FindTrial
Sign In

Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis

A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical and Anti-Microbial Efficacy and Safety of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone in the Treatment of Subjects With Blepharoconjunctivitis

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00754949
Enrollment
0
Registered
2008-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blepharoconjunctivitis

Keywords

Blepharoconjunctivitis,, Ophthalmology

Brief summary

The purpose of this study is to determine if AzaSite Plus is effective and safe for the treatment of blepharoconjunctivitis compared to AzaSite alone and Dexamethasone alone.

Interventions

DRUG1% Azithromycin and 0.1% Dexamethasone

Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.

DRUG1% Azithromycin

Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.

DRUG0.1% Dexamethasone

Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.

Sponsors

Sun Pharmaceutical Industries Limited
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Have a clinical diagnosis of blepharoconjunctivitis * Must be willing to discontinue contact lens wear for the duration of the study * Have best corrected visual acuity of 6/24 in both eyes * Have IOP less than or equal to 25 mmHg in either eye

Exclusion criteria

* Have known sensitivity or poor tolerance to any component of the study medications * Have a history of eyelid and/or ocular surgery and/or have had ocular surgical intervention within 6 months prior to visit 1 or during the study and/or a history of refractive surgery within 6 months * Have worn contact lenses 72 hours prior to visit 1 and/or need to wear contact lenses for the duration of the study * Have used any topical ophthalmic solutions including tear substitutes within 2 hours of enrollment * Use of any eye make-up during the study * Have any uncontrolled systemic disease or debilitating disease * Have been diagnosed with glaucoma * Have any clinically significant cardiovascular disorders * Have any history of liver or kidney disease resulting in persisting dysfunction * Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device

Design outcomes

Primary

MeasureTime frame
Resolution of the clinical signs and symptoms.2 weeks

Secondary

MeasureTime frame
Bacterial eradication2 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026