E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
open-angle glaucoma or ocular hypertension who are currently on latanoprost 0.005 or bimatoprost 0.01 ophthalmic solution monotherapy |
diagnosi di glaucoma ad angolo aperto o con ipertensione oculare che sono attualmente trattati con soluzione oftalmica di latanoprost 0,005 o bimatoprost 0,01 in monoterapia |
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E.1.1.1 | Medical condition in easily understood language |
open-angle glaucoma or ocular hypertension who are currently on latanoprost or bimatoprost ophthalmic solution monotherapy |
glaucoma ad angolo aperto o con ipertensione oculare che sono attualmente trattati con soluzione oftalmica di latanoprost o bimatoprost in monoterapia |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10018305 |
E.1.2 | Term | Glaucomas (excl congenital) |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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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 |
to assess the efficacy and tolerability of TRAVATAN Solution without
BAK, containing Polyquad Preservative after changing from prior latanoprost 0.005% or bimatoprost
0.01 ophthalmic solution monotherapy |
valutare l'efficacia e la tollerabilità di TRAVATAN Solution senza BAK, contenente Conservante Polyquad dopo il passaggio da una terapia con soluzione oftalmica di latanoprost 0,005 o bimatoprost 0,01 in monoterapia. |
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E.2.2 | Secondary objectives of the trial |
It's the evaluation of the percentages of of patients who reach target IOP (≤ 18 mmHg). Lastly, Changes in Ocular Surface Disease Index scores, hyperemia levels, as well as patient Questionnaires are considered as the exploratory variables of the study. |
valutazione delle percentuali di pazienti che raggiungono l'obiettivo IOP(≤ 18 mmHg.I cambiamenti nei punteggi Ocular Surface Disease Index, i livelli di iperemia, così come I questionari paziente sono considerati come variabili esplorative dello studio |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Must have a clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye. 3. Must be on either latanoprost 0.005 or bimatoprost 0.01 ophthalmic solution monotherapy (including BAK containing generics) for at least 4 weeks prior the Screening Visit but, in the opinion of the investigator, would benefit from a switch to TRAVATAN Solution without BAK, containing Polyquad Preservative because of tolerability issues. 4. IOP less than 30 mmHg in both eyes while on latanoprost 0.005 or bimatoprost 0.01 ophthalmic solution monotherapy. 5. Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period. 6. In the eye that is not included in the study, the IOP should be able to be controlled on no pharmacologic therapy or on the study medicine alone. 7. Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study. 8. Must be able to follow instructions and be willing and able to attend all study visits. 9. Must have best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye. |
-Devono presentare una diagnosi clinica di ipertensione oculare o glaucoma ad angolo aperto in almeno un occhio. - Devono essere trattati con soluzione oftalmica di latanoprost 0,005% o bimatoprost 0,01 in monoterapia (compresi farmaci generici contenenti BAK) per almeno 4 settimane prima della visita di screening, ma che, a giudizio del ricercatore, trarrebbero beneficio da un passaggio a TRAVATAN Soluzione senza BAK, contenente Conservante Polyquad per via di problemi di tollerabilità. - PIO inferiore a 30 mmHg in entrambi gli occhi, durante l'assunzione di soluzione oftalmica di latanoprost 0,005 o bimatoprost 0,01 in monoterapia. - Devono avere una PIO ritenuta sicura (a giudizio del ricercatore) in entrambi gli occhi, in modo tale da garantire stabilità clinica della visione e del nervo ottico per tutto il periodo di studio. - Nell'occhio non incluso nello studio, la PIO non dovrebbe essere in grado di essere controllata con alcuna terapia farmacologica né con il solo farmaco oggetto di studio. - Devono essere disposti a sospendere l'uso di tutti gli altri farmaci ipotensivi oculari altre prima di assumere il farmaco in studio per l'intero corso dello studio. - Devono essere in grado di seguire le istruzioni ed essere disposti e in grado di partecipare a tutte le visite dello studio. - Devono avere una migliore acuità visiva corretta Snellen di 6/60 (20/200, 1,0 LogMAR) o superiore in ciascun occhio. |
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E.4 | Principal exclusion criteria |
-Known medical history of allergy, hypersensitivity or poor tolerance to any components of the preparations to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator. Any abnormality preventing reliable applanation tonometry in either eye. 3. Corneal dystrophies in either eye. 4. Any opacity or patient uncooperativeness that restricts adequate examination of the anterior chamber of either eye. 5. Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. 6. Severe dry eye, or 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. 7. Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit. 8. Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator’s best judgment. 9. Progressive retinal or optic nerve disease from any cause. 10. A history of, or at risk for uveitis or cystoid macular edema (CME). 11. Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alphaagonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for at least 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study. 12. Any clinically significant, serious, or severe medical condition. 13. Women of childbearing potential not using reliable means of birth control. A reliable effective method of birth control must have been used for at least one month prior to Visit 1 and is defined as those which result in a low failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed. 14. Women who are pregnant or lactating 15. A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient. 16.Participation in any other investigational study within 30 days prior to the Screening Visit. |
- Storia pregressa di allergia, ipersensibilità o scarsa tolleranza a qualsiasi componente dei preparati da utilizzare in questo studio che sia ritenuta clinicamente significativa a giudizio del Ricercatore Principale. - Qualsiasi anomalia che prevenga una affidabile tonometria ad applanazione in uno dei due occhi. - Distrofie corneali in uno dei due occhi. - Qualsiasi opacità o mancanza di collaborazione del paziente che limita un esame adeguato della camera anteriore in uno degli occhi. - Congiuntivite infettiva/non infettiva, cheratite o uveite concomitante in uno degli occhi. - Grave secchezza oculare, od occhio secco o cheratocongiuntivite secca che sia stata o sia attualmente trattata con l'utilizzo di tappi per puntini lacrimali, cauterio del puntino lacrimale, Restasis , o corticosteroidi topici oculari. - Chirurgia convenzionale o chirurgia laser intraoculare in uno degli occhi risalente a meno di tre mesi prima della Visita di Screening. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in IOP at the 12 week visit from prior latanoprost or bimatoprost 0.01 ophthalmic solution monotherapy (baseline). |
CAMBIO DELLA PRESSIONE INTRAOCULARE DOPO 12 SETTIMANE DI TRATTAMENTO RISPETTO ALLA MONOTERAPIA CON LATANOPROST O BIMATOPROST(basale) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
FTER 12 WEEKS OF THE TREATMENT |
DOPO LE 12 SETTIMANE DI TRATTAMENTO |
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E.5.2 | Secondary end point(s) |
Percentage of patients who reach target IOP (≤ 18 mmHg). |
pERCENTUALe DI PAZIENTI CHE RAGGIUNGONO UNA PRESSIONE INTRAOCULARE INFERIORE A 18 mmHg. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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
|
October-November 2012 |
Ottobre-Novembre 2012 |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 14 |
E.8.9.2 | In all countries concerned by the trial days | 0 |