Effect of topical bromfenac in the perception of pain after intravitreal injection of drugs

Phase 1

Active, not recruiting

• Conditions: Following the intravitreal injection of various drugs, very common procedure in clinical practice in ophthalmology, pain often occurs to varying degrees, although in most cases it is a painless procedure. This pain can occur both at the time of injection, caused by the same despite the anesthetic eye drops, and in subsequent days conjunctivitis irritant topical betadine.; MedDRA version: 19.0Level: LLTClassification code 10067261Term: Ocular painSystem Organ Class: 100000004853; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2015-002155-10-ES
• Lead Sponsor: FISEVI Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-30
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patient in need intravitreal injection of drugs through 30 gauge needle.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Be the first intravitreal injection to the patient
Allergy to any component of bromfenac eye drops 0.9 mg / ml
Not understand the pain survey
No pain perform surveys N1 and N2
N2 not bring pain survey
Refusal to sign the informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified