Glaucoma, Open-AngleNCT05039684
Inflammatory Biomarkers in Ocular Surface in Primary Open Angle Glaucoma or Ocular Hypertension Under Topical Prostaglandins
An observational study of Glaucoma, Open-Angle and Ocular Hypertension, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 1 site in Spain.
Trial summary
Glaucoma is a chronic optic neuropathy whose main modifiable risk factor is an abnormally elevated intraocular pressure. The aim of glaucoma treatment is to slow the progression of the disease by reducing intraocular pressure. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2021to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with ocular hypertension or primary open angle glaucoma
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
IOBA
Valladolid, 47011
Carolina Ossa Calderon, MD, MsC, 983184734, cossac@ioba.med.uva.es
Francisco Blazquez Arauzo, MD, MsC, 983184734, blazquez@ioba.med.uva.es
About this study
Official title: Inflammatory Biomarkers in Ocular Surface in Patients With Primary Open Angle Glaucoma and Ocular Hypertension Under Topical Prostaglandin Therapy
Glaucoma is a chronic optic neuropathy whose main modifiable risk factor is an abnormally elevated intraocular pressure. The aim of glaucoma treatment is to slow the progression of the disease by reducing intraocular pressure.
Prostaglandin derivatives are the most effective topical drugs in reducing intraocular pressure (IOP). Among these, latanoprost was the first agent of this type to be approved for use in patients with glaucoma or ocular hypertension.
Read more
These eye drops are available with and without preservatives. There are two commercial brands in our environment, Xalatan®, which contains 0.005% latanoprost and 0.2 mg/ml benzalkonium chloride (BAK) and Monoprost®, which contains the same amount of latanoprost but does not carry a preservative. The prostaglandin analog with a lower concentration of active ingredient available in Spain without preservative is tafluprost 0.0015%, commercially available under the name Saflutan®.
The long-term use of hypotensive eye drops with preservatives generates changes in the ocular surface, such as instability of the tear film, conjunctival inflammation, subconjunctival fibrosis, apoptosis of the conjunctival epithelium and deterioration of the corneal surface, causing symptoms such as stinging, tearing, sensation foreign body, photophobia and blurred vision.
This research will evaluate the changes in the ocular surface and in the expression of inflammatory molecules that occur in the conjunctiva in patients with a diagnosis of glaucoma and ocular hypertension who are under ocular hypotensive treatment with tafluprost, comparing it with the two commercial preparations of latanoprost.
These three groups of patients will have a control group of patients with a diagnosis of ocular hypertension who will not have any topical hypotensive medication.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Keywords
- glaucoma, prostaglandin, ocular hypertension, biomarker, inflammation, confocal in-vivo microscopy, cornea, tear film, conjunctiva, impression cytology
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma, Inflammation, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary open angle glaucoma / ocular hypertension - Treatment with Xalatan | Patients with primary open angle glaucoma or ocular hypertension treated with Xalatan | |
| Primary open angle glaucoma / ocular hypertension - Treatment with Monoprost | Patients with primary open angle glaucoma or ocular hypertension treated with Monoprost | |
| Primary open angle glaucoma / ocular hypertension - Treatment with Saflutan | Patients with primary open angle glaucoma or ocular hypertension treated with Saflutan | |
| Ocular hypertension - No treatment | Patients ocular hypertension untreated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory response in ocular surface secondary to prostaglandin use
Presence of inflammatory cytokines in ocular surface
Measured: 24 hours
Conjunctival cell phenotype and inflammatory infiltration
Conjunctival cell phenotype assessment by conjunctival in vivo confocal microscopy
Measured: 24 hours
Changes in oxidative stress in the tear film
Changes in oxidative stress at conjunctiva secondary to prostaglandin treatment
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Oct 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valladolid
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039684
- Sponsor's protocol ID
- IOBA-2021-44
- Status last verified
- Oct 2024
- First submitted
- 27 Aug 2021
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Biomarkers in Ocular Surface in Patients With Primary Open Angle Glaucoma and Ocular Hypertension Under Topical Prostaglandin Therapy
- ClinicalTrials.gov ID
- NCT05039684
- Acronym / sponsor ID
- IOBA-2021-44
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Keywords
- glaucoma, prostaglandin, ocular hypertension, biomarker, inflammation, confocal in-vivo microscopy, cornea, tear film
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBAUniversity, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valladolid
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Glaucoma is a chronic optic neuropathy whose main modifiable risk factor is an abnormally elevated intraocular pressure. The aim of glaucoma treatment is to slow the progression of the disease by reducing intraocular pressure.
Prostaglandin derivatives are the most effective topical drugs in reducing intraocular pressure (IOP). Among these, latanoprost was the first agent of this type to be approved for use in patients with glaucoma or ocular hypertension.
These eye drops are available with and without preservatives. There are two commercial brands in our environment, Xalatan®, which contains 0.005% latanoprost and 0.2 mg/ml benzalkonium chloride (BAK) and Monoprost®, which contains the same amount of latanoprost but does not carry a preservative. The prostaglandin analog with a lower concentration of active ingredient available in Spain without preservative is tafluprost 0.0015%, commercially available under the name Saflutan®.
The long-term use of hypotensive eye drops with preservatives generates changes in the ocular surface, such as instability of the tear film, conjunctival inflammation, subconjunctival fibrosis, apoptosis of the conjunctival epithelium and deterioration of the corneal surface, causing symptoms such as stinging, tearing, sensation foreign body, photophobia and blurred vision.
This research will evaluate the changes in the ocular surface and in the expression of inflammatory molecules that occur in the conjunctiva in patients with a diagnosis of glaucoma and ocular hypertension who are under ocular hypotensive treatment with tafluprost, comparing it with the two commercial preparations of latanoprost.
These three groups of patients will have a control group of patients with a diagnosis of ocular hypertension who will not have any topical hypotensive medication.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Primary open angle glaucoma / ocular hypertension - Treatment with Xalatan | – | –Patients with primary open angle glaucoma or ocular hypertension treated with Xalatan |
| Primary open angle glaucoma / ocular hypertension - Treatment with Monoprost | – | –Patients with primary open angle glaucoma or ocular hypertension treated with Monoprost |
| Primary open angle glaucoma / ocular hypertension - Treatment with Saflutan | – | –Patients with primary open angle glaucoma or ocular hypertension treated with Saflutan |
| Ocular hypertension - No treatment | – | –Patients ocular hypertension untreated |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with ocular hypertension or primary open angle glaucoma
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inflammatory response in ocular surface secondary to prostaglandin use
Time frame: 24 hours
Presence of inflammatory cytokines in ocular surface
Conjunctival cell phenotype and inflammatory infiltration
Time frame: 24 hours
Conjunctival cell phenotype assessment by conjunctival in vivo confocal microscopy
Changes in oxidative stress in the tear film
Time frame: 24 hours
Changes in oxidative stress at conjunctiva secondary to prostaglandin treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, Open-Angle and Ocular Hypertension, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolina Ossa Calderon, MD (983184734, cossac@ioba.med.uva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory response in ocular surface secondary to prostaglandin use (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024; AzTrials last refreshed its copy on 26 Oct 2026.