Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis (DOUBle)
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| ClinicalTrials.gov Identifier: NCT01408082 |
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Recruitment Status :
Completed
First Posted : August 3, 2011
Last Update Posted : October 25, 2019
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Sponsor:
Sun Pharma Global FZE
Information provided by (Responsible Party):
Sun Pharma Global FZE
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Blepharitis | Drug: ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined) Drug: Azasite Drug: Dexamethasone Other: Vehicle | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 917 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | October 2011 |
| Actual Primary Completion Date : | March 2013 |
| Actual Study Completion Date : | June 2013 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: ISV-502 |
Drug: ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)
Azithromycin and Dexamethasone twice daily for 2 weeks
Other Name: AzaSite Plus |
| Active Comparator: AzaSite |
Drug: Azasite
Azasite twice daily for 2 weeks |
| Active Comparator: Dexamethasone |
Drug: Dexamethasone
Dexamethasone twice daily for 2 weeks |
| Placebo Comparator: Vehicle |
Other: Vehicle
Vehicle twice daily for 2 weeks |
Primary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01408082
Locations
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Sponsors and Collaborators
Sun Pharma Global FZE
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sun Pharma Global FZE |
| ClinicalTrials.gov Identifier: | NCT01408082 |
| Other Study ID Numbers: |
C-10-502-004 |
| First Posted: | August 3, 2011 Key Record Dates |
| Last Update Posted: | October 25, 2019 |
| Last Verified: | April 2015 |
Additional relevant MeSH terms:
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Blepharitis Eyelid Diseases Eye Diseases Azithromycin Dexamethasone Dexamethasone acetate BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents Anti-Infective Agents |