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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01814761
• Collaborator: (none)
• Enrollment: 312
• Location: 1
• Duration (Months): 15
• Patients Per Site Per Month: 20.8

Study Details

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	Phase
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 1, 2013
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	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 Names: 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 Names: Lumigan® 0.01%

Outcome Measures

Primary Outcome Measures

1. Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1		Taichung City		Taiwan

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01814761
• Other Study ID Numbers: GMA-AP-EYE-AGN-001
• First Posted: Mar 20, 2013
• Last Update Posted: Oct 26, 2015
• Last Verified: Sep 1, 2015

• Additional relevant MeSH terms: Ocular Hypertension; Glaucoma, Open-Angle; Bimatoprost

Study Results

Participant Flow

Arm/Group Title	Pts With POAG or OH (Previously Treatment Naive)	Pts With POAG or OH (Switched Monotherapy)
Arm/Group Description	Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).	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%).
Period Title: Overall Study
STARTED	42	270
COMPLETED	34	240
NOT COMPLETED	8	30

Baseline Characteristics

Arm/Group Title	Pts With POAG or OH (Previously Treatment Naive)	Pts With POAG or OH (Switched Monotherapy)	Total
Arm/Group Description	Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).	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%).	Total of all reporting groups
Overall Participants	42	270	312
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	52.5 (13.65)	53.4 (14.45)	53.3 (14.33)
Sex: Female, Male (Count of Participants)
Female	20 47.6%	114 42.2%	134 42.9%
Male	22 52.4%	156 57.8%	178 57.1%

Outcome Measures

1. Secondary Outcome

Title	Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
Description	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).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment

Arm/Group Title	Pts With POAG or OH (Previously Treatment Naive)	Pts With POAG or OH (Switched Monotherapy)
Arm/Group Description	Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).	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%).
Measure Participants	42	270
Baseline	18.0 (3.82)	17.8 (3.89)
Week 12 (N=34, 240)	-3.6 (3.55)	-2.6 (3.22)

2. Secondary Outcome

Title	Percentage of Patients Who Discontinue Due to an Adverse Event
Description	An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related.
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment

Arm/Group Title	Pts With POAG or OH (Previously Treatment Naive)	Pts With POAG or OH (Switched Monotherapy)
Arm/Group Description	Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).	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%).
Measure Participants	42	270
Number [Percentage of Patients]	14.3	5.6

3. Primary Outcome

Title	Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
Description	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.
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment

Arm/Group Title	Pts With POAG or OH (Previously Treatment Naive)	Pts With POAG or OH (Switched Monotherapy)
Arm/Group Description	Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).	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%).
Measure Participants	42	270
None	7	36
Trace	10	50
Mild	12	84
Moderate	5	59
Severe	0	11
Missing	8	30

4. Secondary Outcome

Title	Overall Percent Change From Baseline in IOP
Description	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).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment

Arm/Group Title	Pts With POAG or OH (Previously Treatment Naive)	Pts With POAG or OH (Switched Monotherapy)
Arm/Group Description	Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).	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%).
Measure Participants	34	240
Mean (95% Confidence Interval) [Percentage Change]	-19.25	-13.26

Adverse Events

Adverse Event Reporting Description	The Safety Population is used to assess serious adverse events (SAEs) and adverse events (AEs) and included all enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment (same as the intent-to-treat population)
Arm/Group Title	Pts With POAG or OH (Previously Treatment Naive)		Pts With POAG or OH (Switched Monotherapy)
Arm/Group Description	Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).		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%).
All Cause Mortality
	Pts With POAG or OH (Previously Treatment Naive)		Pts With POAG or OH (Switched Monotherapy)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pts With POAG or OH (Previously Treatment Naive)		Pts With POAG or OH (Switched Monotherapy)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/42 (2.4%)		2/270 (0.7%)
Infections and infestations
Urinary Tract Infection	0/42 (0%)		1/270 (0.4%)
Injury, poisoning and procedural complications
Fall	0/42 (0%)		1/270 (0.4%)
Traumatic Intracranial Haemorrhage	1/42 (2.4%)		0/270 (0%)
Other (Not Including Serious) Adverse Events
	Pts With POAG or OH (Previously Treatment Naive)		Pts With POAG or OH (Switched Monotherapy)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/42 (23.8%)		16/270 (5.9%)
Eye disorders
Ocular Hyperaemia	7/42 (16.7%)		14/270 (5.2%)
Dry Eye	3/42 (7.1%)		2/270 (0.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.