Bromfenac Sodium Hydrate Eye Drops in Familial Exudative Vitreoretinopathy

November 20, 2023 updated by: Jeong Hun Kim, Seoul National University Hospital

Efficacy of Bromfenac Sodium Hydrate Eye Drops in Children With Familial Exudative Vitreoretinopathy After Diode Laser Photocoagulation

This study aims to investigate the efficacy and safety of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to evaluate the presence of macular edema as the primary measure and the presence of conjunctival injection as the secondary measure for the investigation of the efficacy of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • IRB Support team Center
          • Phone Number: 82-2-2072-2613
          • Email: irb@snuh.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 7 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Newly diagnosed patients with familial exudative vitreoretinopathy
  • Needing diode laser photocoagulation
  • Consent to the study

Exclusion Criteria:

  • History of corneal diseases
  • History of hypersensitivity to bromfenac sodium
  • History of hypersensitivity to non-steroidal anti-inflammatory drugs
  • Progressive ocular infection
  • Liver diseases
  • Hypersensitivity to sulfur dioxide
  • Receiving anti-coagulation drugs
  • History of coagulopathies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bromfenac sodium hydrate eye drops
The patients will receive bromfenac sodium hydrate eye drops twice daily for 14 days.
Drug: Bromfenac Sodium
The study participants will receive bromfenac sodium hydrate eyedrops twice daily for 14 days.
Other Names:
  • Bronuck

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Macular edema response rate
Time Frame: 4 weeks after the diode laser photocoagulation
Presence of macular edema
4 weeks after the diode laser photocoagulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conjunctival injection response rate
Time Frame: 4 weeks after the diode laser photocoagulation
Presence of conjunctival injection
4 weeks after the diode laser photocoagulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jeong Hun Kim, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Estimated)

October 20, 2024

Study Completion (Estimated)

October 20, 2024

Study Registration Dates

First Submitted

October 23, 2021

First Submitted That Met QC Criteria

October 23, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2107-210-1239

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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