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

NCT ID: NCT00754949

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Blepharoconjunctivitis

Keywords

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Blepharoconjunctivitis, Ophthalmology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

1% Azithromycin and 0.1% Dexamethasone

Intervention Type DRUG

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

2

Group Type ACTIVE_COMPARATOR

1% Azithromycin

Intervention Type DRUG

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

3

Group Type ACTIVE_COMPARATOR

0.1% Dexamethasone

Intervention Type DRUG

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

Interventions

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1% 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.

Intervention Type DRUG

1% Azithromycin

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

Intervention Type DRUG

0.1% Dexamethasone

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

Intervention Type DRUG

Other Intervention Names

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AzaSite Plus AzaSite Dexamethasone

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Pharmaceutical Industries Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Insite Vision Inc.

Other Identifiers

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C-07-502-003

Identifier Type: -

Identifier Source: org_study_id