A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00538304
• Collaborator: (none)
• Enrollment: 222
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 37.1

Study Details

Study Description

Brief Summary

A one month study which will determine the safety and efficacy of bimatoprost eye drops in patients with glaucoma or ocular hypertension

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Ocular Hypertension	Drug: bimatoprost eye drops; Drug: placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 222 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 bimatoprost eye drops	Drug: bimatoprost eye drops; 1 drop in each eye daily for 1 month
Placebo Comparator: 2 placebo	Drug: placebo; 1 drop in each eye daily for 1 month

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1 [Baseline, Month 1]

   Change from Baseline in macroscopic conjunctival hyperemia (or visible eye redness). Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient's visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). The peak change is calculated for each eye by subtracting the largest score across the hourly measurements at baseline from the largest score across the hourly measurements at month 1. A positive number severity grade change from baseline indicated an increase in redness.

Secondary Outcome Measures

1. Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1 [Month 1]

   Percentage of patients with a >= 1 unit increase in macroscopic conjunctival hyperemia in either eye at the Month 1, 8 AM time point. Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient's visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe).

2. Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1 [Baseline, Month 1]

   Change from baseline in mean (average) IOP at Month 1 8 AM timepoint. IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.

3. Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1 [Month 1]

   Percentage of physicians who were very or extremely willing to continue patient on drug if drug were marketed based on their reported response to the question. Physicians were asked "Overall, based on how well this drug lowered THIS patient's IOP, balanced with any adverse events she/he may have experienced, would you consider continuing THIS medication (if the drug was marketed)?". The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, physician was asked for reason.

4. Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1 [Month 1]

   Percentage of patients who were very or extremely willing to continue to use this glaucoma medication based on their reported response to the question. Patients were asked "Overall, based on how well this drug lowered your IOP, your concern about the preservation of your vision, balanced with any side effects you may have experienced using your medication, would you be willing to continue this medication (eye drops) if your physician prescribed it?". The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, patient was asked for reason.

5. Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1 [Month 1]

   Percentage of patients who reported no change in the appearance of their eyes since the beginning of the study. Patients were asked "Are you experiencing a change in how your eye looks now since you began your current glaucoma medication?". The responses were yes or no. If yes, patient was asked for primary reason and if better, worse or as expected based on what the doctor's office told them to expect.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Chronic glaucoma or ocular hypertension

• IOP controlled on Xalatan

Exclusion Criteria:

• Uncontrolled medical conditions

• Known hypersensitivity to study medications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Atlanta	Georgia	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

• Craven ER, Liu CC, Batoosingh A, Schiffman RM, Whitcup SM. A randomized, controlled comparison of macroscopic conjunctival hyperemia in patients treated with bimatoprost 0.01% or vehicle who were previously controlled on latanoprost. Clin Ophthalmol. 2010 Dec 6;4:1433-40. doi: 10.2147/OPTH.S14915.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT00538304
• Other Study ID Numbers: 192024-035
• First Posted: Oct 2, 2007
• Last Update Posted: Apr 23, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Hypertension; Bimatoprost; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	Bimatoprost Eye Drops	Placebo
Arm/Group Description	Bimatoprost eye drops	Placebo
Period Title: Overall Study
STARTED	151	71
COMPLETED	144	66
NOT COMPLETED	7	5

Baseline Characteristics

Arm/Group Title	Bimatoprost Eye Drops	Placebo	Total
Arm/Group Description	Bimatoprost eye drops	Placebo	Total of all reporting groups
Overall Participants	151	71	222
Age, Customized (participants) [Number]
< 45 years	9 6%	2 2.8%	11 5%
Between 45 and 65 years	66 43.7%	32 45.1%	98 44.1%
> 65 years	76 50.3%	37 52.1%	113 50.9%
Sex: Female, Male (Count of Participants)
Female	91 60.3%	44 62%	135 60.8%
Male	60 39.7%	27 38%	87 39.2%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1
Description	Change from Baseline in macroscopic conjunctival hyperemia (or visible eye redness). Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient's visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). The peak change is calculated for each eye by subtracting the largest score across the hourly measurements at baseline from the largest score across the hourly measurements at month 1. A positive number severity grade change from baseline indicated an increase in redness.
Time Frame	Baseline, Month 1

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.

