GlaucomaEarly Phase 1NCT06730516
Optic Nerve Perfusion Following Treatment with Latanoprost Versus Brimionidin Tartrate
A Early Phase 1 study testing Latanoprost (Xalatan) and Brimonidine 0.2 % in people with Glaucoma, run by Zagazig University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the effects of topical Latanoprost 0.005 % versus Brimionidin tartrate 0.2% on perfusion of optic nerve head This prospective interventional randomized study included 56 naive patients recently diagnosed with bilateral primary open angle glaucoma equally divided into two groups with 28… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Latanoprost (Xalatan) and Brimonidine 0.2 %
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jun 2024to 1 Oct 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age more than 18 years newly diagnosed naive patients with POAG
Who cannot join
- optic nerve lesions other than glaucomatous changes patients with previous glaucoma surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optic Nerve Head Perfusion Following Treatment with Latanoprost 0.005% Versus Brimionidin Tartrate 0.2% in Primary Open Angle Glaucoma: an Optical Coherence Tomography Angiography Study
This study aimed to evaluate the effects of topical Latanoprost 0.005 % versus Brimionidin tartrate 0.2% on perfusion of optic nerve head This prospective interventional randomized study included 56 naive patients recently diagnosed with bilateral primary open angle glaucoma equally divided into two groups with 28 patients in each group
Read the detailed description
This study aimed to evaluate the effects of topical Latanoprost 0.005 % versus Brimionidin tartrate 0.2% on perfusion of optic nerve head This prospective interventional randomized study included 56 naive patients recently diagnosed with bilateral POAG equally divided into two groups with 28 patients in each group. The whole VD was increased and also increased in all four nasal, temporal, superior, and inferior quadrants around optic disc from the initial vessel density before treatment (p<0.001) in both groups significantly with superior improvement in group (1) compared to group (2) that was statistically significant
- Conditions
- Glaucoma
- Being tested
- Latanoprost (Xalatan), Brimonidine 0.2 %
- Keywords
- Latanoprost, Brimonidine
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latanoprost (Xalatan)Drug
latanoprost 0.005
Brimonidine 0.2 %Drug
Brimonidine0.2
| Study group | Role | What they receive |
|---|---|---|
| Latanoprost (Xalatan) | Experimental | Group (1) included 23 patients (46 eyes) treated with Latanoprost 0.005 % Receives: Drug: Latanoprost (Xalatan) |
| Brimonidine 0.2% | Experimental | 24 patients (48 eyes) received treatment with Brimonidin tartrate 0.2% in group (2) Receives: Drug: Brimonidine 0.2 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
OPTIC NERVE PERFUSION using OCT angiography numerical analysis system presented in %
perfusion of optic nerve head in patients with primary open angle glaucoma (POAG) using optical coherence tomography angiography (OCTA).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start24 Jun 2024
- Primary completion1 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective interventional randomized study included 56 naive patients recently diagnosed with bilateral primary open angle glaucoma equally divided into two groups with 28 patients in each group. Nine patients, five in group (1) and four in group (2) were excluded due to poor quality OCTA images or non-compliance). Group (1) included 23 patients (46 eyes) treated with Latanoprost 0.005 % while 24 patients (48 eyes) received treatment with Brimonidin tartrate 0.2% in group (2).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yasmine A Deiaeldin, MD, Study director, Zagazig UniversityHani elbialy, MD, Study director, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730516
- Sponsor's protocol ID
- #454/25-June-2024.
- Other IDs
- Zagazig University
- Status last verified
- Jun 2024
- First submitted
- 6 Dec 2024
- Last updated
- 12 Dec 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optic Nerve Head Perfusion Following Treatment with Latanoprost 0.005% Versus Brimionidin Tartrate 0.2% in Primary Open Angle Glaucoma: an Optical Coherence Tomography Angiography Study
- ClinicalTrials.gov ID
- NCT06730516
- Acronym / sponsor ID
- #454/25-June-2024.
- Conditions
- Glaucoma
- Keywords
- Latanoprost, Brimonidine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 12 Dec 2024 (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.
This study aimed to evaluate the effects of topical Latanoprost 0.005 % versus Brimionidin tartrate 0.2% on perfusion of optic nerve head This prospective interventional randomized study included 56 naive patients recently diagnosed with bilateral primary open angle glaucoma equally divided into two groups with 28 patients in each group
Detailed description
This study aimed to evaluate the effects of topical Latanoprost 0.005 % versus Brimionidin tartrate 0.2% on perfusion of optic nerve head This prospective interventional randomized study included 56 naive patients recently diagnosed with bilateral POAG equally divided into two groups with 28 patients in each group. The whole VD was increased and also increased in all four nasal, temporal, superior, and inferior quadrants around optic disc from the initial vessel density before treatment (p<0.001) in both groups significantly with superior improvement in group (1) compared to group (2) that was statistically significant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This prospective interventional randomized study included 56 naive patients recently diagnosed with bilateral primary open angle glaucoma equally divided into two groups with 28 patients in each group. Nine patients, five in group (1) and four in group (2) were excluded due to poor quality OCTA images or non-compliance). Group (1) included 23 patients (46 eyes) treated with Latanoprost 0.005 % while 24 patients (48 eyes) received treatment with Brimonidin tartrate 0.2% in group (2).
| Arm | Type | Receives |
|---|---|---|
| Latanoprost (Xalatan) | Experimental | Drug: Latanoprost (Xalatan)Group (1) included 23 patients (46 eyes) treated with Latanoprost 0.005 % |
| Brimonidine 0.2% | Experimental | Drug: Brimonidine 0.2 %24 patients (48 eyes) received treatment with Brimonidin tartrate 0.2% in group (2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age more than 18 years newly diagnosed naive patients with POAG
Key exclusion criteria (1 listed)
- optic nerve lesions other than glaucomatous changes patients with previous glaucoma surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Latanoprost (Xalatan)latanoprost 0.005 | Drug | Latanoprost (Xalatan) |
| Brimonidine 0.2 %Brimonidine0.2 | Drug | Brimonidine 0.2% |
Primary outcome
OPTIC NERVE PERFUSION using OCT angiography numerical analysis system presented in %
Time frame: 3 months
perfusion of optic nerve head in patients with primary open angle glaucoma (POAG) using optical coherence tomography angiography (OCTA).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
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. This study is not recruiting at the moment.
Yasmine A Deiaeldin, MD study director
Zagazig University
Hani elbialy, MD study director
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Latanoprost (Xalatan) and Brimonidine 0.2 % in people with Glaucoma, run by Zagazig University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Dec 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 Egypt. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OPTIC NERVE PERFUSION using OCT angiography numerical analysis system presented in % (time frame: 3 months). 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 12 Dec 2024.