- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00759239
Phase IV Randomised Double-masked Clinical Trial: Assessing Morning Versus Evening Dosing of a Fixed Dose Combination of Travoprost 0.004% / Timolol Maleate 0.5% in Patients With Primary Open-angle Glaucoma or Ocular Hypertension
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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-
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London, Regno Unito, NW1 5YE
- Western Eye Hospital
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion:
- Male or female adult patients over the age of 18 years
- Current treatment with prostaglandin analogue monotherapy, IOP-lowering medication.
Meet the following IOP entry criteria in at least one treated eye (mean IOP):
- ≥ 19 mmHg
- ≤ 28 mmHg
- The patient is willing and able to sign and date the Informed Consent Form. Patients who wear contact lenses will be able to participate in the study, provided that the contact lenses are removed before instillation of study medication, and that the patient agrees to wait a minimum of 15 minutes, before re-inserting the lenses.
Exclusion:
Females of childbearing potential (i.e. - those who are not surgically sterilised at least three months prior to the study start, or are not at least one year post-menopausal), who are:
- Currently pregnant
- Have a positive result on a urine pregnancy test at the Eligibility Visit
- Intend to become pregnant during the study period
- Are breast-feeding
- Are not using highly effective birth control measures, for example;
- Hormonal - oral, implanted, or injected contraceptives or;
- Mechanical - spermicide in conjunction with a barrier such a condom or diaphragm or;
- Intra-Uterine Device (IUD)
- Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudo-exfoliation component).
- Current or previous therapy with another investigational agent, within 30 days prior to study entry.
- History of chronic or recurrent severe inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis), in either eye.
- History of ocular trauma within the past six months in either eye
- History of ocular infection or ocular inflammation within the past three months in either eye.
- History of clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.
- History of any other severe ocular pathology (including severe dry eyes), in either eye that would preclude the administration of a topical prostaglandin analogue.
- Intraocular surgery within the past six months as determined by patient history and/or examination in either eye.
- Ocular laser surgery within the past three months as determined by patient history and/or examination in either eye.
- Any abnormality preventing reliable applanation tonometry of either eye.
- Angle grade less than Grade 2 in either eye, as measured by gonioscopy (extreme narrow angle with complete or partial closure), assessed within the previous 12 months.
- Cup/disc ratio greater than 0.80 in either eye, assessed within the previous six months.
- Severe central visual field loss in either eye, defined as a sensitivity of ≤ 10 bB in at least two of the four visual field test points, closest to the point of fixation, assessed within the previous six months.
- Unable to safely discontinue all IOP lowering medication, for a minimum period of 28 days prior to Baseline Visit.
- Unable to safely discontinue all glucocorticoid medications administered by any route. Before the Eligibility Visit, patients must have performed a Wash Out of at least four weeks for any intermittent glucocorticoid medications and must be able to remain off these medications for the duration of the study.
- Use of any additional topical or systemic ocular hyposensitive medication during the study.
- History of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
Less than 30 days stable dosing regimen before the Screening Visit of any non-glaucoma medications or substances administered by any route and used on a chronic basis that may affect IOP. These may include, but are not limited to the following:
- Sympathomimetic agents
- Antimuscarinic agents
- Antihistamines
- Phenothiazines
- Tricyclic antidepressants
- Beta-antagonist blocking agents
- Alpha agonists
- Alpha-adrenergic blocking agents
- Calcium channel blockers
- Angiotensin converting enzyme inhibitors
- Cardiac gylcosides
- History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 1
One drop of Travoprost 0.004% / Timolol maleate 0.5% in each eye at 9 am and 1 drop of Timolol vehicle as placebo in each eye at 9 pm for 12 weeks.
|
Solution, morning dosing
Solution, evening dosing
|
Sperimentale: 2
One drop of Timolol vehicle as placebo in each eye at 9 am and one drop of Travoprost 0.004% / Timolol maleate 0.5% in each eye at 9 pm for 12 weeks.
|
Solution, morning dosing
Solution, evening dosing
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Reduction in intraocular pressure
Lasso di tempo: week 4, week 12
|
week 4, week 12
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Adverse events
Lasso di tempo: Week 4, week 12
|
Week 4, week 12
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattia cardiovascolare
- Malattie vascolari
- Malattie degli occhi
- Glaucoma
- Glaucoma, angolo aperto
- Ipertensione oculare
- Ipertensione
- Effetti fisiologici delle droghe
- Beta-antagonisti adrenergici
- Antagonisti adrenergici
- Agenti adrenergici
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Agenti antiaritmici
- Agenti antipertensivi
- Inibitori enzimatici
- Timololo
- Acido maleico
- Travoprost
Altri numeri di identificazione dello studio
- EMD-06-02
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .