- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01808547
Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects
November 18, 2021 updated by: Sun Pharmaceutical Industries Limited
A Randomized Double-Masked Study to Compare the Ocular Safety,Tolerability,and Efficacy of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects
The purpose of this study is to evaluate the ocular safety, tolerability and efficacy of topical administration of ISV-303 compared with Durasite Vehicle.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
268
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ISV-303
|
0.075% bromfenac in DuraSite dosed BID
|
Placebo Comparator: Durasite Vehicle
|
DuraSite vehicle dosed BID
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ocular Inflammation
Time Frame: 15 days
|
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.
|
15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
March 7, 2013
First Submitted That Met QC Criteria
March 7, 2013
First Posted (Estimate)
March 11, 2013
Study Record Updates
Last Update Posted (Actual)
November 19, 2021
Last Update Submitted That Met QC Criteria
November 18, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-12-303-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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