Treatment OutcomePhase 1NCT06629129
Effect of Latanoprost on Optic Nerve Perfusion
A Phase 1 study testing Latanoprost (0.005%) in people with Treatment Outcome, run by Zagazig University at 1 site in Egypt.
Trial summary
46 eyes of 23 patients have been treated with topical Latanoprost 0.005 %. visual field was performed on all eyes. NFLT was measured using OCT. Radial peripapillary capillary (RPC) vascular density was measured using OCTA . Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Treatment Outcome
- What is being tested?
- Latanoprost (0.005%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jun 2024to 30 Aug 2024
- Phase
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- POAG with no past ocular surgery or laser retinal treatment. No previous anti-glaucoma medications
Who cannot join
- optic nerve lesions other than glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optic Nerve Head Perfusion Following Treatment with Latanoprost 0.005% in Primary Open Angle Glaucoma: an Optical Coherence Tomography Angiography Study
46 eyes of 23 patients have been treated with topical Latanoprost 0.005 %. visual field was performed on all eyes. NFLT was measured using OCT. Radial peripapillary capillary (RPC) vascular density was measured using OCTA . mean ocular perfusion pressure (MOPP), and RPC vascular density were measured before and after treatment BY 2-3 MONTHS
Read the detailed description
All patients had bilateral primary open angle glaucoma diagnosed by increased IOP, visual field changes, and defective nerve fiber layer thickness (NFLT) on OCT examination.
All patients treated with topical Latanoprost 0.005% (XalatanTM, 2.5 ml eye drops, Pfizer) Inclusion criteria: age \> 20 years, newly diagnosed patients with POAG. The exclusion criteria included optic nerve lesions other than glaucomatous changes, All patients completed their ophthalmic examination to detect BCVA, cycloplegic refraction, and anterior segment examination , IOP measuring by applanation tonometer, and indirect ophthalmoscope fundus examination.
Visual field testing. The thickness of NFL around the disc was evaluated using spectral domain optical coherence tomography (OCT) Optovue octa was used to quantify the density of the radial peripapillary capillary (RPC) vessels. This study employed software to quantify the capillary (microvasculature) density in both the entire image and in the peripapillary region specifically the superior, nasal, inferior, and temporal quadrants.
The mean arterial blood pressure (MAP) was determined by adding the diastolic blood pressure (DBP) to one third of the difference between systolic blood pressure and the diastolic blood pressure.
All eyes were treated with topical latanoprost 0.005% (XalatanTM, 2.5 ml eye drops, Pfizer) with dose of one drop at bedtime. IOP, MOPP, NFLT, and RPC vascular density were measured before the beginning of treatment and 1 and 3 months after treatment.
- Conditions
- Treatment Outcome
- Being tested
- Latanoprost (0.005%)
- Keywords
- Open angle glaucoma, OCTA, RNFL
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latanoprost (0.005%)Drug
MEAN OCULAR PERFUSION PRESSURE WAS MEASURED AND CORRELATED TO THE IOP AND OPTIC NERVE PERFUSION IN RESPONSE TO LATANOPROST TREATMENT
| Study group | Role | What they receive |
|---|---|---|
| EFFECT OF ANTI GLAUCOMA LATANOPROST 0.005 ON OPTIC NERVE PERFUSION | Other | EFFECT OF ANTI GLAUCOMA PROSTAGLANDIN 0.005 ON OPTIC NERVE PERFUSION Receives: Drug: Latanoprost (0.005%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantify the peri papillary capillary (microvasculature) density using OCTA
quantify the capillary (microvasculature) density in both the entire image and in the peripapillary region specifically the superior, nasal, inferior, and temporal quadrants
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 posted8 Oct 2024
- Study start24 Jun 2024
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Treatment OutcomeStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629129
- Sponsor's protocol ID
- #454/25-June-2024
- Status last verified
- Sep 2024
- First submitted
- 28 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harris A, Migliardi R, Rechtman E, Cole CN, Yee AB, Garzozi HJ. Comparative analysis of the effects of dorzolamide and latanoprost on ocular hemodynamics in normal tension glaucoma patients. Eur J Ophthalmol. 2003 Jan-Feb;13(1):24-31. doi: 10.1177/112067210301300104.
PubMed 12635671Gherghel D, Hosking SL, Cunliffe IA, Armstrong RA. First-line therapy with latanoprost 0.005% results in improved ocular circulation in newly diagnosed primary open-angle glaucoma patients: a prospective, 6-month, open-label study. Eye (Lond). 2008 Mar;22(3):363-9. doi: 10.1038/sj.eye.6702639. Epub 2006 Nov 17.
PubMed 17115020
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 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% in Primary Open Angle Glaucoma: an Optical Coherence Tomography Angiography Study
- ClinicalTrials.gov ID
- NCT06629129
- Acronym / sponsor ID
- #454/25-June-2024
- Conditions
- Treatment Outcome
- Keywords
- Open angle glaucoma, OCTA, RNFL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 8 Oct 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.
46 eyes of 23 patients have been treated with topical Latanoprost 0.005 %. visual field was performed on all eyes. NFLT was measured using OCT. Radial peripapillary capillary (RPC) vascular density was measured using OCTA . mean ocular perfusion pressure (MOPP), and RPC vascular density were measured before and after treatment BY 2-3 MONTHS
Detailed description
All patients had bilateral primary open angle glaucoma diagnosed by increased IOP, visual field changes, and defective nerve fiber layer thickness (NFLT) on OCT examination.
All patients treated with topical Latanoprost 0.005% (XalatanTM, 2.5 ml eye drops, Pfizer) Inclusion criteria: age \> 20 years, newly diagnosed patients with POAG. The exclusion criteria included optic nerve lesions other than glaucomatous changes, All patients completed their ophthalmic examination to detect BCVA, cycloplegic refraction, and anterior segment examination , IOP measuring by applanation tonometer, and indirect ophthalmoscope fundus examination.
Visual field testing. The thickness of NFL around the disc was evaluated using spectral domain optical coherence tomography (OCT) Optovue octa was used to quantify the density of the radial peripapillary capillary (RPC) vessels. This study employed software to quantify the capillary (microvasculature) density in both the entire image and in the peripapillary region specifically the superior, nasal, inferior, and temporal quadrants.
The mean arterial blood pressure (MAP) was determined by adding the diastolic blood pressure (DBP) to one third of the difference between systolic blood pressure and the diastolic blood pressure.
All eyes were treated with topical latanoprost 0.005% (XalatanTM, 2.5 ml eye drops, Pfizer) with dose of one drop at bedtime. IOP, MOPP, NFLT, and RPC vascular density were measured before the beginning of treatment and 1 and 3 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EFFECT OF ANTI GLAUCOMA LATANOPROST 0.005 ON OPTIC NERVE PERFUSION | Other | Drug: Latanoprost (0.005%)EFFECT OF ANTI GLAUCOMA PROSTAGLANDIN 0.005 ON OPTIC NERVE PERFUSION |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- POAG with no past ocular surgery or laser retinal treatment. No previous anti-glaucoma medications
Key exclusion criteria (1 listed)
- optic nerve lesions other than glaucoma
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 (0.005%)MEAN OCULAR PERFUSION PRESSURE WAS MEASURED AND CORRELATED TO THE IOP AND OPTIC NERVE PERFUSION IN RESPONSE TO LATANOPROST TREATMENT | Drug | EFFECT OF ANTI GLAUCOMA LATANOPROST 0.005 ON OPTIC NERVE PERFUSION |
Primary outcome
quantify the peri papillary capillary (microvasculature) density using OCTA
Time frame: 3 months
quantify the capillary (microvasculature) density in both the entire image and in the peripapillary region specifically the superior, nasal, inferior, and temporal quadrants
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 8 Oct 2024.
- Background: PubMed 12635671Harris A, Migliardi R, Rechtman E, Cole CN, Yee AB, Garzozi HJ. Comparative analysis of the effects of dorzolamide and latanoprost on ocular hemodynamics in normal tension glaucoma patients. Eur J Ophthalmol. 2003 Jan-Feb;13(1):24-31. doi: 10.1177/112067210301300104.
- Background: PubMed 17115020Gherghel D, Hosking SL, Cunliffe IA, Armstrong RA. First-line therapy with latanoprost 0.005% results in improved ocular circulation in newly diagnosed primary open-angle glaucoma patients: a prospective, 6-month, open-label study. Eye (Lond). 2008 Mar;22(3):363-9. doi: 10.1038/sj.eye.6702639. Epub 2006 Nov 17.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Latanoprost (0.005%) in people with Treatment Outcome, 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 8 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 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
quantify the peri papillary capillary (microvasculature) density using OCTA (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06629129, which also lists 2 linked publications.
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 8 Oct 2024.