Optic Nerve Perfusion Following Treatment with Latanoprost Versus Brimionidin Tartrate

NCT06730516 | Completed Early Phase 1

• 2 other identifiers: #454/25-June-2024.Zagazig University
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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 patients in each group

Conditions

Glaucoma

Keywords

Latanoprost; Brimonidine

Outcome Measures

Primary Outcomes (1)

• 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).

  3 months

Study Arms (2)

Latanoprost (Xalatan)

EXPERIMENTAL

Group (1) included 23 patients (46 eyes) treated with Latanoprost 0.005 %

Drug: Latanoprost (Xalatan)

Brimonidine 0.2%

EXPERIMENTAL

24 patients (48 eyes) received treatment with Brimonidin tartrate 0.2% in group (2)

Drug: Brimonidine 0.2 %

Interventions

Latanoprost (Xalatan) DRUG

latanoprost 0.005

Latanoprost (Xalatan)

Brimonidine 0.2 % DRUG

Brimonidine0.2

Brimonidine 0.2%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age more than 18 years newly diagnosed naive patients with POAG

You may not qualify if:

• optic nerve lesions other than glaucomatous changes patients with previous glaucoma surgery

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University

Zagazig, Sharqia Province, 44511, Egypt

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Yasmine A Deiaeldin, MD

  Zagazig University

  STUDY DIRECTOR

• Hani elbialy, MD

  Zagazig University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 12, 2024
• Study Start: June 24, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)