An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert (OLE2)
26 maart 2019 bijgewerkt door: 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).
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
81
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Arkansas
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Fayetteville, Arkansas, Verenigde Staten, 72704
- Vold Vision
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California
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Artesia, California, Verenigde Staten, 90701
- Sall Medical Research Center
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Newport Beach, California, Verenigde Staten, 92663
- Eye Research Foundation
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Georgia
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Morrow, Georgia, Verenigde Staten, 30260
- Clayton Eye Center
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North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28204
- Mundorf Eye Center
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High Point, North Carolina, Verenigde Staten, 27262
- Cornerstone Health Care; Cornerstone Eye Care
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Tennessee
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Maryville, Tennessee, Verenigde Staten, 37803
- University Eye Specialists
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Memphis, Tennessee, Verenigde Staten, 38119
- Total Eye Care
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Texas
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San Antonio, Texas, Verenigde Staten, 78229
- R&R Eye Research, LLC
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
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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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity
Tijdsspanne: Baseline (Day 0, enrollment in this study) to end of study (Week 38)
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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)
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change From Baseline in Intraocular Pressure (IOP)
Tijdsspanne: Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38
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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
Tijdsspanne: Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38
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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
Tijdsspanne: Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
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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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
10 augustus 2015
Primaire voltooiing (Werkelijk)
11 augustus 2016
Studie voltooiing (Werkelijk)
11 augustus 2016
Studieregistratiedata
Eerst ingediend
27 augustus 2015
Eerst ingediend dat voldeed aan de QC-criteria
28 augustus 2015
Eerst geplaatst (Schatting)
1 september 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 april 2019
Laatste update ingediend die voldeed aan QC-criteria
26 maart 2019
Laatst geverifieerd
1 maart 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- FSV5-005 OLE 2
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .