- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01510145
Efficacy of Changing to TRAVATAN® From Prior Therapy
15. maj 2014 opdateret af: Alcon Research
Multi-Center Study Comparing Efficacy and Tolerability of TRAVATAN® BAK-free (0.004% Travoprost) in Patients Previously on Latanoprost Ophthalmic Solution 0.005% Monotherapy
The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® solution without BAK (benzalkonium chloride) after changing from prior latanoprost 0.005% ophthalmic solution monotherapy in subjects with open-angle glaucoma or ocular hypertension due to tolerability issues.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
191
Fase
- Fase 4
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye;
- On latanoprost ophthalmic solution 0.005% monotherapy (including BAK-containing generics) for at least 4 weeks prior to the Screening Visit, but would benefit from a switch to TRAVATAN® BAK-free because of tolerability issues, in the opinion of the investigator;
- Intraocular pressure (IOP) <30 millimeters of mercury (mmHg) in both eyes while on latanoprost ophthalmic solution 0.005% monotherapy;
- IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that assured clinical stability of vision and the optic nerve throughout the study period;
- Willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study;
- Able to follow instructions and willing and able to attend all study visits;
- Best corrected Snellen visual acuity of 6/60 (20/200; 1.0 LogMAR) or better in each eye;
- Must sign an informed consent form;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study deemed clinically significant in the opinion of the Principal Investigator;
- Any abnormality preventing reliable applanation tonometry in either eye;
- Corneal dystrophies in either eye;
- Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye;
- Any clinically significant, serious, or severe medical condition;
- Use of any systemic medications known to affect IOP which have not been on a stable course for at least 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study;
- Severe dry eye or keratoconjunctivitis sicca which has been or is currently being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids;
- Intraocular conventional surgery or laser surgery in either eye less than 3 months prior to the Screening Visit;
- Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment;
- Progressive retinal or optic nerve disease from any cause;
- Women who are pregnant, lactating, or not using reliable means of birth control;
- Other protocol-defined exclusion criteria may apply.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: TRAVATAN® BAK-free
Travoprost 0.004% BAK-free, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
|
Containing Polyquad (PQ) preservative
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)
Tidsramme: Baseline, Week 12
|
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry.
A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage).
A more negative change indicates a greater amount of improvement.
One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
|
Baseline, Week 12
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Subjects Who Reach Target IOP (≤18 mmHg)
Tidsramme: Week 12
|
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry.
A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage).
One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
|
Week 12
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Adriana S. Bonadia, Alcon Research
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2012
Primær færdiggørelse (Faktiske)
1. maj 2013
Studieafslutning (Faktiske)
1. maj 2013
Datoer for studieregistrering
Først indsendt
11. januar 2012
Først indsendt, der opfyldte QC-kriterier
11. januar 2012
Først opslået (Skøn)
13. januar 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. juni 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. maj 2014
Sidst verificeret
1. maj 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RDG-10-300
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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