Bimatoprost (SR) for Glaucoma, Suspect

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Fondazione IRCCS Policlinico /ID# 236909, Pavia, Italy
Glaucoma, Suspect+4 More
Bimatoprost (SR) - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a medication which reduces pressure in the eye may help treat glaucoma.

See full description

Eligible Conditions

  • Glaucoma, Suspect
  • Open Angle Glaucoma (OAG)

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Bimatoprost (SR) will improve 2 primary outcomes in patients with Glaucoma, Suspect. Measurement will happen over the course of Baseline up to 48 months.

Month 48
Number of patients experiencing a treatment emergent adverse event
Up to 48 months
Retreatment or rescue administered for IOP

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Bimatoprost SR - Dose B
1 of 2
Bimatoprost SR - Dose A
1 of 2
Experimental Treatment

This trial requires 490 total participants across 2 different treatment groups

This trial involves 2 different treatments. Bimatoprost (SR) is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Bimatoprost SR - Dose B
Drug
Study Eye: Participants received 1-3 Cycles of Bimatoprost SR administrations of Dose B Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.
Bimatoprost SR - Dose A
Drug
Study Eye: Participants will receive 1 - 3 Cycles of Bimatoprost SR administrations of Dose A Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 48 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 48 months for reporting.

Closest Location

Vantage EyeCare LLC /ID# 235741 - Bala-Cynwyd, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
- Diagnosis of either Diagnosis of either open angle glaucoma (OAG) (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or ocular hypertension requiring intraocular pressure-lowering treatment.

Patient Q&A Section

What is glaucoma, open-angle?

"Glaucoma is a disease that causes visual impairment, primarily due to retinal damage. One of the main causes is an increased pressure in the eye. It can be controlled with the use of proper treatment and/or lifestyle changes. People can decrease their risk of developing glaucoma by keeping an eye on diet and exercising at regular intervals.\n" - Anonymous Online Contributor

Unverified Answer

How many people get glaucoma, open-angle a year in the United States?

"About 1.3 million individuals in the United States are estimated to be affected by glaucoma or ocular hypertension. question: Is the incidence of [cataract](https://www.withpower.com/clinical-trials/cataract) rising as the population ages in the United States : a study of Medicare beneficiaries ages 65 to 94 years in 1990? answer: The projected increased incidence of cataracts in the U.S. is expected to be evident in the next five to ten years. The incidence rate of cataract surgery over the age of 65 years is anticipated to increase by 20% per year. This phenomenon should be considered in the delivery of preventive health services to the growing population of older Americans." - Anonymous Online Contributor

Unverified Answer

What causes glaucoma, open-angle?

"Glaucoma, open-angle, is not a single disease, but resembles many conditions where it causes damage to the optic nerve. The most important risk factors for open-angle glaucoma, open-angle glaucoma, are age and primary open-angle angle closure. Secondary open-angle glaucoma occurs following the development of ocular hypertension, often in response to the presence of a risk, such as angle closure or angle dystocia; glaucoma can also be due to the breakdown of the trabecular meshwork and the loss of the vascular network within the eye." - Anonymous Online Contributor

Unverified Answer

What are the signs of glaucoma, open-angle?

"Glaucoma is the most common ocular disease and is usually detected due to symptoms, with signs in the form of blurry vision, decreased visual acuity, and optic disc haemorrhage being common. Patients with glaucoma often have an insidious onset of vision loss, and they can be asymptomatic for years before diagnosis. Clinical characteristics of glaucoma include an increased intraocular pressure, an abnormal optic disc, an abnormal vertical cup to disc ratio, a thin nerve fibre layer, and small retinal venules. Glaucoma can often be asymptomatic for years before symptoms become apparent." - Anonymous Online Contributor

Unverified Answer

Can glaucoma, open-angle be cured?

"The data suggest that there is no cure for glaucoma, open-angle and that the only benefit is one time surgery. It can happen; as a last resort, where there is evidence of uncontrolled worsening and a visual field loss, or when the medical management is obviously inadequate (e.g. unresponsive optic neuropathy, severe pain, high IOP or angle closure/scarred iris) or is there a risk to the visual function of the eye (e.g. angle closure glaucoma, uveofibrosis, retinal detachment or cataract)." - Anonymous Online Contributor

Unverified Answer

What are common treatments for glaucoma, open-angle?

"When glaucoma starts in childhood or adolescence, glaucoma medications do not appear to change the risk of subsequent cataract, further glaucoma, or a retinal detachment. When glaucoma starts in adulthood, glaucoma medications appear to change the risk of future cataract." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of bimatoprost (sr)?

"A higher dose of 0.003 % bimatoprost in an ocular solution may cause blurred vision. Moreover, the most common adverse effect of bimatoprost was ocular pain. As bimatoprost has been used at lower concentrations since it was approved in the US, it deserves further consideration." - Anonymous Online Contributor

Unverified Answer

Has bimatoprost (sr) proven to be more effective than a placebo?

"The efficacy and safety profile of 0.025 mg Bimatoprost in controlling ocular hypertension is consistent with the FDA label and the AURORA study of Bimatoprost 0.01--0.03 mg vs preservative-free aqueous diclofenac and Bimatoprost 0.0001--0.003 mg vs preservative-free timolol (0.01--0.03 mg) in patients with advanced open angle glaucoma. Recent findings suggest that 0.025 mg Bimatoprost is a clinically appropriate dose for the treatment of ocular hypertension associated with open-angle glaucoma." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving bimatoprost (sr)?

"There are no prospective, controlled studies on bimatoprost available in the literature, and the results of these studies have thus far come only from a small number of individual patients. Moreover, the efficacy and side effects are limited data for this substance. Therefore, further evaluations in this area should be conducted." - Anonymous Online Contributor

Unverified Answer

Is bimatoprost (sr) safe for people?

"While the most common side effects were eye inflammation (6,000%) and blurry vision (4,900%), 1.2% of persons discontinuing bimatoprost discontinued due to these side effects. One percent of persons discontinued use of bimatoprost because they were dissatisfied, with less than 1% not achieving improvements in IOP. For most, the improvement in IOP was statistically significant." - Anonymous Online Contributor

Unverified Answer

What does bimatoprost (sr) usually treat?

"The most common clinical indications listed were glaucoma with or without open angle, open angle glaucoma and ocular hypertension. Treatment with bimatoprost (sr) is used most efficiently by glaucoma specialists for patients who have poor VA or who have poor ocular hypertension control with a combination of other ocular hypotensive drugs. The drug is particularly helpful in patients who have open-angle glaucoma. In order to qualify for bimatoprost (sr) treatment, patients must have open angle glaucoma with uncontrolled intraocular pressure and/or VA with a minimum PVR20." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for glaucoma, open-angle?

"Clinical trials should be offered to patients who have had glaucoma for many years, are candidates for procedures that were not successful, if they have progressive vision loss, and should be offered after a detailed history." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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