brimonidine tartrate ophthalmic solution 0.025% for Glaucoma

Phase-Based Estimates
3
Effectiveness
3
Safety
Tulane University Medical Center, New Orleans, LA
Glaucoma+5 More
brimonidine tartrate ophthalmic solution 0.025% - Drug
Eligibility
18+
All Sexes
Eligible conditions
Glaucoma

Study Summary

This study is evaluating whether a medication used to treat eye redness may also help lower intraocular pressure in individuals with glaucoma.

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Eligible Conditions

  • Glaucoma
  • Glaucoma, Open-Angle
  • Glaucoma; Drugs
  • Droopy Eyelid
  • Ocular Hypertension, Primary Open-angle Glaucoma (POAG)
  • Ptosis

Treatment Effectiveness

Study Objectives

This trial is evaluating whether brimonidine tartrate ophthalmic solution 0.025% will improve 2 primary outcomes and 2 secondary outcomes in patients with Glaucoma. Measurement will happen over the course of 60 minutes after application of eye drop.

60 minutes after application of eye drop
Eye discomfort
Intraocular pressure
Ocular redness
Palpebral fissure height

Trial Safety

Trial Design

2 Treatment Groups

Control Arm
Lumify Arm
Placebo group

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Brimonidine Tartrate Ophthalmic Solution 0.025% is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Lumify Arm
Drug
In each subject, each eye will be randomized to receive a single drop of either Lumify™ (brimonidine tartrate ophthalmic solution 0.025%) or a sterile balanced saline solution.
Control Arm
Other
In each subject, each eye will be randomized to receive a single drop of either Lumify™ (brimonidine tartrate ophthalmic solution 0.025%) or a sterile balanced saline solution.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 60 minutes after application of eye drop
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 60 minutes after application of eye drop for reporting.

Closest Location

Tulane University Medical Center - New Orleans, LA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
is associated with lower ocular hypertension in African Americans African Americans who use brimonidine 0.2%, 0.15%, or 0.1% for current or greater than 6 weeks have lower ocular hypertension. show original
The person is over 18 years old. show original
The diagnosis of primary open angle glaucoma is made on the basis of characteristic optic nerve changes and progressive loss of peripheral vision show original
, an individual who participates in research must be competent A person who participates in research must be willing and able to give informed consent, and they must be competent. show original

Patient Q&A Section

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

How many people get glaucoma a year in the United States?

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Glaucoma may affect more than 20 million Americans, with over 300,000 new cases of glaucoma occurring each year. More than one third of these individuals are unaware they have the disease. Many who are aware that they have glaucoma have not seen a physician for years or years. Many of these patients will benefit from early referral. Results from a recent paper has defined the patient population most likely to benefit from an HVMS.

Unverified Answer

Can glaucoma be cured?

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Many patients with glaucoma are initially satisfied with the results of glaucoma surgery. They perceive improvement of symptomatology, vision, and amblyopia but are unwilling to continue with a careful long-term follow-up regimen. Further investigation is needed to develop a strategy that will maximize the long-term success rate.

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What are common treatments for glaucoma?

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Glaucoma patients often present with increased intraocular pressure, but few individuals will require medications to control their intraocular pressure. Frequently, glaucoma is managed with medication but surgical intervention may be appropriate in refractory patients.

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What is glaucoma?

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The prevalence and knowledge of glaucoma have an impact on the detection and referral pattern of glaucoma. Better knowledge and referral is the key factor for early treatment. The need for eye camps and a well equipped glaucoma department could be beneficial.

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What causes glaucoma?

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The same factors can cause acute angle closure glaucoma and ocular hypertension. Glaucoma develops as a result of the same mechanisms causing the problems of intraocular pressure. The damage to the optic nerve and the consequent loss of visual function is common to all types of glaucoma and all forms of ocular hypertension. It is also important to differentiate the different types of glaucoma as different treatments and patterns of progression may be required. It is the cause of blindness in nearly 10% of Africans.\n

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What are the signs of glaucoma?

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Many patients with glaucoma have no obvious symptoms. Many signs are subjective and vary greatly between patients. Some signs may change over time. An important sign of glaucoma is visual field loss.\n

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Who should consider clinical trials for glaucoma?

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There is low use of clinical trials in glaucoma. Those who have a high burden of disease for treatment are the most likely to use trials, and those who choose not to use trials as the primary source of information are unlikely to be satisfied or satisfied by the information available.

Unverified Answer

What is brimonidine tartrate ophthalmic solution 0.025%?

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Brimonidine ophthalmic solution 0.025% had an effect on intraocular pressure (IOP) and did affect iris hue. However, these results did not meet our study's primary objective.

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Have there been other clinical trials involving brimonidine tartrate ophthalmic solution 0.025%?

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More studies in the next few years are required to answer whether or not bstatolac has a useful role as a steroid-sparing agent in glaucoma. We expect more good evidence to emerge when the current pilot studies are completed.

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What is the average age someone gets glaucoma?

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Average age of diagnosis was not earlier in women than men but age was not significantly different. The age at onset of the pathology in patients who develop glaucoma correlates with age in the general population. There is no evidence of acceleration of onset of glaucoma as age increases

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What does brimonidine tartrate ophthalmic solution 0.025% usually treat?

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Brimonadin tartrate ophthalmic solution 0.025% treatment results in significant reduction of IOP compared with placebo, at 2, 4, and 8 weeks before intravitreal injection for phakic subjects with medically uncontrolled glaucoma or ocular hypertension. Brimonadin’s favourable safety profile and favourable ocular tolerability profile warrant further consideration in this patient population.

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Does brimonidine tartrate ophthalmic solution 0.025% improve quality of life for those with glaucoma?

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In comparison with the placebo treatment, brimonidine treatment resulted in better improvement in QoL in glaucoma patients in the short term. This suggests that brimonidine tartrate ophthalmic solution 0.025% has a positive effect on glaucoma patients.

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