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Bromfenac Sodium Hydrate Eye Drops in Familial Exudative Vitreoretinopathy

Sponsor
Seoul National University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05107921
Collaborator
(none)
39
Enrollment
1
Arm
26
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bromfenac Sodium
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
39 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Bromfenac Sodium Hydrate Eye Drops in Children With Familial Exudative Vitreoretinopathy After Diode Laser Photocoagulation
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Macular edema response rate [4 weeks after the diode laser photocoagulation]

      Presence of macular edema

    Secondary Outcome Measures

    1. Conjunctival injection response rate [4 weeks after the diode laser photocoagulation]

      Presence of conjunctival injection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 7 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeong Hun Kim, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT05107921
    Other Study ID Numbers:
    • H-2107-210-1239
    First Posted:
    Nov 4, 2021
    Last Update Posted:
    Nov 4, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Familial Exudative Vitreoretinopathies
    Retinal Diseases
    Bromfenac

    Study Results

    No Results Posted as of Nov 4, 2021