BlepharitisPhase 3DOUBleNCT01408082
Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis
A Phase 3 study testing ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined), Azasite and Dexamethasone in people with Blepharitis, run by Sun Pharmaceutical Industries Limited at 45 sites in United States.
Trial summary
The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502 compared to AzaSite® alone, Dexamethasone alone, and vehicle in the treatment of subjects with Non-bacterial Blepharitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blepharitis
- What is being tested?
- ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined), Azasite and Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 917 participants
- Where
- 45 sitesUnited States
- Study dates
- Oct 2011to Jun 2013
- Phase
- Phase 3
- 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
- Are at least 18 years of age at Visit 1 (Day 1, Baseline) of either sex and any race.
- Signature of the subject or legally authorized representative on the Informed Consent Form.
- Are willing and able to follow all instructions and attend all study visits.
- Are willing to avoid disallowed medication for the duration of the study.
- If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing. Post menopausal is defined as having no menses for at least 12 consecutive months.
- Additional inclusion criteria also apply.
Who cannot join
- Have known sensitivity or poor tolerance to any component of the Investigational Drug.
- Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation other than Blepharitis in the study eye.
- Have used topical corticosteroid medications or topical ophthalmic solutions that the investigator feels may interfere with the study parameters.
- Have used any non-diagnostic topical ophthalmic solutions in the study eye.
- Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test.
- Currently suffer from alcohol and/or drug abuse.
Show all 9Show fewer
- Have prior (within 30 days of beginning dosing) or anticipated concurrent use of an investigational drug or device.
- Have 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.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
Florida Eye Microsurgicial Institute, Inc.
Boynton Beach, Florida
ZASA Clinical Research, LLC
Boynton Beach, Florida
Arizona Eye Center
Chandler, Arizona
Charlotte Eye Ear Nose & Throat Associates, P.A.
Charlotte, North Carolina
Mundorf Eye Center
Charlotte, North Carolina
Eye Care Associates of Greater Cincinnati, Inc.
Cincinnati, Ohio
Eye Care Associates of Greater Cincinnati, Inc.
Fairfield, Ohio
Center for Sight, Inc.
Fall River, Massachusetts, 02720
Lugene Eye Institute
Glendale, California
Lakeview Optical
Gretna, Louisiana
United Medical Research Institute
Inglewood, California, 90301
Tauber Eye Center
Kansas City, Missouri
Abrams Eye Institute
Las Vegas, Nevada
Nevada Eye Care Professionals
Las Vegas, Nevada
Macy Eye Center
Los Angeles, California, 90048
Richard Eiferman, MD
Louisville, Kentucky
Ophthalmic Consultants of Long Island
Lynbrook, New York
Eye Care Associates of Greater Cincinnati, Inc.
Madeira, Ohio
Total Eye Care, PA
Memphis, Tennessee
North Valley Eye Medical Group, Inc.
Mission Hills, California
Eye Research Foundation
Newport Beach, California
Magruder Eye Institute
Orlando, Florida
Vision Eye Care Center
Palm Springs, Florida
North Bay Associates, Inc.
Petaluma, California
Philadelphia Eye Associates
Philadelphia, Pennsylvania
Arizona Center for Clinical Trials LLC
Phoenix, Arizona
Cornea Consultants of Arizona
Phoenix, Arizona
Martel Eye Medical Group
Rancho Cordova, California, 95670
Shasta Eye Medical Group, Inc.
Redding, California
Ophthalmic Consultants of Long Island
Rockville Centre, New York
Roseburg Research Associates, LLC
Roseburg, Oregon, 97471
Daynes Eye and Lasik
Salt Lake City, Utah, 84103
David Shulman, MD
San Antonio, Texas
Sun Research Institute
San Antonio, Texas
San Diego Eye and Laser Center
San Diego, California, 92123
West Coast Eye Care Associates
San Diego, California
David Ringel, OD PA
Sewell, New Jersey
Eye Care Associates of Nevada
Sparks, Nevada
Ophthalmology Associates
St Louis, Missouri
International Research Center
Tampa, Florida
Ophthalmic Consultants of Long Island
Valley Stream, New York
South Shore Eye Care
Wantagh, New York
Comprehensive Eye Care Ltd
Washington, Missouri
James Branch, MD
Winston-Salem, North Carolina
Research Across America @ Wyomissing Optometric Center Inc
Wyomissing, Pennsylvania
About this study
Official title: A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical Efficacy and Safety of ISV-502 Compared to AzaSite Alone, Dexamethasone Alone, and Vehicle in the Treatment of Subjects With Non-Bacterial Blepharitis
The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502 compared to AzaSite® alone, Dexamethasone alone, and vehicle in the treatment of subjects with Non-bacterial Blepharitis.
- Conditions
- Blepharitis
- Being tested
- ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined), Azasite, Dexamethasone, Vehicle
- Medical subject headings
- Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)Drug
Also called AzaSite Plus
Azithromycin and Dexamethasone twice daily for 2 weeks
AzasiteDrug
Azasite twice daily for 2 weeks
DexamethasoneDrug
Dexamethasone twice daily for 2 weeks
VehicleOther
Vehicle twice daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| ISV-502 | Experimental | Not described Receives: Drug: ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined) |
| AzaSite | Active comparator | Not described Receives: Drug: Azasite |
| Dexamethasone | Active comparator | Not described Receives: Drug: Dexamethasone |
| Vehicle | Placebo comparator | Not described Receives: Other: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Resolution
The primary efficacy endpoint for the comparison of ISV-502 and AzaSite is complete clinical resolution of signs and symptoms at Day 15.
Measured: Day 15
Recurrence of Clinical Signs and Symptoms
The primary efficacy endpoint for the comparison of ISV-502 and Dexamethasone is recurrence of clinical signs and symptoms by 6-Month Follow-up.
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BlepharitisStudies 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
- 917 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
- NCT01408082
- Sponsor's protocol ID
- C-10-502-004
- Acronym
- DOUBle
- Status last verified
- Nov 2021
- First submitted
- 1 Aug 2011
- Last updated
- 19 Nov 2021
- Results posted
- No
Publications
Hosseini K, Bourque LB, Hays RD. Development and evaluation of a measure of patient-reported symptoms of Blepharitis. Health Qual Life Outcomes. 2018 Jan 11;16(1):11. doi: 10.1186/s12955-018-0839-5.
PubMed 29325546
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, Parallel-Group, Comparative Study to Evaluate the Clinical Efficacy and Safety of ISV-502 Compared to AzaSite Alone, Dexamethasone Alone, and Vehicle in the Treatment of Subjects With Non-Bacterial Blepharitis
- ClinicalTrials.gov ID
- NCT01408082
- Acronym / sponsor ID
- DOUBle / C-10-502-004
- Conditions
- Blepharitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 917 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 3 Aug 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 clinical efficacy and safety of ISV-502 compared to AzaSite® alone, Dexamethasone alone, and vehicle in the treatment of subjects with Non-bacterial Blepharitis.
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-502 | Experimental | Drug: ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined) |
| AzaSite | Active comparator | Drug: Azasite |
| Dexamethasone | Active comparator | Drug: Dexamethasone |
| Vehicle | Placebo comparator | Other: Vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are at least 18 years of age at Visit 1 (Day 1, Baseline) of either sex and any race.
- Signature of the subject or legally authorized representative on the Informed Consent Form.
- Are willing and able to follow all instructions and attend all study visits.
- Are willing to avoid disallowed medication for the duration of the study.
- If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing. Post menopausal is defined as having no menses for at least 12 consecutive months.
Key exclusion criteria (9 listed)
- Have known sensitivity or poor tolerance to any component of the Investigational Drug.
- Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation other than Blepharitis in the study eye.
- Have used topical corticosteroid medications or topical ophthalmic solutions that the investigator feels may interfere with the study parameters.
- Have used any non-diagnostic topical ophthalmic solutions in the study eye.
- Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test.
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-502 (1.0% azithromycin and 0.1% dexamethasone combined)Also: AzaSite PlusAzithromycin and Dexamethasone twice daily for 2 weeks | Drug | ISV-502 |
| AzasiteAzasite twice daily for 2 weeks | Drug | AzaSite |
| DexamethasoneDexamethasone twice daily for 2 weeks | Drug | Dexamethasone |
| VehicleVehicle twice daily for 2 weeks | Other | Vehicle |
Primary outcome
Clinical Resolution
Time frame: Day 15
The primary efficacy endpoint for the comparison of ISV-502 and AzaSite is complete clinical resolution of signs and symptoms at Day 15.
Recurrence of Clinical Signs and Symptoms
Time frame: 6 Month
The primary efficacy endpoint for the comparison of ISV-502 and Dexamethasone is recurrence of clinical signs and symptoms by 6-Month Follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Derived from this study: PubMed 29325546Hosseini K, Bourque LB, Hays RD. Development and evaluation of a measure of patient-reported symptoms of Blepharitis. Health Qual Life Outcomes. 2018 Jan 11;16(1):11. doi: 10.1186/s12955-018-0839-5.
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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.
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined), Azasite and Dexamethasone in people with Blepharitis, run by Sun Pharmaceutical Industries Limited at 45 sites in United States.
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 6 inclusion and 9 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.
Where is the study taking place?
The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Resolution (time frame: Day 15). 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?
On the ClinicalTrials.gov record for NCT01408082, 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.