Arm/Group Title	Bimatoprost Eye Drops	Placebo
Arm/Group Description	Bimatoprost eye drops	Placebo
Measure Participants	147	71
Baseline	0.32 (0.280)	0.30 (0.288)
Month 1	0.18 (0.456)	0.02 (0.321)

2. Secondary Outcome

Title	Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1
Description	Percentage of patients with a >= 1 unit increase in macroscopic conjunctival hyperemia in either eye at the Month 1, 8 AM time point. Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient's visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe).
Time Frame	Month 1

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.

Arm/Group Title	Bimatoprost Eye Drops	Placebo
Arm/Group Description	Bimatoprost eye drops	Placebo
Measure Participants	147	71
Number [Percentage of Patients]	8.16	1.41

3. Secondary Outcome

Title	Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1
Description	Change from baseline in mean (average) IOP at Month 1 8 AM timepoint. IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.
Time Frame	Baseline, Month 1

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.

Arm/Group Title	Bimatoprost Eye Drops	Placebo
Arm/Group Description	Bimatoprost eye drops	Placebo
Measure Participants	147	71
Baseline, 8AM	18.2 (3.13)	18.0 (3.34)
Month 1, 8AM	-1.0 (2.64)	3.6 (3.85)

4. Secondary Outcome

Title	Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1
Description	Percentage of physicians who were very or extremely willing to continue patient on drug if drug were marketed based on their reported response to the question. Physicians were asked "Overall, based on how well this drug lowered THIS patient's IOP, balanced with any adverse events she/he may have experienced, would you consider continuing THIS medication (if the drug was marketed)?". The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, physician was asked for reason.
Time Frame	Month 1

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.

Arm/Group Title	Bimatoprost Eye Drops	Placebo
Arm/Group Description	Bimatoprost eye drops	Placebo
Measure Participants	147	71
Number [Percentage of Physicians]	85.7	39.5

5. Secondary Outcome

Title	Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1
Description	Percentage of patients who were very or extremely willing to continue to use this glaucoma medication based on their reported response to the question. Patients were asked "Overall, based on how well this drug lowered your IOP, your concern about the preservation of your vision, balanced with any side effects you may have experienced using your medication, would you be willing to continue this medication (eye drops) if your physician prescribed it?". The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, patient was asked for reason.
Time Frame	Month 1

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.

Arm/Group Title	Bimatoprost Eye Drops	Placebo
Arm/Group Description	Bimatoprost eye drops	Placebo
Measure Participants	147	71
Number [Percentage of Patients]	88.5	52.9

6. Secondary Outcome

Title	Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1
Description	Percentage of patients who reported no change in the appearance of their eyes since the beginning of the study. Patients were asked "Are you experiencing a change in how your eye looks now since you began your current glaucoma medication?". The responses were yes or no. If yes, patient was asked for primary reason and if better, worse or as expected based on what the doctor's office told them to expect.
Time Frame	Month 1

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.

Arm/Group Title	Bimatoprost Eye Drops	Placebo
Arm/Group Description	Bimatoprost eye drops	Placebo
Measure Participants	147	71
Number [Percentage of Patients]	95.1	94.1

Adverse Events

Adverse Event Reporting Description	The safety population consisted of all patients who were randomized, received at least 1 dose of masked study medication and had at least 1 post-baseline visit.
Arm/Group Title	Bimatoprost Eye Drops		Placebo
Arm/Group Description	Bimatoprost eye drops		Placebo
All Cause Mortality
	Bimatoprost Eye Drops		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bimatoprost Eye Drops		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/150 (0%)		0/71 (0%)
Other (Not Including Serious) Adverse Events
	Bimatoprost Eye Drops		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/150 (6.7%)		2/71 (2.8%)
Eye disorders
Conjunctival hyperaemia	10/150 (6.7%)		2/71 (2.8%)

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