An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert (OLE2)
26 mars 2019 mis à jour par: ForSight Vision5, Inc.
An Open-label Extension (OLE 2) Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert in Subjects With Open-angle Glaucoma or Ocular Hypertension Who Have Completed Study FSV5-004
This study evaluated the long-term (9-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-004.
All the participants received Bimatoprost Ocular Insert and wore it for approximately 3 months (12 weeks), then had that Insert removed and a new Insert placed for another 26 weeks (approximately 6 months).
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
81
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Arkansas
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Fayetteville, Arkansas, États-Unis, 72704
- Vold Vision
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California
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Artesia, California, États-Unis, 90701
- Sall Medical Research Center
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Newport Beach, California, États-Unis, 92663
- Eye Research Foundation
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Georgia
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Morrow, Georgia, États-Unis, 30260
- Clayton Eye Center
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North Carolina
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Charlotte, North Carolina, États-Unis, 28204
- Mundorf Eye Center
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High Point, North Carolina, États-Unis, 27262
- Cornerstone Health Care; Cornerstone Eye Care
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Tennessee
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Maryville, Tennessee, États-Unis, 37803
- University Eye Specialists
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Memphis, Tennessee, États-Unis, 38119
- Total Eye Care
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Texas
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San Antonio, Texas, États-Unis, 78229
- R&R Eye Research, LLC
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Completed FSV5-004 study.
- Written informed consent prior to any study procedure.
- Willingness to comply with the visit schedule.
Key Exclusion Criteria:
- Participation in an investigational drug or device study other than FSV5-004 within the past 6 months or anticipated participation during the study period.
- Subjects who will require contact lens use during the study period.
- Any condition or situation (such as uncontrolled systemic disease) that, in the Investigator's opinion, might confound the results of the study, may put the subject at significant risk or might interfere with the subject's ability to participate in the study.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 13 mg Bimatoprost Ocular Insert
13 mg Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new 13 mg Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.
|
Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity
Délai: Baseline (Day 0, enrollment in this study) to end of study (Week 38)
|
An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study.
An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye.
The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.
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Baseline (Day 0, enrollment in this study) to end of study (Week 38)
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline in Intraocular Pressure (IOP)
Délai: Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38
|
IOP is a measurement of the fluid pressure inside the eye.
IOP measurements were taken at 8 am (Time (T)=0 hour) at Weeks 4, 8, 12, 24 and 38.
Diurnal IOP measurements were also taken at 10 am (T=2 hour), and 4 pm (T=8 hour) at Weeks 12, 24 and 38.
IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint.
A negative change from Baseline indicated an improvement.
Baseline is defined as the IOP assessment done at the Randomization visit (Day 0) of study FSV5-004.
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Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38
|
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Percentage of Participants by Subject-Reported Comfort Assessment Categories
Délai: Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38
|
The participant assessed their overall comfort with ocular inserts using the following rating choices: Not aware of inserts, very comfortable; Aware of inserts, and comfortable; Tolerable, but mild discomfort; Moderate discomfort or Severe discomfort.
The percentage of participants in each rating category is reported.
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Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38
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Bimatoprost Ocular Insert Retention Duration
Délai: Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
|
Insert duration was defined as the total duration (in days) that any ocular insert remained in place for each subject, measured from the date of Insert removal minus date of Insert placement + 1.
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Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
|
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Percentage of Participants Who Received Rescue Treatment
Délai: Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
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Rescue treatment with topical bimatoprost was available for each eye if deemed necessary by the investigator to achieve desired IOP.
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Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
|
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Change From Baseline in Endothelial Cell Count
Délai: Baseline (Day 0, enrollment in this study) to end of study (Week 38)
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Density (number of cells/mm^2) of corneal endothelial cells was determined at four sites using specular microscopy of the central corneal endothelium at Baseline and at Week 38.
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Baseline (Day 0, enrollment in this study) to end of study (Week 38)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
10 août 2015
Achèvement primaire (Réel)
11 août 2016
Achèvement de l'étude (Réel)
11 août 2016
Dates d'inscription aux études
Première soumission
27 août 2015
Première soumission répondant aux critères de contrôle qualité
28 août 2015
Première publication (Estimation)
1 septembre 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 avril 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 mars 2019
Dernière vérification
1 mars 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FSV5-005 OLE 2
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .