Bimatoprost 0.03% Versus Travoprost 0.004% in Patients Currently on Latanoprost 0.005%

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00440011
• Collaborator: (none)
• Enrollment: 266
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 19

Study Details

Study Description

Brief Summary

Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering, will be randomized to receive either bimatoprost 0.03% or travoprost 0.004% in place of latanoprost 0.005%

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Ocular Hypertension	Drug: bimatoprost 0.03% eye drops; Drug: travoprost 0.004% eye drops	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 266 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: bimatoprost 0.03% eye drops; bimatoprost 0.03% 1 drop nightly for 3 months; Other Names: Lumigan®
Active Comparator: 2	Drug: travoprost 0.004% eye drops; travoprost 0.004% 1 drop nightly for 3 months; Other Names: Travatan®

Outcome Measures

Primary Outcome Measures

1. Intraocular Pressure (IOP) [Month 3]

   Intraocular Pressure

Secondary Outcome Measures

1. Tolerability - Conjunctival Hyperemia [Month 3]

   Conjunctival Hyperemia: Number of participants with at least 1 grade increase in severity from baseline. A five grade scale from 0 to 3 (0 = none, +0.5 = trace, 1 = mild, 2 = moderate, 3 = severe)

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Glaucoma or ocular hypertension in both eyes

• Currently being treated with latanoprost 0.005% daily and in need of additional IOP-lowering

• Best-corrected visual acuity of 20/100 or better in each eye

• Visual field within 6 months of study entry

Exclusion Criteria:

• Secondary glaucoma

• Active intraocular inflammation or macular edema

• Intraocular surgery or laser surgery within the past 3 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		San Diego	California	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Affairs, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

• Kammer JA, Katzman B, Ackerman SL, Hollander DA. Efficacy and tolerability of bimatoprost versus travoprost in patients previously on latanoprost: a 3-month, randomised, masked-evaluator, multicentre study. Br J Ophthalmol. 2010 Jan;94(1):74-9. doi: 10.1136/bjo.2009.158071. Epub 2009 Sep 1.

• ClinicalTrials.gov Identifier: NCT00440011
• Other Study ID Numbers: MA-LUM01
• First Posted: Feb 26, 2007
• Last Update Posted: Apr 25, 2019
• Last Verified: Apr 1, 2019

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

Study Results

Participant Flow

Arm/Group Title	Bimatoprost	Travoprost
Arm/Group Description	bimatoprost 0.03% 1 drop nightly for 3 months	travoprost 0.004% 1 drop nightly for 3 months
Period Title: Overall Study
STARTED	131	135
COMPLETED	127	132
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Bimatoprost	Travoprost	Total
Arm/Group Description	bimatoprost 0.03% 1 drop nightly for 3 months	travoprost 0.004% 1 drop nightly for 3 months	Total of all reporting groups
Overall Participants	131	135	266
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.4 (12.3)	62.7 (12.4)	63.0 (12.3)
Sex: Female, Male (Count of Participants)
Female	81 61.8%	66 48.9%	147 55.3%
Male	50 38.2%	69 51.1%	119 44.7%
Region of Enrollment (participants) [Number]
United States	131 100%	135 100%	266 100%

Outcome Measures

1. Primary Outcome

Title	Intraocular Pressure (IOP)
Description	Intraocular Pressure
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bimatoprost	Travoprost
Arm/Group Description	bimatoprost 0.03% 1 drop nightly for 3 months	travoprost 0.004% 1 drop nightly for 3 months
Measure Participants	127	132
Mean (Standard Deviation) [mm Hg]	17 (3.1)	17.5 (2.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bimatoprost, Travoprost
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.024
	Comments
	Method	ANCOVA
	Comments

2. Secondary Outcome

Title	Tolerability - Conjunctival Hyperemia
Description	Conjunctival Hyperemia: Number of participants with at least 1 grade increase in severity from baseline. A five grade scale from 0 to 3 (0 = none, +0.5 = trace, 1 = mild, 2 = moderate, 3 = severe)
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bimatoprost	Travoprost
Arm/Group Description	bimatoprost 0.03% 1 drop nightly for 3 months	travoprost 0.004% 1 drop nightly for 3 months
Measure Participants	127	132
Number [participants]	15 11.5%	22 16.3%

Adverse Events

Arm/Group Title	Bimatoprost		Travoprost
Arm/Group Description	bimatoprost 0.03% 1 drop nightly for 3 months		travoprost 0.004% 1 drop nightly for 3 months
All Cause Mortality
	Bimatoprost		Travoprost
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bimatoprost		Travoprost
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/131 (0.8%)		0/133 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/131 (0.8%)		0/133 (0%)
Other (Not Including Serious) Adverse Events
	Bimatoprost		Travoprost
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/131 (16%)		22/133 (16.5%)
Blood and lymphatic system disorders
Anaemia	0/131 (0%)		1/133 (0.8%)
Cardiac disorders
Palpitations	0/131 (0%)		1/133 (0.8%)
Ear and labyrinth disorders
Deafness	0/131 (0%)		1/133 (0.8%)
Eye disorders
Ocular Hyperaemia	4/131 (3.1%)		1/133 (0.8%)
Eye Pruritus	3/131 (2.3%)		1/133 (0.8%)
Conjunctival Hyperaemia	1/131 (0.8%)		2/133 (1.5%)
Punctate keratitis	1/131 (0.8%)		2/133 (1.5%)
Eye Irritation	2/131 (1.5%)		0/133 (0%)
Growth of Eyelashes	2/131 (1.5%)		0/133 (0%)
Visual Acuity Reduced	0/131 (0%)		2/133 (1.5%)
Abnormal Sensation in Eye	1/131 (0.8%)		0/133 (0%)
Eye Discharge	1/131 (0.8%)		0/133 (0%)
Eyelid Margin Crusting	0/131 (0%)		1/133 (0.8%)
Lenticular Opacities	0/131 (0%)		1/133 (0.8%)
Blepharitis	1/131 (0.8%)		1/133 (0.8%)
Gastrointestinal disorders
Diarrhoea	0/131 (0%)		1/133 (0.8%)
Stomach Discomfort	0/131 (0%)		1/133 (0.8%)
General disorders
Instillation Site Pruritus	0/131 (0%)		1/133 (0.8%)
Oedema Peripheral	0/131 (0%)		1/133 (0.8%)
Pain	1/131 (0.8%)		0/133 (0%)
Sensation of Foreign Body	0/131 (0%)		1/133 (0.8%)
Immune system disorders
Drug Hypersensitivity	0/131 (0%)		1/133 (0.8%)
Hypersensitivity	1/131 (0.8%)		0/133 (0%)
Infections and infestations
Conjunctivitis Viral	0/131 (0%)		1/133 (0.8%)
Nasopharyngitis	0/131 (0%)		1/133 (0.8%)
Sinusitis	1/131 (0.8%)		0/133 (0%)
Injury, poisoning and procedural complications
Foreign Body in Eye	1/131 (0.8%)		0/133 (0%)
Nervous system disorders
Headache	1/131 (0.8%)		0/133 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/131 (0.8%)		0/133 (0%)
Dyspnoea	1/131 (0.8%)		0/133 (0%)
Rhinorrhoea	0/131 (0%)		1/133 (0.8%)
Skin and subcutaneous tissue disorders
Dry Skin	1/131 (0.8%)		0/133 (0%)
Pigmentation Disorder	1/131 (0.8%)		0/133 (0%)
Rash	1/131 (0.8%)		0/133 (0%)
Vascular disorders
Hyperaemia	0/131 (0%)		1/133 (0.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only 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 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.