ComBaT for Glaucoma

Recruiting at 1 trial location

Overseen By Jade Livingston

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Eye pain, Vision decrease, Double vision, Pregnancy, Prisoners, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to evaluate if intervention and education can change the behavior of someone's willingness to see an eye care provider to prevent blindness and glaucoma. The researchers are investigating if adding additional resources improves participant access to care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What safety data exists for ComBaT Glaucoma treatment?

The safety of glaucoma medications, including those potentially related to ComBaT Glaucoma, often involves side effects like dry eye and burning sensations, which can lead to stopping the treatment. Preservatives in these medications, such as benzalkonium chloride, are known to cause adverse effects, but preservative-free options may reduce these issues. ^{1 2 3 4 5}

How does the ComBaT treatment for glaucoma differ from other treatments?

The ComBaT treatment for glaucoma is unique because it may involve a combination of therapies that not only aim to lower intraocular pressure (IOP) but also focus on neuroprotection and immunomodulation, potentially using strategies like gene therapy, antioxidants, and cell transplantation to prevent retinal cell degeneration and improve patient outcomes. ^{6 7 8 9 10}

Research Team

Angela Elam

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is specifically for Black or African American individuals who have already taken part in the screening exam phase of the study. It aims to see if extra support and education can encourage them to regularly visit eye care professionals, potentially preventing blindness due to glaucoma.

Inclusion Criteria

This criterion excludes individuals who are Black or African American.

You have already taken part in the initial screening tests for the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive community-engaged and faith-based interventions to increase eye care utilization

6 months

Initial clinical evaluation within 6 months

Follow-up

Participants are monitored for eye care utilization and follow-up evaluations

8 months

Follow-up evaluation at 12 months

Treatment Details

Interventions

• ComBaT Glaucoma

Trial Overview The ComBaT Glaucoma intervention is being tested to determine whether providing additional resources and education can improve a person's likelihood of seeking regular eye care services, which could help prevent vision loss from glaucoma.

Participant Groups

Group I: Eye concern Experimental Treatment 1 Intervention

Those with a diagnosis of glaucoma or glaucoma suspect (or other concerning eye disease, such as diabetic retinopathy or macular degeneration) will be invited to participate in the ComBaT Glaucoma.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

The safety profile of glaucoma medications is crucial for treatment adherence, as side effects can lead to patients not following their prescribed therapy.

Long-term use of glaucoma eyedrops, especially those with preservatives, can cause ocular surface changes and systemic effects, highlighting the need for careful selection of medications and patient education on potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of glaucoma medications. Detry-Morel, M.[2018]

In a study involving 3,333 glaucoma patients, 79% reported satisfaction with their topical glaucoma medications, indicating a high level of acceptance among users.

The most commonly prescribed medications, including timolol and latanoprost, showed comparable tolerability, with only a 9% chance of patients needing to change their medication due to side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of commonly used glaucoma medications: comparison of tolerability, chance of discontinuation, and patient satisfaction. Beckers, HJ., Schouten, JS., Webers, CA., et al.[2021]

Antiglaucoma medications containing benzalkonium chloride (BAK) are linked to adverse ocular reactions like dry eye and burning sensations, which can lead to treatment discontinuation and decreased quality of life for patients.

Clinical studies indicate that switching to preservative-free antiglaucoma treatments can significantly reduce these adverse effects, suggesting important benefits for patient comfort and adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detrimental effect of preservatives in eyedrops: implications for the treatment of glaucoma. Baudouin, C.[2008]

In a study of 165 patients with glaucoma, 38 experienced adverse effects related to the addition of timolol to their treatment regimen.

Timolol had to be discontinued in 15 patients (9%) due to these side effects, indicating a need for further double-masked studies to better understand the safety profile of timolol in glaucoma therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects experienced by patients taking timolol. McMahon, CD., Shaffer, RN., Hoskins, HD., et al.[2019]

In a survey of 243 glaucoma patients in southern India, 42% reported experiencing problems with their glaucoma medications, which may impact their treatment effectiveness.

The study found that nonadherence to medication was notably higher among unmarried patients and those who had difficulty with the medication bottle, highlighting the need for better support and education for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported barriers to glaucoma medication access, use, and adherence in southern India. Sleath, BL., Krishnadas, R., Cho, M., et al.[2022]

Glaucoma affects approximately 60 million people worldwide, with many cases undiagnosed, highlighting the need for better detection methods since vision loss is irreversible.

Current treatments, primarily daily eye drops, face adherence challenges due to the asymptomatic nature of the disease, but future gene therapy approaches may offer new treatment possibilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glaucoma. Quigley, HA.[2022]

New therapeutic approaches for glaucoma are emerging beyond traditional intraocular pressure reduction, including the use of magnesium, gingko, and fludrocortisone, which can help manage blood pressure and improve vascular regulation.

Experimental strategies show promise in preventing glaucomatous optic neuropathy through various mechanisms, such as inhibiting astrocyte activation and oxidative stress, with potential protective agents including dark chocolate, polyphenolic flavonoids, and melatonin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there more to glaucoma treatment than lowering IOP? Mozaffarieh, M., Flammer, J.[2007]

Future glaucoma treatments aim to not only lower intraocular pressure but also to protect retinal cells from degeneration by targeting various intracellular mechanisms and immunological responses.

Current promising strategies include the use of citicoline to reduce glutamate toxicity, Rho kinase inhibitors for promoting nerve regeneration, and neurotrophic factors to prevent cell damage, alongside emerging immunomodulatory therapies and antioxidants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New perspectives of immunomodulation and neuroprotection in glaucoma. Skopiński, P., Radomska-Leśniewska, DM., Izdebska, J., et al.[2021]

The traditional focus on lowering intraocular pressure (IOP) as the primary goal in glaucoma management is being challenged, with a call for treatment success to be measured by outcomes beyond IOP.

Current clinical trials in glaucoma are emphasizing patient well-being rather than just IOP reduction, indicating a shift towards evaluating the effectiveness of treatments in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating research into practice: controlled clinical trials and their influence on glaucoma management. Wilson, MR., Gaasterland, D.[2007]

Recent advancements in glaucoma treatment include new topical medications that target the trabecular meshwork and conventional outflow pathways, such as rho kinase inhibitors and nitric oxide donating compounds, which have received FDA approval and aim to reduce intraocular pressure more effectively.

Innovative therapies like gene therapy and stem cell strategies are being developed to provide long-term pressure control without the need for daily eye drops, potentially easing the treatment burden for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glaucoma Drugs in the Pipeline. Kaufman, PL., Mohr, ME., Riccomini, SP., et al.[2018]

References

1. Belgium pubmed.ncbi.nlm.nih.gov

Side effects of glaucoma medications. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Side effects of commonly used glaucoma medications: comparison of tolerability, chance of discontinuation, and patient satisfaction. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Detrimental effect of preservatives in eyedrops: implications for the treatment of glaucoma. [2008]

4. United States pubmed.ncbi.nlm.nih.gov

Adverse effects experienced by patients taking timolol. [2019]

5. India pubmed.ncbi.nlm.nih.gov

Patient-reported barriers to glaucoma medication access, use, and adherence in southern India. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Glaucoma. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Is there more to glaucoma treatment than lowering IOP? [2007]

8. Poland pubmed.ncbi.nlm.nih.gov

New perspectives of immunomodulation and neuroprotection in glaucoma. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Translating research into practice: controlled clinical trials and their influence on glaucoma management. [2007]

10. China pubmed.ncbi.nlm.nih.gov

Glaucoma Drugs in the Pipeline. [2018]