Ocular InflammationPhase 3ISV-303NCT01576952
Comparison Study of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects
A Phase 3 study testing ISV-303 in people with Ocular Inflammation, run by Sun Pharmaceutical Industries Limited.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Inflammation
- What is being tested?
- ISV-303
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Jan 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 medication for the duration of the study.
- Willing and able to follow all instructions and attend all study visits
- Able to self-administer study drug (or have a caregiver available to instill all doses of study drug)
- Additional inclusion criteria also apply
Who cannot join
- Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications 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 exclusion criteria also apply
About this study
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
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of topical administration of ISV-303 compared with DuraSite Vehicle.
- Conditions
- Ocular Inflammation
- Being tested
- ISV-303, DuraSite Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISV-303Drug
Bromfenac in DuraSite
DuraSite VehicleOther
DuraSite Vehicle
| Study group | Role | What they receive |
|---|---|---|
| ISV-303 | Experimental | 0.075% bromfenac in DuraSite vehicle dosed BID Receives: Drug: ISV-303 |
| DuraSite Vehicle | Placebo comparator | DuraSite Vehicle dosed BID Receives: Other: DuraSite Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ocular InflammationStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576952
- Sponsor's protocol ID
- C-11-303-003
- Acronym
- ISV-303
- Status last verified
- Nov 2021
- First submitted
- 10 Apr 2012
- Last updated
- 19 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01576952
- Acronym / sponsor ID
- ISV-303 / C-11-303-003
- Conditions
- Ocular Inflammation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 13 Apr 2012 (estimated)
- Results
- Posted 13 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISV-303 | Experimental | Drug: ISV-3030.075% bromfenac in DuraSite vehicle dosed BID |
| DuraSite Vehicle | Placebo comparator | Other: DuraSite VehicleDuraSite Vehicle dosed BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 medication for the duration of the study.
- Willing and able to follow all instructions and attend all study visits
Key exclusion criteria (6 listed)
- Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISV-303Bromfenac in DuraSite | Drug | ISV-303 |
| DuraSite VehicleDuraSite Vehicle | Other | DuraSite Vehicle |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ISV-303 in people with Ocular Inflammation, run by Sun Pharmaceutical Industries Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Inflammation (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.