ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)
DrugAzithromycin and Dexamethasone twice daily for 2 weeks
Other names: AzaSite Plus
NCT Number: NCT01408082
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Arizona Eye Center, Chandler, Arizona, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Azithromycin and Dexamethasone twice daily for 2 weeks
Other names: AzaSite Plus
Azasite twice daily for 2 weeks
Dexamethasone twice daily for 2 weeks
Vehicle twice daily for 2 weeks
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.
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.
Sun Pharmaceutical Industries Limited
Industry
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
Acronym: DOUBle
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07451678
Blepharitis, Eye Diseases
Mexico City, Mexico
View Trial DetailsNCT05454956
Blepharitis, Demodex Infestation
Northridge, California, United States
View Trial DetailsNCT06795165
Blepharitis, Eye Diseases
Newport Beach, California, United States
View Trial DetailsNCT06520007
Blepharitis, Doxycycline Adverse Reaction
Milan, MI, Italy
View Trial Details