Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01157364




Registration number
NCT01157364
Ethics application status
Date submitted
2/07/2010
Date registered
7/07/2010
Date last updated
30/03/2020

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/Phase 2
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
This study will evaluate the safety and efficacy of new ophthalmic formulations of
bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose
strengths will be evaluated based on internal data review of each cohort. The study was
planned to be conducted in 2 stages. Stage 1 was an open-label and Stage 2 was planned to be
masked; however only Stage 1 was conducted.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01157364
Trial related presentations / publications
Craven ER, Walters T, Christie WC, Day DG, Lewis RA, Goodkin ML, Chen M, Wangsadipura V, Robinson MR, Bejanian M; Bimatoprost SR Study Group. 24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients. Drugs. 2020 Feb;80(2):167-179. doi: 10.1007/s40265-019-01248-0.
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