Bromfenac Sodium Hydrate Eye Drops in Familial Exudative... | NCT05107921

Studies
Bromfenac Sodium Hydrate Eye Drops in Familial Exudative Vitreoretinopathy

NCT05107921

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Nov 22, 2023Actual

Enrollment

39Estimated

Phase

Phase 2

Conditions

Familial Exudative Vitreoretinopathies

Interventions

Bromfenac Sodium

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2021Actual

Primary Completion Date

Oct 20, 2024Estimated

Completion Date

Oct 20, 2024Estimated

First Submitted Date

Oct 23, 2021

First Submission Date that Met QC Criteria

Oct 23, 2021

First Posted Date

Nov 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2023

Last Update Posted Date

Nov 22, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jeong Hun Kim, Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bromfenac sodium hydrate eye drops	Experimental	The patients will receive bromfenac sodium hydrate eye drops twice daily for 14 days.	Drug: Bromfenac Sodium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bromfenac Sodium	Drug	The study participants will receive bromfenac sodium hydrate eyedrops twice daily for 14 days.	Bromfenac sodium hydrate eye drops

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jeong Hun Kim, MD, PhD	Contact	82-2-2072-3446		steph25@snu.ac.kr

Overall Officials

Name	Affiliation	Role
Jeong Hun Kim, MD, PhD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul		03080	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000080345	Familial Exudative Vitreoretinopathies

Ancestor Terms

ID	Term
D005124	Eye Abnormalities
D005128	Eye Diseases
D015785	Eye Diseases, Hereditary
D012164	Retinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C053083	bromfenac

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided