NCT05107921

UnknownPhase 2

Bromfenac Sodium Hydrate Eye Drops in Familial Exudative Vit...

Seoul National University Hospital Source

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Other study identifiers

Sponsor study identifier

H-2107-210-1239

Study Type

interventional

Estimated enrollment

39

Locations

1 country

Sites

1

Timeline

Study Start

November 1, 2021

Actual (reported)

Primary Completion

October 20, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

October 20, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 39 participants
Study completion date: October 20, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
October 23, 2021
Actual (reported)
Study Start
November 1, 2021
Actual (reported)
First Posted
November 4, 2021
Actual (reported)
Primary Completion
October 20, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 20, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: November 22, 2023
Status Verified: November 2023
Last Update Submitted: November 20, 2023

Conditions

Familial Exudative Vitreoretinopathies

Outcome Measures

Primary Outcomes (1)

Macular edema response rate
Presence of macular edema
4 weeks after the diode laser photocoagulation

Secondary Outcomes (1)

Conjunctival injection response rate
4 weeks after the diode laser photocoagulation

Study Arms (1)

Bromfenac sodium hydrate eye drops

EXPERIMENTAL

The patients will receive bromfenac sodium hydrate eye drops twice daily for 14 days.

Drug: Bromfenac Sodium

Interventions

Bromfenac SodiumDrug

The study participants will receive bromfenac sodium hydrate eyedrops twice daily for 14 days.

Also known as: Bronuck

Bromfenac sodium hydrate eye drops

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age1 Month - 7 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Newly diagnosed patients with familial exudative vitreoretinopathy
Needing diode laser photocoagulation

Sponsors & Collaborators

Seoul National University Hospital
Otherlead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

IRB Support team CenterCONTACT82-2-2072-2613 irb@snuh.org

MeSH Terms

Conditions

Familial Exudative Vitreoretinopathies

Interventions

bromfenac

Condition Hierarchy (Ancestors)

Eye AbnormalitiesEye DiseasesEye Diseases, HereditaryRetinal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Officials

Jeong Hun Kim, MD, PhD
Seoul National University Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeong Hun Kim, MD, PhD

CONTACT

82-2-2072-3446 steph25@snu.ac.kr

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

October 23, 2021

First Posted

November 4, 2021

Study Start

November 1, 2021

Actual (reported)

Primary Completion

October 20, 2024

Estimated (date passed)

Consent to the study

You may not qualify if:

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

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

October 20, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05107921
Data provider: ClinicalTrials.gov
Source updated: 2023-11-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:41 UTC

Locations

KR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Bromfenac sodium hydrate eye drops

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations