ConjunctivitisPhase 3NCT01600365
Evaluate the Use of Ganciclovir Gel 0.3% for the Treatment of Conjunctivitis Caused by Adenovirus
A Phase 3 study testing Ganciclovir in people with Conjunctivitis and Adenovirus., run by Adapt Produtos Oftalmológicos Ltda..
Trial summary
The purpose of this study is to study the use of ganciclovir gel 0.3% for treatment of conjunctivitis caused by adenovirus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Conjunctivitis, Adenovirus.
- What is being tested?
- Ganciclovir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Jun 2012
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with eye disease with a clinical diagnosis of adenovirus conjunctivitis.
- Patients of both gender aged over 18 years.
- Patients who are not pregnant or nursing.
- Patients able (legally and mentally) to understand and sign informed consent had been signed.
Who cannot join
- Patients who are in the presence of corticosteroids, either by topical ocular, periocular, intraocular or systemic, for less than 30 days of enrollment and who can not make a drug suspension.
- Patients with serious systemic diseases like AIDS, cancer, etc., which in the opinion of the investigator, may put the patient at risk.
- Patient with a single eye or vision in one eye.
Trial locations and contacts
No sites are listed yet.
Cristina Muccioli, MD contact
About this study
Official title: "Prospective, Interventional, Randomized, Double-masked With the Use of Ganciclovir Gel 0.3% for Treatment of Conjunctivitis Caused by Adenovirus."
The purpose of this study is to study the use of ganciclovir gel 0.3% for treatment of conjunctivitis caused by adenovirus.
Read the detailed description
To evaluate the efficacy and tolerability of ganciclovir ophthalmic gel for the treatment of conjunctivitis comparing to placebo (ophthalmic gel). Visual acuity test and slit lamp examination (biomicroscopy) will be performed at each visit to assess the signs/symptoms and the regression of the disease.
- Conditions
- Conjunctivitis, Adenovirus.
- Being tested
- Ophthalmic gel (placebo), Ganciclovir
- Keywords
- Conjunctivitis, adenovirus.
- Medical subject headings
- Conjunctivitis, Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmic gel (placebo)Drug
Also called artificial tears
Ophthalmic gel (placebo): applied in affected eye 4 times daily for 10 days
GanciclovirDrug
Also called ganciclovir gel
Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Ganciclovir | Active comparator | Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days Receives: Drug: Ganciclovir |
| Ophthalmic gel (placebo) | Placebo comparator | ophthalmic gel (placebo)in the study eye Receives: Drug: Ophthalmic gel (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to regression of the ocular symptomatology
Time to regression of ocular symptomatology compared to the baseline, as determined by clinical evaluation (biomicroscopy) performed on V1, V2 and V3, based on scale of absent, mild, moderate and severe.
Measured: 10 days
Secondary outcomes (4)
Development of sub-epithelial infiltrates
Development of sub-epithelial infiltrates,incidence for the study duration and severity at each follow-up visit (based on scale of absent, mild, moderate and severe)
Measured: 10 days
Degree of Bulbar conjunctival Injection
Degree of bulbar conjunctival injection at each follow-up visit, based on the scale of mild, moderate and severe
Measured: 10 days
Involvement of the second eye
Involvement of the second eye - incidence for the study duration and severity at each follow-up visit, as determined by the clinical evaluation (biomicroscopy)
Measured: 10 days
Patient Dairy - intensity of ocular pain
intensity of ocular pain selected by the patient on the "Patient Dairy" based on the visual analogue scale (VAS)on each follow-up visit (absent, mild, moderate, severe)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConjunctivitisStudies 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
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adapt Produtos Oftalmológicos Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rubens Belfort, PhD, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600365
- Sponsor's protocol ID
- ADA-GAN-02/10
- Status last verified
- May 2012
- First submitted
- 22 Mar 2011
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Prospective, Interventional, Randomized, Double-masked With the Use of Ganciclovir Gel 0.3% for Treatment of Conjunctivitis Caused by Adenovirus."
- ClinicalTrials.gov ID
- NCT01600365
- Acronym / sponsor ID
- ADA-GAN-02/10
- Conditions
- Conjunctivitis, Adenovirus.
- Keywords
- Conjunctivitis, adenovirus.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Adapt Produtos Oftalmológicos Ltda.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 17 May 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.
The purpose of this study is to study the use of ganciclovir gel 0.3% for treatment of conjunctivitis caused by adenovirus.
Detailed description
To evaluate the efficacy and tolerability of ganciclovir ophthalmic gel for the treatment of conjunctivitis comparing to placebo (ophthalmic gel). Visual acuity test and slit lamp examination (biomicroscopy) will be performed at each visit to assess the signs/symptoms and the regression of the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ganciclovir | Active comparator | Drug: GanciclovirOphthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days |
| Ophthalmic gel (placebo) | Placebo comparator | Drug: Ophthalmic gel (placebo)ophthalmic gel (placebo)in the study eye |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with eye disease with a clinical diagnosis of adenovirus conjunctivitis.
- Patients of both gender aged over 18 years.
- Patients who are not pregnant or nursing.
- Patients able (legally and mentally) to understand and sign informed consent had been signed.
Key exclusion criteria (3 listed)
- Patients who are in the presence of corticosteroids, either by topical ocular, periocular, intraocular or systemic, for less than 30 days of enrollment and who can not make a drug suspension.
- Patients with serious systemic diseases like AIDS, cancer, etc., which in the opinion of the investigator, may put the patient at risk.
- Patient with a single eye or vision in one eye.
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 |
|---|---|---|
| Ophthalmic gel (placebo)Also: artificial tearsOphthalmic gel (placebo): applied in affected eye 4 times daily for 10 days | Drug | Ophthalmic gel (placebo) |
| GanciclovirAlso: ganciclovir gelOphthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days | Drug | Ganciclovir |
Primary outcome
time to regression of the ocular symptomatology
Time frame: 10 days
Time to regression of ocular symptomatology compared to the baseline, as determined by clinical evaluation (biomicroscopy) performed on V1, V2 and V3, based on scale of absent, mild, moderate and severe.
4 secondary outcomes
Development of sub-epithelial infiltrates
Time frame: 10 days
Degree of Bulbar conjunctival Injection
Time frame: 10 days
Involvement of the second eye
Time frame: 10 days
Patient Dairy - intensity of ocular pain
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2012.
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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.
Cristina Muccioli, MD contact
Rubens Belfort, PhD, MD principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ganciclovir in people with Conjunctivitis and Adenovirus., run by Adapt Produtos Oftalmológicos Ltda..
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 3 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: status not confirmed, as of the sponsor's last update on 17 May 2012. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rubens Belfort, PhD, MD (5511 55726443, rogeriomazon@adaptltda.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to regression of the ocular symptomatology (time frame: 10 days). 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 17 May 2012.