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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01157364




Registration number
NCT01157364
Ethics application status
Date submitted
2/07/2010
Date registered
7/07/2010

Titles & IDs
Public title
Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension
Scientific title
An Open-label (Stage 1) and Randomized (Stage 2), 24 Month Study of Safety and Efficacy of Bimatoprost Drug Delivery System in Patients With Open-Angle Glaucoma or Ocular Hypertension
Secondary ID [1] 0 0
2011-005091-42
Secondary ID [2] 0 0
192024-041D
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Open-Angle Glaucoma 0 0
Ocular Hypertension 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - bimatoprost 20 µg generation 2
Treatment: Drugs - bimatoprost 15 µg generation 2
Treatment: Drugs - bimatoprost 10 µg generation 2
Treatment: Drugs - bimatoprost 6 µg generation 2
Treatment: Drugs - bimatoprost 15 µg generation 1
Treatment: Drugs - bimatoprost 10 µg generation 1
Treatment: Drugs - bimatoprost 0.03%

Other: bimatoprost 20 µg generation 2, bimatoprost 0.03% - Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

Other: bimatoprost 15 µg generation 2, bimatoprost 0.03% - Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

Other: bimatoprost 10 µg generation 2, bimatoprost 0.03% - Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

Other: bimatoprost 6 µg generation 2, bimatoprost 0.03% - Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

Other: bimatoprost 15 µg generation 1, bimatoprost 0.03% - Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

Other: bimatoprost 10 µg generation 1, bimatoprost 0.03% - Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.


Treatment: Drugs: bimatoprost 20 µg generation 2
Single dose of bimatoprost ophthalmic administered in the study eye on Day 1.

Treatment: Drugs: bimatoprost 15 µg generation 2
Single dose of bimatoprost ophthalmic administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).

Treatment: Drugs: bimatoprost 10 µg generation 2
Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).

Treatment: Drugs: bimatoprost 6 µg generation 2
Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).

Treatment: Drugs: bimatoprost 15 µg generation 1
Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.

Treatment: Drugs: bimatoprost 10 µg generation 1
Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1.

Treatment: Drugs: bimatoprost 0.03%
One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
Timepoint [1] 0 0
Baseline, Month 24
Secondary outcome [1] 0 0
Time-Matched Intraocular Pressure (IOP) in the Study Eye
Timepoint [1] 0 0
Baseline to Month 6
Secondary outcome [2] 0 0
Mean Diurnal IOP in the Study Eye
Timepoint [2] 0 0
Baseline, Month 6
Secondary outcome [3] 0 0
Time to Rescue Treatment or Re-Treatment in the Study Eye
Timepoint [3] 0 0
24 Months

Eligibility
Key inclusion criteria
* Diagnosis of open angle glaucoma or ocular hypertension
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Uncontrolled medical conditions
* Anticipated wearing of contact lenses during the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/08/2016
Sample size
Target
Accrual to date
Final
109
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Melbourne Eye Specialists - Fitzroy
Recruitment hospital [2] 0 0
Eye Associates - Sydney New South Wales
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
2000 - Sydney New South Wales
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Belgium
State/province [17] 0 0
Dienst Oogheelkunde
Country [18] 0 0
Brazil
State/province [18] 0 0
Sao Paulo
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
Nova Scotia
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Canada
State/province [23] 0 0
Vaughan
Country [24] 0 0
Germany
State/province [24] 0 0
Karlsruhe
Country [25] 0 0
Israel
State/province [25] 0 0
Rohovot
Country [26] 0 0
Israel
State/province [26] 0 0
Tel Aviv
Country [27] 0 0
Israel
State/province [27] 0 0
Tel-Hashomer
Country [28] 0 0
Philippines
State/province [28] 0 0
Makati City
Country [29] 0 0
Philippines
State/province [29] 0 0
Metro Manila
Country [30] 0 0
Singapore
State/province [30] 0 0
Singapore
Country [31] 0 0
Spain
State/province [31] 0 0
Sant Cugat
Country [32] 0 0
Spain
State/province [32] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01157364