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

NCT00754949 | Withdrawn Phase 3

• 1 other identifier: C-07-502-003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Blepharoconjunctivitis

Keywords

Blepharoconjunctivitis,; Ophthalmology

Outcome Measures

Primary Outcomes (1)

• Resolution of the clinical signs and symptoms.

  2 weeks

Secondary Outcomes (1)

• Bacterial eradication

  2 weeks

Study Arms (3)

1

EXPERIMENTAL

Drug: 1% Azithromycin and 0.1% Dexamethasone

2

ACTIVE COMPARATOR

Drug: 1% Azithromycin

3

ACTIVE COMPARATOR

Drug: 0.1% Dexamethasone

Interventions

1% Azithromycin and 0.1% Dexamethasone DRUG

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

Also known as: AzaSite Plus

1

1% Azithromycin DRUG

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

Also known as: AzaSite

2

0.1% Dexamethasone DRUG

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

Also known as: Dexamethasone

3

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

MeSH Terms

Interventions

Azithromycin; Dexamethasone

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 16, 2008
• First Posted: September 18, 2008
• Last Updated: November 22, 2021

Record last verified: 2021-11