Bromfenac Sodium Hydrate Eye Drops in Familial Exudative Vitreoretinopathy

NCT ID: NCT05107921

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2024-10-20

Brief Summary

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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

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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.

Conditions

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Familial Exudative Vitreoretinopathies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bromfenac sodium hydrate eye drops

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

Group Type EXPERIMENTAL

Bromfenac Sodium

Intervention Type DRUG

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

Interventions

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Bromfenac Sodium

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

Intervention Type DRUG

Other Intervention Names

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Bronuck

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Hun Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Hun Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jeong Hun Kim, MD, PhD

Role: CONTACT

82-2-2072-3446

Facility Contacts

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IRB Support team Center

Role: primary

82-2-2072-2613

Other Identifiers

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H-2107-210-1239

Identifier Type: -

Identifier Source: org_study_id