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

Effect of topical bromfenac 0.9 mg / ml in the perception of pain after intravitreal injection of drugs

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002155-10-ES

Enrollment

Unknown

Registered

2016-05-30

Start date

2016-05-29

Completion date

Unknown

Last updated

2017-07-03

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

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: 19.0 Level: LLT Classification code 10067261 Term: Ocular pain System Organ Class: 100000004853

Interventions

Trade Name: YELLOX Pharmaceutical Form: Eye drops INN or Proposed INN: BROMFENAC CAS Number: 91714-94-2 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Determine whether administration of bromfenac eye drops 0.9 mg / ml 10 minutes before and after intravitreal injection every 12 hours for three days reduces pain perceived by patients versus placebo.;Secondary Objective: Determine whether administration of bromfenac eye drops 0.9 mg / ml 10 minutes before intravitreal injection reduce pain perceived by patients at yhe moment of the injection, versus placebo.;Primary end point(s): You have completed the survey perceived pain on the third day of injection and have brought in the periodic review of a later month.;Timepoint(s) of evaluation of this end point: 1 month	—

Measure

Time frame

Main Objective: Determine whether administration of bromfenac eye drops 0.9 mg / ml 10 minutes before and after intravitreal injection every 12 hours for three days reduces pain perceived by patients versus placebo.;Secondary Objective: Determine whether administration of bromfenac eye drops 0.9 mg / ml 10 minutes before intravitreal injection reduce pain perceived by patients at yhe moment of the injection, versus placebo.;Primary end point(s): You have completed the survey perceived pain on the third day of injection and have brought in the periodic review of a later month.;Timepoint(s) of evaluation of this end point: 1 month

—

Secondary

Measure	Time frame
Secondary end point(s): Not aplicable;Timepoint(s) of evaluation of this end point: Not aplicable	—

Countries

Spain

Contacts

Public ContactVicente Viruel Begines

FISEVI Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla

adrian.hernandez.sspa@juntadeandalucia.es+34658144396

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026