Ocular InflammationPhase 1/2NCT01190878

Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery Volunteers

A Phase 1/2 study testing ISV-303 and Xibrom™ in people with Ocular Inflammation, run by Sun Pharmaceutical Industries Limited.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-303 compared to vehicle and Xibrom™ when dosed for 2 weeks in post-cataract-surgery volunteers. 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 and Xibrom™
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 169 participants
Where: No sites listed yet
Study dates: Aug 2010to Jan 2011
Phase: Phase 1/2
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

Scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation on the day prior to study enrollment
Meet the best corrected visual acuity score requirement
Meet the IOP requirement
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
Use of any ocular topical, or systemic medication that could interfere with normal lacrimation, wound healing, the test agent, or the interpretation of study results, within 1 week prior to Day of Surgery
Additional exclusion criteria also apply

About this study

Official title: A Randomized Double-masked 14-day Study to Compare the Ocular Safety, Tolerability, and Efficacy of Differing Dosing Regimens of ISV-303 to Vehicle and Xibrom™ in Post Cataract Surgery Volunteers

Conditions: Ocular Inflammation
Being tested: ISV-303, DuraSite Vehicle, Xibrom™

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ISV-303Drug
0.075% of bromfenac in DuraSite dosed QD
ISV-303Drug
0.075% of bromfenac in DuraSite dosed BID
DuraSite VehicleDrug
Vehicle dosed BID
Xibrom™Drug
0.09% bromfenac dosed BID

Study groups in NCT01190878
Study group	Role	What they receive
ISV-303 BID	Experimental	Not described Receives: Drug: ISV-303
ISV-303 QD	Experimental	Not described Receives: Drug: ISV-303
Xibrom BID	Active comparator	Not described Receives: Drug: Xibrom™
DuraSite Vehicle BID	Placebo comparator	Not described Receives: Drug: 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: "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells.
Measured: 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Jan 2011

First posted30 Aug 2010 (estimated)
Study startAug 2010
Primary completionJan 2011
Study completionJan 2011

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.
Publications (1)Papers the sponsor has linked to this study.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 169 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01190878
Sponsor's protocol ID: C-10-303-001
Status last verified: Nov 2021
First submitted: 26 Aug 2010
Last updated: 19 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Trattler W, Hosseini K. Twice-Daily vs. Once-Daily Dosing with 0.075% Bromfenac in DuraSite: Outcomes from a 14-Day Phase 2 Study. Ophthalmol Ther. 2017 Dec;6(2):277-284. doi: 10.1007/s40123-017-0102-x. Epub 2017 Aug 17.
PubMed 28819932

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Ocular Inflammation trials

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 14-day Study to Compare the Ocular Safety, Tolerability, and Efficacy of Differing Dosing Regimens of ISV-303 to Vehicle and Xibrom™ in Post Cataract Surgery Volunteers
ClinicalTrials.gov ID: NCT01190878
Acronym / sponsor ID: C-10-303-001
Conditions: Ocular Inflammation
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 169 participants (actual)
Lead sponsor: Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 30 Aug 2010 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
ISV-303 BID	Experimental	Drug: ISV-303
ISV-303 QD	Experimental	Drug: ISV-303
Xibrom BID	Active comparator	Drug: Xibrom™
DuraSite Vehicle BID	Placebo comparator	Drug: DuraSite Vehicle

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation on the day prior to study enrollment
Meet the best corrected visual acuity score requirement
Meet the IOP requirement
Additional inclusion criteria also apply

Key exclusion criteria (3 listed)

Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications
Use of any ocular topical, or systemic medication that could interfere with normal lacrimation, wound healing, the test agent, or the interpretation of study results, within 1 week prior to Day of Surgery
Additional exclusion criteria also apply

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-3030.075% of bromfenac in DuraSite dosed QD	Drug	ISV-303 QD
ISV-3030.075% of bromfenac in DuraSite dosed BID	Drug	ISV-303 BID
DuraSite VehicleVehicle dosed BID	Drug	DuraSite Vehicle BID
Xibrom™0.09% bromfenac dosed BID	Drug	Xibrom BID

Primary outcome

Ocular Inflammation
Time frame: 15 days
Anterior Chamber Cell Grade 0 at Day 15 measured on a 0 to 4 scale: "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells.

Results and safety

Results posted to the registry on 13 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ISV-303 BID	40	37
ISV-303 QD	45	42
Xibrom BID	42	37
DuraSite Vehicle BID	42	22

Primary outcome: Ocular Inflammation

Time frame: 15 days. Number. Unit: participants

Measure	ISV-303 BID n = 40	ISV-303 QD n = 45	Xibrom BID n = 42	DuraSite Vehicle BID n = 42
Value	21	24	18	8

Population analysed: Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method.

Adverse events

Time frame: 29 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ISV-303 BID	1 of 40 (2.5%)	0 of 40 (0%)	Not reported
ISV-303 QD	0 of 45 (0%)	4 of 45 (8.9%)	Not reported
Xibrom BID	1 of 42 (2.4%)	1 of 42 (2.4%)	Not reported
DuraSite Vehicle BID	0 of 42 (0%)	1 of 42 (2.4%)	Not reported

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.
Derived from this study: PubMed 28819932Trattler W, Hosseini K. Twice-Daily vs. Once-Daily Dosing with 0.075% Bromfenac in DuraSite: Outcomes from a 14-Day Phase 2 Study. Ophthalmol Ther. 2017 Dec;6(2):277-284. doi: 10.1007/s40123-017-0102-x. Epub 2017 Aug 17.

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Blepharitis
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TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
Not yet recruiting
Neurogenetics and Multi-omics of Neuroinflammatory Diseases in Multiplex Families to Improve Patients Health
Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder
Recruiting
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Glaucoma, Corneal Transplantation
Not yet recruiting
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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 1/2 study testing ISV-303 and Xibrom™ 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 4 inclusion and 3 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

On the ClinicalTrials.gov record for NCT01190878, which also lists 1 linked publication.

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.