Investigating inflammatory biomarkers in glaucoma patients using prostaglandin eye drops
Inflammatory Biomarkers in Ocular Surface in Patients With Primary Open Angle Glaucoma and Ocular Hypertension Under Topical Prostaglandin Therapy
This study is testing how eye drops used for glaucoma affect inflammation in the eyes of people who have been using them for at least three months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA Academic / other |
| Locations | 1 site (Valladolid) |
| Trial ID | NCT05039684 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the role of inflammatory biomarkers in the ocular surface of patients with primary open-angle glaucoma or ocular hypertension who are being treated with topical prostaglandins. Participants must have been on monotherapy with specific prostaglandin medications for at least three months. The study will assess the impact of these treatments on ocular inflammation and the overall health of the eye. The findings could provide insights into the relationship between inflammation and glaucoma management.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with primary open-angle glaucoma or ocular hypertension who have been on specific prostaglandin therapy for at least three months.
Not a fit: Patients with recent ocular surgery or other active ocular surface diseases unrelated to glaucoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of ocular inflammation in glaucoma, potentially leading to improved treatment strategies.
How similar studies have performed: While the specific approach of this study may be novel, there is existing research on the effects of prostaglandins in glaucoma treatment, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with primary open angle glaucoma or ocular hypertension as defined in Early Manifest Glaucoma Trial * \> 18 years old * Signed informed consent * 3 or more months under monotherapy treatment with tafluprost 0.0015%, latanoprost 0.005% with BAK 0.2mg/ml or latanoprost 0.005%. * Untreated patients with ocular hypertension must be treatment naïve for the pathology. * No presence or history of previous ocular diseases other than glaucoma or ocular hypertension, started before the use of hypotensive medication. Exclusion Criteria: * Ocular surgery in the previous 6 months. * Any ocular surface disease not related to inclusion criteria or related issues active within the last 6 months. * Any topical treatment other than the evaluated in this study in the last 3 months. * In case of artificial teardrops use, only non conservative ones are allowed, with no more than 4 times per day use, and treatment must be suspended 5 days before inclusion. * Use of contact lenses in the las 4 weeks. * Any mental or physical disease that may prevent performing the required tests for the study.
Where this trial is running
Valladolid
- Ioba — Valladolid, Spain (Recruiting)
Study contacts
- Study coordinator: Carolina Ossa Calderon, MD
- Email: cossac@ioba.med.uva.es
- Phone: 983184734
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.