Dry Eye DiseasePhase 2ISV-101NCT01478555
A Dose-Finding Study Comparing InSite Vision, Inc. 101 to Vehicle and DuraSite Alone for Dry Eye Disease
A Phase 2 study testing ISV 101 in people with Dry Eye Disease, run by Sun Pharmaceutical Industries Limited.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-101 (Bromfenac in DuraSite® ophthalmic solution) compared to Vehicle and DuraSite alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- ISV 101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Jan 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Volunteers 18 years of age and older who have a diagnosis of moderate to severe dry eye disease.
- Negative pregnancy test prior to the conduct of any protocol-specific procedure. 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.
- Able to self-administer study drug (or have a caregiver available to instill all doses of study drug)
- Able and willing to follow study instructions
- Additional inclusion criteria also apply
Who cannot join
- Females who are pregnant or nursing. Females of childbearing potential (not surgically sterilized or postmenopausal) may not participate in the study if they do not agree to use adequate birth control methods for the duration of the study).
- Use of contact lenses during the study.
- Use of any concomitant topical ocular medications except for artificial tears during the dosing period
- Presence or history of treatment with systemic immunosuppressive or chemotherapeutic agents.
- Prior or anticipated concurrent use of an investigational product or device that could confound the findings about Dry Eye in the study eye.
- 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
Show all 13Show fewer
- Known hypersensitivity to any component of the study drug or procedural medications
- Participation in any other clinical trial within 30 days prior to screening
- Known hypersensitivity to NSAIDS
- Any active corneal epithelial/stromal pathology noted in the study eye at the screening visit
- Any history of corneal surgery (including corneal crosslinking, radial keratotomy, corneal transplant, or LASIK)
- Cataract surgery within the past year.
- Known contraindication to the study drugs or any of their components
About this study
Official title: A Dose-Finding Study To Compare The Safety, Tolerability, And Efficacy Of Differing Dosing Regimens Of ISV-101 (Bromfenac In DuraSite® Ophthalmic Solution) To Vehicle And DuraSite Alone In Dry Eye Disease Volunteers
The purpose of this study is to evaluate the safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-101 (Bromfenac in DuraSite® ophthalmic solution) compared to Vehicle and DuraSite alone.
- Conditions
- Dry Eye Disease
- Being tested
- ISV 101
- Keywords
- Dry Eye
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISV 101Drug
Bromfenac in DuraSite
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 of Bromfenac in DuraSite | Experimental | Not described Receives: Drug: ISV 101 |
| Dose 2 of Bromfenac in DuraSite | Experimental | Not described Receives: Drug: ISV 101 |
| Dose 3 of Bromfenac in DuraSite | Experimental | Not described Receives: Drug: ISV 101 |
| DuraSite | Active comparator | Not described Receives: Drug: ISV 101 |
| Vehicle | Active comparator | Not described Receives: Drug: ISV 101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Corneal Fluorescein Staining
Measured: Week 8
Improvement in OSDI Scoring
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startJan 2018 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionJan 2019 (estimated)
Why it stopped: Project postponed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 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
- NCT01478555
- Sponsor's protocol ID
- C-10-101-001
- Acronym
- ISV-101
- Status last verified
- Nov 2021
- First submitted
- 24 Oct 2011
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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 Dose-Finding Study To Compare The Safety, Tolerability, And Efficacy Of Differing Dosing Regimens Of ISV-101 (Bromfenac In DuraSite® Ophthalmic Solution) To Vehicle And DuraSite Alone In Dry Eye Disease Volunteers
- ClinicalTrials.gov ID
- NCT01478555
- Acronym / sponsor ID
- ISV-101 / C-10-101-001
- Conditions
- Dry Eye Disease
- Keywords
- Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project postponed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Not posted in the source record
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 safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-101 (Bromfenac in DuraSite® ophthalmic solution) compared to Vehicle and DuraSite alone.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose 1 of Bromfenac in DuraSite | Experimental | Drug: ISV 101 |
| Dose 2 of Bromfenac in DuraSite | Experimental | Drug: ISV 101 |
| Dose 3 of Bromfenac in DuraSite | Experimental | Drug: ISV 101 |
| DuraSite | Active comparator | Drug: ISV 101 |
| Vehicle | Active comparator | Drug: ISV 101 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Volunteers 18 years of age and older who have a diagnosis of moderate to severe dry eye disease.
- Negative pregnancy test prior to the conduct of any protocol-specific procedure. 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.
- Able to self-administer study drug (or have a caregiver available to instill all doses of study drug)
Key exclusion criteria (13 listed)
- Females who are pregnant or nursing. Females of childbearing potential (not surgically sterilized or postmenopausal) may not participate in the study if they do not agree to use adequate birth control methods for the duration of the study).
- Use of contact lenses during the study.
- Use of any concomitant topical ocular medications except for artificial tears during the dosing period
- Presence or history of treatment with systemic immunosuppressive or chemotherapeutic agents.
- Prior or anticipated concurrent use of an investigational product or device that could confound the findings about Dry Eye in the study eye.
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 101Bromfenac in DuraSite | Drug | Dose 1 of Bromfenac in DuraSite, Dose 2 of Bromfenac in DuraSite, Dose 3 of Bromfenac in DuraSite, DuraSite, Vehicle |
Primary outcome
Improvement in Corneal Fluorescein Staining
Time frame: Week 8
Improvement in OSDI Scoring
Time frame: Week 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
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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 2 study testing ISV 101 in people with Dry Eye Disease, 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 13 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: withdrawn, 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. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Improvement in Corneal Fluorescein Staining (time frame: Week 8). The study lists 2 primary outcomes in all. 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.