E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
Tras la inyección intravítrea de diversos medicamentos, procedimiento muy habitual en la práctica clínica en oftalmología, en muchas ocasiones se produce dolor en diversos grados, aunque en la mayoría de las ocasiones es un procedimiento indoloro. Este dolor se puede producir tanto en el momento de la inyección, provocado por la misma a pesar de los colirios anestésicos, como en los días posteriores por conjuntivitis irritativa por el betadine tópico. |
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E.1.1.1 | Medical condition in easily understood language |
Eye pain after intravitreal injection of drugs |
Dolor ocular tras la inyección intravítrea de medicamentos. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067261 |
E.1.2 | Term | Ocular pain |
E.1.2 | System Organ Class | 100000004853 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Determinar si la administración de colirio de bromfenaco 0,9 mg/ml 10 minutos antes de la inyección intravítrea y despues cada 12 horas durante 3 días disminuye el dolor percibido por los pacientes frente a placebo. |
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E.2.2 | Secondary objectives of the trial |
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. |
Determinar si la administración de colirio de bromfenaco 0,9 mg/ml 10 minutos antes de la inyección intravítrea disminuye el dolor percibido por los pacientes en el momento de la inyección, frente a placebo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patient in need intravitreal injection of drugs through 30 gauge needle. |
Paciente que precisa inyección intravitrea de medicamentos mediante aguja de 30 gauges. |
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E.4 | Principal 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 |
Ser la primera inyección intravítrea que recibe el paciente Alergia a cualquier componente de colirio bromfenaco 0.9 mg/ml No comprender la encuesta del dolor No realizar la encuestas del dolor N1 y N2 No traer las encuesta N2 de dolor Rechazo a firmar el consentimiento informado |
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E.5 End points |
E.5.1 | 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. |
Haber completado la encuesta sobre dolor percibido al tercer día de la inyección y haberla traído en la revisión periódica de un mes posterior. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Not aplicable |
No aplicable |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not aplicable |
No aplicable |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |