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Bromfenac Sodium Hydrate Eye Drops in Familial Exudative Vitreoretinopathy

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05107921
Enrollment
39
Registered
2021-11-04
Start date
2021-11-01
Completion date
2024-10-20
Last updated
2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial Exudative Vitreoretinopathies

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.

Interventions

DRUGBromfenac Sodium

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Macular edema response rate4 weeks after the diode laser photocoagulationPresence of macular edema

Secondary

MeasureTime frameDescription
Conjunctival injection response rate4 weeks after the diode laser photocoagulationPresence of conjunctival injection

Countries

South Korea

Contacts

Primary ContactJeong Hun Kim, MD, PhD
steph25@snu.ac.kr82-2-2072-3446

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026