frame: Baseline, Week 12 ]
   IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).
2. Percentage of Patients Who Discontinue Due to an Adverse Event [ Time Frame: 12 Weeks ]
   An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related.
3. Overall Percent Change From Baseline in IOP [ Time Frame: Baseline, Week 12 ]
   IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement) and a positive number change response indicates an increase in IOP (worsening).

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Subjects with primary open-angle glaucoma or ocular hypertension

Criteria

Inclusion Criteria:

• Diagnosis of primary open-angle glaucoma or ocular hypertension
• Determined by the treating physician to require treatment with bimatoprost 0.01%.

Exclusion Criteria:

• Previous use of Lumigan® 0.01%

Contacts and Locations

Locations

Taiwan

Taichung City, Taiwan

Sponsors and Collaborators

Allergan

Investigators

• Study Director: Medical Director; Allergan

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chen YY, Wang TH, Liu C, Wu KY, Chiu SL, Simonyi S, Lu DW. Tolerability and efficacy of bimatoprost 0.01 % in patients with open-angle glaucoma or ocular hypertension evaluated in the Taiwanese clinical setting: the Asia Pacific Patterns from Early Access of Lumigan 0.01 % (APPEAL Taiwan) study. BMC Ophthalmol. 2016 Sep 15;16(1):162. doi: 10.1186/s12886-016-0338-6.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01814761
• Other Study ID Numbers: GMA-AP-EYE-AGN-001
• First Posted: March 20, 2013
• Results First Posted: October 26, 2015
• Last Update Posted: October 26, 2015
• Last Verified: September 2015

Additional relevant MeSH terms:

Ocular Hypertension; Glaucoma, Open-Angle; Glaucoma; Eye Diseases; Bimatoprost; Antihypertensive Agents