Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension - Full Text View

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT01298700

Purpose

This study will evaluate the long-term safety of bimatoprost 0.01% ophthalmic solution compared with bimatoprost 0.03% ophthalmic solution in patients with glaucoma or ocular hypertension.

Condition	Intervention	Phase
Glaucoma Ocular Hypertension	Drug: bimatoprost 0.01% ophthalmic solution Drug: bimatoprost 0.03% ophthalmic solution	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Bimatoprost

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Percentage of Patients Reporting One or More Treatment-Related Ocular Surface Adverse Events [ Time Frame: Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of Patients Reporting One or More Treatment-Related Ocular Surface Adverse Events excluding "Conjunctival Hyperemia" [ Time Frame: Month 24 ] [ Designated as safety issue: No ]

Estimated Enrollment:	784
Study Start Date:	April 2011
Estimated Study Completion Date:	August 2015
Estimated Primary Completion Date:	August 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 bimatoprost 0.01% ophthalmic solution	Drug: bimatoprost 0.01% ophthalmic solution One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years. Other Names: LUMIGAN® 0.01% LUMIGAN 0.1 mg/ml
Active Comparator: 2 bimatoprost 0.03% ophthalmic solution	Drug: bimatoprost 0.03% ophthalmic solution One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years Other Names: LUMIGAN® 0.03% LUMIGAN 0.3 mg/ml

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ocular hypertension or glaucoma in each eye
Requires intraocular pressure (IOP)-lowering therapy in both eyes
Best corrected visual acuity of 20/100 or better in each eye

Exclusion Criteria:

Ocular seasonal allergies within 2 years
Required chronic use of ocular medications during the study (intermittent use of artificial tears is allowed)
Ocular surgery or laser within 3 months
Anticipated wearing of contact lenses during the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298700

Contacts

Contact: Allergan Inc.

clinicaltrials@allergan.com

Locations

France
	Recruiting
Lyon, France
Germany
	Recruiting
Mainz, Rhineland-Palatinate, Germany
Israel
	Recruiting
Petach Tikva, Israel
Italy
	Recruiting
Milano, Italy
Poland
	Recruiting
Gdańsk, Poland
Spain
	Recruiting
Torrevieja, Alicante, Spain

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Additional Information:

More Information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01298700 History of Changes
Other Study ID Numbers:	192024-054
Study First Received:	February 16, 2011
Last Updated:	February 7, 2012
Health Authority:	Israel: Ministry of Health

Additional relevant MeSH terms:

Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Bimatoprost
Cloprostenol
Antihypertensive Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2012