Back to resultsComparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects
Primary Purpose
Ocular Inflammation
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ISV-303
DuraSite Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Inflammation
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects age 18 or older scheduled for unilateral cataract surgery with posterior chamber intraocular lens implantation
- If a female is of childbearing potential, the subject must agree to and submit a negative pregnancy test before any protocol-specific procedures are conducted. The subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months
- Signature of the subject on the Informed Consent Form
- Willing to avoid disallowed medications for the duration of the study
- Willing and able to follow all instructions and attend all study visits
- Able to self-administer the IMP (or have a caregiver available to instill all doses of study drugs )
- Additional inclusion criteria also apply
Exclusion Criteria:
- Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the IMP or any of the procedural medications
- Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
- Currently suffer from alcohol and/or drug abuse
- Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
- 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
- Additional inclusion criteria also apply
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ISV-303
Durasite Vehicle
Arm Description
Outcomes
Primary Outcome Measures
Ocular Inflammation
Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells, and no rescue medications.
Secondary Outcome Measures
Full Information
NCT ID
NCT01808547
First Posted
March 7, 2013
Last Updated
November 18, 2021
Sponsor
Sun Pharmaceutical Industries Limited
1. Study Identification
Unique Protocol Identification Number
NCT01808547
Brief Title
Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects
Official Title
A Randomized Double-Masked Study to Compare the Ocular Safety,Tolerability,and Efficacy of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharmaceutical Industries Limited
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the ocular safety, tolerability and efficacy of topical administration of ISV-303 compared with Durasite Vehicle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
268 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ISV-303
Arm Type
Experimental
Arm Title
Durasite Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ISV-303
Intervention Description
0.075% bromfenac in DuraSite dosed BID
Intervention Type
Other
Intervention Name(s)
DuraSite Vehicle
Intervention Description
DuraSite vehicle dosed BID
Primary Outcome Measure Information:
Title
Ocular Inflammation
Description
Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells, and no rescue medications.
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects age 18 or older scheduled for unilateral cataract surgery with posterior chamber intraocular lens implantation
If a female is of childbearing potential, the subject must agree to and submit a negative pregnancy test before any protocol-specific procedures are conducted. The subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months
Signature of the subject on the Informed Consent Form
Willing to avoid disallowed medications for the duration of the study
Willing and able to follow all instructions and attend all study visits
Able to self-administer the IMP (or have a caregiver available to instill all doses of study drugs )
Additional inclusion criteria also apply
Exclusion Criteria:
Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the IMP or any of the procedural medications
Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
Currently suffer from alcohol and/or drug abuse
Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
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
Additional inclusion criteria also apply
12. IPD Sharing Statement
Learn more about this trial
Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects
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