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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

Must not have

Female participants who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study.

For patients from the ARGOS lead-in study: history of prior incisional glaucoma surgeries and/or minimally invasive glaucoma surgical procedures in the study eye or treated fellow eye.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 24 months

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I completed a Phase 3 study for Bimatoprost SR and received the treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, nursing, planning to become pregnant, or if capable of becoming pregnant, I am using reliable contraception.

Select...

I have had glaucoma surgery in either eye.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Dry eye

Hypertension

Punctate keratitis

Nasopharyngitis

Intraocular pressure increased

Lacrimation increased

Vision blurred

Anterior chamber cell

Corneal oedema

Influenza

Headache

Visual field defect

Umbilical hernia

Haemorrhoids

Acute myocardial infarction

Myocardial infarction

Chest pain

Clostridium difficile infection

Femur fracture

Road traffic accident

Intraductal proliferative breast lesion

Cerebrovascular accident

Trigeminal neuralgia

Pulmonary embolism

Hiatus hernia

Lumbar spinal stenosis

Embolic stroke

Varicose vein

Acute coronary syndrome

Gastric ulcer

Intestinal obstruction

Iridocyclitis

Cardiac arrest

Small intestinal obstruction

Cerebral haemorrhage

Chondrocalcinosis pyrophosphate

Renal failure

Internal haemorrhage

100%

80%

60%

40%

20%

Study treatment Arm

Bimatoprost SR 15 μg

Timolol 0.5%: Comparator

Bimatoprost SR 10 μg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 3Eligibility criteria met