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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02250651




Registration number
NCT02250651
Ethics application status
Date submitted
23/09/2014
Date registered
26/09/2014
Date last updated
28/07/2021

Titles & IDs
Public title
Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension
Scientific title
The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension
Secondary ID [1] 0 0
2014-003186-24
Secondary ID [2] 0 0
192024-092
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma, Open-Angle 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 SR
Other interventions - Sham: Applicator Without Needle
Treatment: Drugs - Active Comparator: Timolol 0.5%
Treatment: Drugs - Timolol Vehicle (placebo)

Experimental: Bimatoprost SR 15 µg - Study Eye: bimatoprost sustained-release (SR) 15 micrograms (µg) administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.

Experimental: Bimatoprost SR 10 µg - Study Eye: bimatoprost SR 10 µg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.

Active comparator: Timolol 0.5%: Comparator - Both Eyes: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.


Treatment: Drugs: Bimatoprost SR
Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.

Other interventions: Sham: Applicator Without Needle
Sham administered on Day 1, Week 16, and Week 32.

Treatment: Drugs: Active Comparator: Timolol 0.5%
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.

Treatment: Drugs: Timolol Vehicle (placebo)
Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2)
Timepoint [1] 0 0
Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2)
Primary outcome [2] 0 0
IOP in the Study Eye at Week 2 (Hour 0)
Timepoint [2] 0 0
Week 2 (Hour 0)
Primary outcome [3] 0 0
IOP in the Study Eye at Week 2 (Hour 2)
Timepoint [3] 0 0
Week 2 (Hour 2)
Primary outcome [4] 0 0
IOP in the Study Eye at Week 6 (Hour 0)
Timepoint [4] 0 0
Week 6 (Hour 0)
Primary outcome [5] 0 0
IOP in the Study Eye at Week 6 (Hour 2)
Timepoint [5] 0 0
Week 6 (Hour 2)
Primary outcome [6] 0 0
IOP in the Study Eye at Week 12 (Hour 0)
Timepoint [6] 0 0
Week 12 (Hour 0)
Primary outcome [7] 0 0
IOP in the Study Eye at Week 12 (Hour 2)
Timepoint [7] 0 0
Week 12 (Hour 2)
Secondary outcome [1] 0 0
Change From Baseline in IOP in the Study Eye
Timepoint [1] 0 0
Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)

Eligibility
Key inclusion criteria
- Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous enrollment in another Allergan Bimatoprost SR Study
* Eye surgery (including cataract surgery) and/or any eye laser surgery within the past 6 months in the study eye
* Anticipated need for laser eye surgery within the first 52 weeks of the study duration
* History of glaucoma surgery

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 3
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
15/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/07/2020
Sample size
Target
Accrual to date
Final
528
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
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United States of America
State/province [3] 0 0
Arkansas
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United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
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Illinois
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Missouri
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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North Carolina
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North Dakota
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Oregon
Country [20] 0 0
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Pennsylvania
Country [21] 0 0
United States of America
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Texas
Country [22] 0 0
United States of America
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Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Ciudad Autónoma de BuenosAires
Country [28] 0 0
Argentina
State/province [28] 0 0
Mendoza
Country [29] 0 0
Canada
State/province [29] 0 0
Alberta
Country [30] 0 0
Canada
State/province [30] 0 0
Nova Scotia
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Canada
State/province [31] 0 0
Ontario
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Canada
State/province [32] 0 0
Quebec
Country [33] 0 0
Colombia
State/province [33] 0 0
Antioquia
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Colombia
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Distrito Capital De Bogota
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Colombia
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Santander
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Colombia
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Cali
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Czechia
State/province [37] 0 0
Jihlavska
Country [38] 0 0
Czechia
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Sokolska
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Czechia
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Prague
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Egypt
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Cairo
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Germany
State/province [41] 0 0
Bayern
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen-Anhalt
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Germany
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Mainz
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Italy
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Abruzzo
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Italy
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Lombardia
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Italy
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Sicilia
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Italy
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Toscana
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Italy
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Milano
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Italy
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Perugia
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Korea, Republic of
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Seoul
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Malaysia
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Kuala Lumpur
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New Zealand
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Wellington
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Singapore
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Singapore
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South Africa
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Free State
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South Africa
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Pretoria
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Turkey
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Eskisehir
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Turkey
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Istanbul
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Turkey
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Manisa
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United Kingdom
State/province [60] 0 0
Cambridge
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United Kingdom
State/province [61] 0 0
Cosham
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United Kingdom
State/province [62] 0 0
Edinburgh
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United Kingdom
State/province [63] 0 0
Great Yarmouth
Country [64] 0 0
United Kingdom
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Liverpool
Country [65] 0 0
United Kingdom
State/province [65] 0 0
London
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Peterborough

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 efficacy and safety of bimatoprost sustained-release (SR) in patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.
Trial website
https://clinicaltrials.gov/study/NCT02250651
Trial related presentations / publications
Weinreb RN, Bacharach J, Brubaker JW, Medeiros FA, Bejanian M, Bernstein P, Robinson MR. Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies. J Ocul Pharmacol Ther. 2023 Jan-Feb;39(1):55-62. doi: 10.1089/jop.2022.0137. Epub 2022 Nov 15.
Medeiros FA, Sheybani A, Shah MM, Rivas M, Bai Z, Werts E, Ahmed IIK, Craven ER. Single Administration of Intracameral Bimatoprost Implant 10 microg in Patients with Open-Angle Glaucoma or Ocular Hypertension. Ophthalmol Ther. 2022 Aug;11(4):1517-1537. doi: 10.1007/s40123-022-00527-6. Epub 2022 May 28.
Bacharach J, Tatham A, Ferguson G, Belalcazar S, Thieme H, Goodkin ML, Chen MY, Guo Q, Liu J, Robinson MR, Bejanian M, Wirta DL; ARTEMIS 2 Study Group. Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2). Drugs. 2021 Nov;81(17):2017-2033. doi: 10.1007/s40265-021-01624-9. Epub 2021 Nov 1.
Public notes

Contacts
Principal investigator
Name 0 0
Margot Goodkin
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02250651