2nd Study to Assess ISV-305 Compared to Vehicle for Treatment of Inflammation and Pain Associated With Cataract Surgery (ISV-305)
18 november 2021 uppdaterad av: Sun Pharmaceutical Industries Limited
A Phase 3, Randomized, Multicenter, Double-masked Study to Compare the Ocular Safety, Tolerability, and Efficacy of ISV-305 (0.1% Dexamethasone in DuraSite® 2) to DuraSite 2 Vehicle for the Treatment of Inflammation and Pain Associated With Cataract Surgery
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of ISV-305 (Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of inflammation and pain associated with cataract surgery.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of topical administration of ISV-305 (0.1% dexamethasone in DuraSite® 2) compared with Vehicle when dosed twice daily for 1 day prior to surgery, the day of surgery and 14 days post cataract surgery.
Studietyp
Interventionell
Inskrivning (Faktisk)
246
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Texas
-
Austin, Texas, Förenta staterna, 78731
- Clinical Research Center
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
17 år och äldre (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Are at least 17 years of age
- Are scheduled for uncomplicated unilateral cataract surgery
- Signature of the subject or parent(s) or legally authorized representative on the Informed Consent Form, and when appropriate the minor's assent in accordance with local regulations
- Are willing and able to follow all instructions and attend all study visits
- Are willing to avoid disallowed medication for the duration of the study
- If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing (prior to enrollment and at the end of the study) and use effective contraception for the duration of the study
- Male subjects whose female partners are not post-menopausal must agree to one of the following: 1) completely abstain from sexual intercourse, 2) use a barrier method (condoms) with spermicide during sexual intercourse for the duration of the study, 3) provide documentation for having had a vasectomy (with documented infertility)
- Additional inclusion criteria also apply
Exclusion Criteria:
- Have known sensitivity or poor tolerance to any component of the study drugs
- Have any sign of iritis or scleritis in the study eye
- Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye
- Have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and likely to affect wound healing (e.g., diabetes mellitus, systemic connective tissue disease, severe atopic disease)
- Have known blood dyscrasia or bone marrow suppression
- Have any active corneal pathology in the study eye
- Have had radial keratotomy, corneal transplant, or LASIK in the study eye within the last 2 years
- Be currently pregnant, nursing, or planning a pregnancy; or have a positive urine pregnancy test
- Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
- Have a condition or a situation which, in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
- Use of any medication the investigator feels may interfere with the study parameters
- Additional exclusion criteria also apply
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: ISV-305
0,1 % dexametason i DuraSite® 2
|
Dexametason i DuraSite® 2 två gånger dagligen i 16 dagar
|
|
Placebo-jämförare: Fordon
DuraSite® 2 fordon
|
Fordon två gånger dagligen i 16 dagar
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants With Anterior Chamber Cell Grade 0 in Study Eye at Day 15 (Last Observation Carried Forward) in the Modified Intent to Treat (mITT) Population
Tidsram: Day 15
|
Biomicroscopic measurement of anterior chamber cells was conducted in the surgery eye (study eye) by the same examiner from visit to visit whenever possible.
A slit-lamp biomicroscope was used at x16 magnification with a 1 x 1 mm oblique high-intensity beam.
Two cell counts were summed and divided by 2 to determine an average final anterior chamber cell count.
This final cell count was converted to a grade: Grades 0, 1, 2, 3, 4 were assigned for cell counts of 0, 1 to 10, 11 to 20, 21 to 50, and > 50, respectively.
If the averaged count fell between two grades, the higher grade was selected (e.g., if the two counts were 10 and 11, the average of 10.5 fell into Grade 2).
Missing anterior chamber cell grade at Day 15 was imputed by last non-missing scheduled post-baseline anterior chamber cell grade assessed prior to Day 15 (last observation carried forward).
|
Day 15
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants Who Achieve a Pain Score of 0 on the Visual Analog Scale (VAS) (0-100 mm Scale) for Each Post-surgical Assessment at Days 1, 8, 15, 18, and 29
Tidsram: Day 1 to Day 29
|
Eye pain/discomfort in the study eye was evaluated at every visit except Visit 2 (Surgery; Day 0) using a VAS, scoring from 0 to 100 using a mark on a 100 mm line (0 = absent; 100 = maximum).
Participants were asked to rate the feeling of the symptom in the study eye from absent to extreme by moving a slide on the side of the scale to align with images of descriptive faces.
|
Day 1 to Day 29
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
3 januari 2018
Primärt slutförande (Faktisk)
18 november 2019
Avslutad studie (Faktisk)
18 november 2019
Studieregistreringsdatum
Först inskickad
15 juni 2017
Först inskickad som uppfyllde QC-kriterierna
15 juni 2017
Första postat (Faktisk)
19 juni 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 november 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 november 2021
Senast verifierad
1 november 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- C-16-305-003
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .