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Prostaglandin Analog

Bimatoprost SR for Open-Angle Glaucoma

Phase 3
Waitlist Available
Research Sponsored by Allergan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 24
Awards & highlights

Study Summary

This trial will compare the effects of two different treatments for people with glaucoma or high eye pressure who aren't well controlled by current medication.

Eligible Conditions
  • Open-Angle Glaucoma
  • Ocular Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in IOP at Week 12
Change from Baseline in IOP at Week 4
Change from Baseline in Intraocular Pressure (IOP) at Week 24
Secondary outcome measures
IOP change from baseline at Week 15
IOP change from baseline at Week 20
IOP change from baseline at Week 8
+7 more

Side effects data

From 2019 Phase 3 trial • 594 Patients • NCT02247804
38%
Conjunctival hyperaemia
16%
Foreign body sensation in eyes
15%
Eye irritation
15%
Eye pain
12%
Photophobia
10%
Corneal endothelial cell loss
10%
Conjunctival haemorrhage
10%
Iritis
9%
Hypertension
9%
Dry eye
8%
Punctate keratitis
7%
Intraocular pressure increased
7%
Nasopharyngitis
7%
Lacrimation increased
6%
Vision blurred
6%
Anterior chamber cell
6%
Corneal oedema
4%
Influenza
4%
Headache
2%
Visual field defect
1%
Trigeminal neuralgia
1%
Acute myocardial infarction
1%
Myocardial infarction
1%
Chest pain
1%
Haemorrhoids
1%
Umbilical hernia
1%
Cerebrovascular accident
1%
Pulmonary embolism
1%
Hiatus hernia
1%
Intraductal proliferative breast lesion
1%
Femur fracture
1%
Road traffic accident
1%
Clostridium difficile infection
1%
Lumbar spinal stenosis
1%
Embolic stroke
1%
Varicose vein
1%
Acute coronary syndrome
1%
Gastric ulcer
1%
Intestinal obstruction
1%
Iridocyclitis
1%
Cardiac arrest
1%
Small intestinal obstruction
1%
Cerebral haemorrhage
1%
Chondrocalcinosis pyrophosphate
1%
Renal failure
1%
Internal haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bimatoprost SR 15 μg
Bimatoprost SR 10 μg
Timolol 0.5%: Comparator

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Bimatoprost Sustained-Release (SR)Experimental Treatment4 Interventions
Assigned Primary Eye: Sham Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to two Bimatoprost SR Administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Contralateral Eye: SLT administered on Day 1 followed by up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).
Group II: Selective Laser Trabeculoplasty (SLT)Active Control4 Interventions
Assigned Primary Eye: SLT administered on Day 1 followed by up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Contralateral Eye: Sham Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to two Bimatoprost SR Administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sham Selective Laser Trabeculoplasty
2015
Completed Phase 3
~390
Bimatoprost SR
2014
Completed Phase 3
~1550
Sham Bimatoprost SR
2015
Completed Phase 3
~390
Selective Laser Trabeculoplasty
2015
Completed Phase 3
~1050

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
276,329 Total Patients Enrolled
AbbVieLead Sponsor
958 Previous Clinical Trials
502,144 Total Patients Enrolled
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
79,019 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many different hospitals is this clinical trial being offered?

"54 different sites are presently running this study. If you enroll, try and choose a location near to you from the list of Petaluma, Fort Myers, Phoenix or other locations to reduce travel time."

Answered by AI

How is Bimatoprost SR commonly employed?

"Bimatoprost SR can be used to ameliorate symptoms of open angle glaucoma, treat eyelash conditions, and help those with increased intra ocular pressure."

Answered by AI

What other scientific papers mention Bimatoprost SR in their research?

"The first study of bimatoprost SR was conducted in 2015 at Auckland Eye Hospital /ID# 235253. Since then, there have been 115 completed trials. Currently, 5 active clinical trials are underway, with a majority taking place in Petaluma, California."

Answered by AI

Is Bimatoprost SR an FDA-regulated medication?

"Bimatoprost SR has received a safety rating of 3. This is due to the fact that it is a Phase 3 trial, so there are multiple rounds of data supporting both efficacy and safety."

Answered by AI

What are the unique aspects of this clinical trial?

"Since 2015, when the first study occurred, there has been ongoing research into Bimatoprost SR. That initial trial was sponsored by Allergan and featured 215 participants. Once Phase 3 drug approval was received, 5 different trials began in 152 different cities across 31 countries."

Answered by AI

Are patients being enrolled in this study at this time?

"According to the website, this study is not currently looking for patients. The trial was first posted on 8/27/2015, and the most recent update was 11/1/2022. Although this particular clinical trial isn't recruiting right now, there are 980 other studies that are."

Answered by AI

How many people will be given the opportunity to participate in this research project?

"Recruitment for this clinical trial is currently inactive. However, the study was last edited on November 1st, 2022, so it may open up again in the future. If you are looking for other trials to participate in, there are 975 active clinical trials related to glaucoma and open-angle Bimatoprost SR."

Answered by AI

Who else is applying?

What state do they live in?
West Virginia
How old are they?
18 - 65
What site did they apply to?
West Virginia University Eye Institute /ID# 235174
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
2015. "Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02507687.
~25 spots leftby Apr 2025
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