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Comparative Study to Evaluate ISV-305 Compared to Vehicle for the Treatment of Inflammation and Pain Associated With Cataract Surgery (ISV-305)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03192137
Recruitment Status : Active, not recruiting
First Posted : June 19, 2017
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
InSite Vision

Tracking Information
First Submitted Date  ICMJE June 15, 2017
First Posted Date  ICMJE June 19, 2017
Last Update Posted Date October 18, 2019
Actual Study Start Date  ICMJE January 30, 2018
Actual Primary Completion Date June 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
Anterior Chamber Cell Grade 0 [ Time Frame: Day 15 ]
Primary efficacy endpoint for the comparison of ISV-305 and Vehicle
Original Primary Outcome Measures  ICMJE
 (submitted: June 15, 2017)
Anterior Chamber Cell Grade of 0 [ Time Frame: Day 15 ]
The primary efficacy endpoint for the comparison of ISV-305 and Vehicle is complete.
Change History Complete list of historical versions of study NCT03192137 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Study to Evaluate ISV-305 Compared to Vehicle for the Treatment of Inflammation and Pain Associated With Cataract Surgery
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Inflammation and Pain Associated With Cataract Surgery
Intervention  ICMJE
  • Drug: ISV-305
    Dexamethasone in DuraSite® 2 twice daily for 16 days
  • Other: Vehicle
    Placebo twice daily for 16 days
Study Arms  ICMJE
  • Experimental: ISV-305
    Intervention: Drug: ISV-305
  • Placebo Comparator: Vehicle
    Intervention: Other: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2017)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Actual Primary Completion Date June 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03192137
Other Study ID Numbers  ICMJE C-13-305-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InSite Vision
Study Sponsor  ICMJE InSite Vision
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account InSite Vision
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP