BlepharoconjunctivitisPhase 3NCT00754949
Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis
A Phase 3 study testing 1% Azithromycin and 0.1% Dexamethasone, 1% Azithromycin and 0.1% Dexamethasone in people with Blepharoconjunctivitis, run by Sun Pharmaceutical Industries Limited.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Blepharoconjunctivitis
- What is being tested?
- 1% Azithromycin and 0.1% Dexamethasone, 1% Azithromycin and 0.1% Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
About this study
Official title: 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
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
- Being tested
- 1% Azithromycin and 0.1% Dexamethasone, 1% Azithromycin, 0.1% Dexamethasone
- Keywords
- Blepharoconjunctivitis,, Ophthalmology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Azithromycin and 0.1% DexamethasoneDrug
Also called AzaSite Plus
Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
1% AzithromycinDrug
Also called AzaSite
Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
0.1% DexamethasoneDrug
Also called Dexamethasone
Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: 1% Azithromycin and 0.1% Dexamethasone |
| 2 | Active comparator | Not described Receives: Drug: 1% Azithromycin |
| 3 | Active comparator | Not described Receives: Drug: 0.1% Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of the clinical signs and symptoms.
Measured: 2 weeks
Secondary outcomes (1)
Bacterial eradication
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharoconjunctivitisStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754949
- Sponsor's protocol ID
- C-07-502-003
- Status last verified
- Nov 2021
- First submitted
- 16 Sep 2008
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00754949
- Acronym / sponsor ID
- C-07-502-003
- Conditions
- Blepharoconjunctivitis
- Keywords
- Blepharoconjunctivitis,, Ophthalmology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- First posted
- 18 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 1% Azithromycin and 0.1% Dexamethasone |
| 2 | Active comparator | Drug: 1% Azithromycin |
| 3 | Active comparator | Drug: 0.1% Dexamethasone |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1% Azithromycin and 0.1% DexamethasoneAlso: AzaSite PlusSubjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes. | Drug | 1 |
| 1% AzithromycinAlso: AzaSiteSubjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes. | Drug | 2 |
| 0.1% DexamethasoneAlso: DexamethasoneSubjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes. | Drug | 3 |
Primary outcome
Resolution of the clinical signs and symptoms.
Time frame: 2 weeks
1 secondary outcome
Bacterial eradication
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
Related trials for Blepharoconjunctivitis
RecruitingObservational study
Treatment of Ocular Surface Inflammations
Ocular Surface Allergy, Conjunctivitis, Allergic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 1% Azithromycin and 0.1% Dexamethasone, 1% Azithromycin and 0.1% Dexamethasone in people with Blepharoconjunctivitis, run by Sun Pharmaceutical Industries Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of the clinical signs and symptoms. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.