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Prostaglandin Analog

Long-term Safety and Efficacy of Bimatoprost SR for Glaucoma (Maia Trial)

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
Participants who completed 1 of the 4 Bimatoprost SR Phase 3 studies (192024-091, -092, -093, or -095) and received Bimatoprost SR.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 months
Awards & highlights

Maia Trial Summary

This trial will check the safety and effectiveness of Bimatoprost SR for people who have completed one of four other phase 3 studies on the drug.

Who is the study for?
This trial is for people who have high blood pressure in the eye, open-angle glaucoma, or ocular hypertension and were part of earlier Bimatoprost SR studies. They must not be pregnant, nursing, planning pregnancy without contraception, or unable to follow study requirements.Check my eligibility
What is being tested?
The long-term safety and effectiveness of Bimatoprost Sustained Release (SR) are being tested on patients with certain eye conditions who previously received this treatment during earlier phases of research.See study design
What are the potential side effects?
Possible side effects include red eyes, eye irritation or pain, darkening of the skin around the eyes, eyelash growth changes, and potential vision changes. Each person may experience side effects differently.

Maia Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I completed a Phase 3 study for Bimatoprost SR and received the treatment.

Maia Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of effect of Bimatoprost SR
Number of patients experiencing a treatment emergent adverse event

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%
Nasopharyngitis
7%
Intraocular pressure increased
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

Maia Trial Design

4Treatment groups
Experimental Treatment
Group I: Lead-in study ARGOSExperimental Treatment2 Interventions
Study eye (Eye that received Bimatoprost SR first in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Treated Fellow eye (Eye that received Bimatoprost SR second in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Untreated Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Untreated fellow eye will receive only standard of care, based on the investigator's judgment.
Group II: Lead-in study 192024-093 Stage 2Experimental Treatment2 Interventions
Participants who received 1 Bimatoprost administration due to sustained efficacy: Study eye (Eye that received Bimatoprost SR in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.
Group III: Lead-in study 192024-093 Stage 1Experimental Treatment1 Intervention
Participants who received 1, 2 or 3 administrations and participants in Stage 2 who received 1 Bimatoprost SR administration due to safety concern or received 2 administrations. Study eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.
Group IV: Lead-in study 192024-091 or -092 or -095Experimental Treatment1 Intervention
Study eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bimatoprost SR
2014
Completed Phase 3
~1550

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
275,969 Total Patients Enrolled
AbbVieLead Sponsor
954 Previous Clinical Trials
500,505 Total Patients Enrolled
Marina BejanianStudy DirectorAllergan
1 Previous Clinical Trials
594 Total Patients Enrolled

Media Library

Bimatoprost SR (Prostaglandin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT03891446 — Phase 3
Open-Angle Glaucoma Research Study Groups: Lead-in study 192024-093 Stage 2, Lead-in study 192024-093 Stage 1, Lead-in study ARGOS, Lead-in study 192024-091 or -092 or -095
Open-Angle Glaucoma Clinical Trial 2023: Bimatoprost SR Highlights & Side Effects. Trial Name: NCT03891446 — Phase 3
Bimatoprost SR (Prostaglandin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03891446 — Phase 3
Open-Angle Glaucoma Patient Testimony for trial: Trial Name: NCT03891446 — Phase 3

Frequently Asked Questions

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

Does this trial explore a new treatment method?

"At this moment, there are 5 on-going trials for Bimatoprost SR in 31 countries and 152 cities. The first trial was completed in 2015 by Allergan. That particular study had 215 participants and successfully completed Phase 3 drug approval. Since then, 338 similar trials have been carried out."

Answered by AI

Are there any other published reports on Bimatoprost SR's effects?

"The first study for bimatoprost SR was in 2015 at the Auckland Eye Hospital. As of now, there are a total of 338 completed studies and 5 trials that are actively recruiting patients. Many of these studies take place in Halifax, Nova Scotia."

Answered by AI

In how many facilities is this trial being carried out?

"There are 100 medical facilities around the world participating in this study, such as Dalhousie University in Halifax, Specialty Retina Center in Weston, Montefiore Medical Center in Bronx, and 97 other locations."

Answered by AI

Are there any severe side effects to Bimatoprost SR?

"Bimatoprost SR is considered safe according to our team's estimation. This safety score of 3 was given because this drug is currently in Phase 3 trials, meaning that there is some evidence supporting its efficacy as well as multiple rounds of data affirming its safety."

Answered by AI

What are some of the primary indications for Bimatoprost SR?

"Bimatoprost SR can be used to lower intra ocular pressure in patients with open angle glaucoma, eyelash, and increased intra ocular pressure."

Answered by AI

Are there any more spots open for willing participants in this experiment?

"According to the latest information available on clinicaltrials.gov, this particular study is not presently recruiting patients for participation. Although the last update was on April 27th, 2022, this may change in the future. There are 976 other trials that are currently looking for participants."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Pacific Eye Associates
Houston Eye Associate
Arizona Glaucoma Specialists /ID# 240212
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

I'm afraid to loose my vision. i'm hopping this clinical trial will help me with my condition, i've tried 3 clinical trial and it didnt work.
PatientReceived 1 prior treatment
I had a central retinal vein occlusion in 2012. Since then, my IOP has increased little by little. In 2021 I was officially diagnosed with glaucoma in both eyes. I've been using Combigan and Lumigan to manage the pressure. In November 2022, I presented with an IOP in the 40s in both eyes. At that point, Dorzolamide was added to my routine. Two weeks later, my right eye had decreased into the 20s but my left eye was still in the 40s, so I was also given Rhopressa for the left eye. I am due to go back in for another pressure check on 1/20/23. However, I am expecting the doctor to discuss a Xen Stent procedure for the left eye and am looking for potential trials for me to partake in.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

When will the trial start? I am in the Houston area, are you doing this trial in Houston?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Long-term Safety and Efficacy Extension Trial of Bimatoprost SR
2019. "Long-term Safety and Efficacy Extension Trial of Bimatoprost SR". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03891446.
All > Glaucoma > Latisse
~184 spots leftby Aug 2026
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