Ocular InflammationPhase 3NCT01721694

Antibiotic Steroid Combination Compared With Individual Administration in the in the Treatment of Ocular Inflammation and Infection

A Phase 3 study testing azithromycin 1.5% + Loteprednol 0,5% (separately) in people with Ocular Inflammation and Infection Associated Blepharitis, run by Adapt Produtos Oftalmológicos Ltda. at 1 site in Brazil.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

To evaluate the efficacy and safety of fixed combination of azithromycin 1.5% + 0.5% Loteprednol eye drops for the treatment of ocular inflammation and infection associated bacterial blepharitis and / or keratitis and / or conjunctivitis compared with the individual administration of azithromycin 1.5% and 0.5%… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ocular Inflammation, Infection Associated Blepharitis, Keratitis
What is being tested?: azithromycin 1.5% + Loteprednol 0,5% (separately)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 1 siteBrazil
Study dates: Dec 2012to May 2013
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients were male or female, of any race and age minimum of 18 years.
Blepharitis should provide diagnostic and / or keratitis and / or conjunctivitis with or without bacterial involvement corneal by biomicroscopy, with positive staining corneal fluorescein and also provide a composite score ≥ 2 on: bulbar conjunctival hyperemia, eyelid conjunctiva, secretion / exudate conjunctival erythema and flaking eyelids / eyelid crust on at least one eye (the same eye) on Day 1 visit

Who cannot join

Intraocular hypertension or uncontrolled glaucoma.
Use of contact lenses during the study.
Capacity unilateral visual only.
Suspected fungal infection, viral (eg, herpes simplex epithelial, dendritic keratitis) or Acanthamoeba, or any other disease where the use of corticosteroids is contraindicated.
Use of any topical ophthalmic medications preserved during study participation. Not be allowed eyedrops preserved (eg artificial tears).
Use of any antibacterial agent oral or topical ophthalmic until 72 hours prior to study entry.

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Use of systemic steroids within 14 days prior to study entry. Ophthalmic topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs), until one week before admission to the study. Will not be allowed to use these medications during study participation. Will not be allowed to use nasal steroids during the study. Will be allowed to use inhaled steroids to aid inhaler. Will be allowed steroids dermal topics.
Use of nonsteroidal anti-inflammatory drugs (NSAIDs) systemic up to 24 hours prior to study entry or at any time during the study, unless the patient is under treatment regimen with stable (not necessary) for at least 2 months before Admission and therapy continues throughout the study.
Any disturbance or ocular or systemic disease, complicating factors or structural abnormality that affects the conduct or outcome of the study in a negative way or represents an undue risk to patient safety, according to the opinion of the investigator.
Any current immunosuppressive disorder (eg, HIV-positive), or immunosuppressive therapy (including chemotherapy).
Known allergy or suspected allergy or hypersensitivity to fluoroquinolones, to steroids or any other component of the study drug;
Pregnant or lactating. (Women of childbearing age may be admitted if they use contraception and submit urine pregnancy test negative);
Any patient who has a family member who participates in this study

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Department of Ophthalmology of Hospital São Paulo
São Paulo, São Paulo, 04023-062

Other trials in Brazil

About this study

Official title: Association of Azithromycin 1,5%/Loteprednol 0,5% Eye Drops Versus Individual Administration of Azithromycin 1,5% and Loteprednol 0,5% in the Treatment of Ocular Inflammation and Infection

Read the detailed description

Estimated to be admitted a total of approximately 60 patients showing blepharitis and / or keratitis and / or conjunctivitis: 30 patients will be assigned to the group of Azithromycin 1.5%/Loteprednol 0.5% Eye Drops (fixed combination) + placebo and 30 patients will be assigned to the group of Azithromycin 1.5% + 0.5% Loteprednol (separately)

Conditions: Ocular Inflammation, Infection Associated Blepharitis, Keratitis, Conjunctivitis, Bacterial
Being tested: azithromycin 1.5%/Loteprednol 0,5% + placebo, azithromycin 1.5% + Loteprednol 0,5% (separately)
Keywords: bacterial ocular inflammation, blepharitis, keratitis, conjunctivitis
Medical subject headings: Keratitis, Conjunctivitis, Bacterial, Blepharitis, Conjunctivitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

azithromycin 1.5%/Loteprednol 0,5% + placeboDrug
1 drop, AO, QID
azithromycin 1.5% + Loteprednol 0,5% (separately)Drug
Also called azithromycin 1.5% + Loteprednol 0,5% eye drops (separately)
1 drop, QID, AO

Study groups in NCT01721694
Study group	Role	What they receive
azithromycin 1.5%/Loteprednol 0,5% + placebo	Experimental	fixed combination of azithromycin 1.5% / Loteprednol 0,5% eye drops + placebo eye drops Receives: Drug: azithromycin 1.5%/Loteprednol 0,5% + placebo
azithromycin 1.5% + Loteprednol 0,5% (separately)	Active comparator	azithromycin 1.5% + Loteprednol 0,5% eye drops (separately) Receives: Drug: azithromycin 1.5% + Loteprednol 0,5% (separately)

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical cure
Clinical cure achieved when the score of the cardinal ocular signs (hyperemia in the bulbar conjunctiva, palpebral, exudate / conjunctival discharge, eyelid erythema and flaking / crust eyelid) is zero at the time of conclusion of the study (D8)
Measured: Day 8

Secondary outcomes (1)

irradication of pathogens
Success obtained with microbiological irradication of pathogens present at baseline
Measured: Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2012May 2013

First posted6 Nov 2012 (estimated)
Study startDec 2012
Primary completionMar 2013 (estimated)
Study completionMay 2013 (estimated)

Why it stopped: withdrawn by industry

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ocular InflammationStudies of the same condition, open and under way.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01721694
Sponsor's protocol ID: AZILOT-12
Other IDs: 131.835
Status last verified: Dec 2014
First submitted: 2 Nov 2012
Last updated: 11 Dec 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Association of Azithromycin 1,5%/Loteprednol 0,5% Eye Drops Versus Individual Administration of Azithromycin 1,5% and Loteprednol 0,5% in the Treatment of Ocular Inflammation and Infection
ClinicalTrials.gov ID: NCT01721694
Acronym / sponsor ID: AZILOT-12
Conditions: Ocular Inflammation, Infection Associated Blepharitis, Keratitis, Conjunctivitis, Bacterial
Keywords: bacterial ocular inflammation, blepharitis, keratitis, conjunctivitis
Phase: Phase 3
Study type: Interventional
Recruitment status: WithdrawnReason stopped: withdrawn by industry
Enrolment: 0 participants (actual)
Lead sponsor: Adapt Produtos Oftalmológicos Ltda.Industry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: Mar 2013 (estimated)
Study completion: May 2013 (estimated)
First posted: 6 Nov 2012 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
azithromycin 1.5%/Loteprednol 0,5% + placebo	Experimental	Drug: azithromycin 1.5%/Loteprednol 0,5% + placebofixed combination of azithromycin 1.5% / Loteprednol 0,5% eye drops + placebo eye drops
azithromycin 1.5% + Loteprednol 0,5% (separately)	Active comparator	Drug: azithromycin 1.5% + Loteprednol 0,5% (separately)azithromycin 1.5% + Loteprednol 0,5% eye drops (separately)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients were male or female, of any race and age minimum of 18 years.
Blepharitis should provide diagnostic and / or keratitis and / or conjunctivitis with or without bacterial involvement corneal by biomicroscopy, with positive staining corneal fluorescein and also provide a composite score ≥ 2 on: bulbar conjunctival hyperemia, eyelid conjunctiva, secretion / exudate conjunctival erythema and flaking eyelids / eyelid crust on at least one eye (the same eye) on Day 1 visit

Key exclusion criteria (13 listed)

Intraocular hypertension or uncontrolled glaucoma.
Use of contact lenses during the study.
Capacity unilateral visual only.
Suspected fungal infection, viral (eg, herpes simplex epithelial, dendritic keratitis) or Acanthamoeba, or any other disease where the use of corticosteroids is contraindicated.
Use of any topical ophthalmic medications preserved during study participation. Not be allowed eyedrops preserved (eg artificial tears).

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
azithromycin 1.5%/Loteprednol 0,5% + placebo1 drop, AO, QID	Drug	azithromycin 1.5%/Loteprednol 0,5% + placebo
azithromycin 1.5% + Loteprednol 0,5% (separately)Also: azithromycin 1.5% + Loteprednol 0,5% eye drops (separately)1 drop, QID, AO	Drug	azithromycin 1.5% + Loteprednol 0,5% (separately)

Primary outcome

Clinical cure
Time frame: Day 8
Clinical cure achieved when the score of the cardinal ocular signs (hyperemia in the bulbar conjunctiva, palpebral, exudate / conjunctival discharge, eyelid erythema and flaking / crust eyelid) is zero at the time of conclusion of the study (D8)

1 secondary outcome

irradication of pathogens
Time frame: Day 8

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 11 Dec 2014.

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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.

Rubens Belfort Jr., MD principal investigator

Federal University of São Paulo / Hospital São Paulo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 13 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 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Clinical cure (time frame: Day 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01721694.

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 11 Dec 2014.