Conjunctivitis, ViralNCT01349452
Ganciclovir 0,15% Ophthalmic Gel in the Treatment of Adenovirus Keratoconjuntivitis
A study testing Ganciclovir and Artificial tear in people with Conjunctivitis, Viral and Adenoviridae Infections, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Ganciclovir ophthalmic gel delivers multiple advantages in the treatment and prophylaxis of herpetic keratitis and shows potential for effectiveness against other viral ocular infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conjunctivitis, Viral, Adenoviridae Infections
- What is being tested?
- Ganciclovir and Artificial tear
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2009to Jan 2010
- Phase
- Interventional
- 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
- onset of symptoms for five days or less
- eighteen years old or more
- not pregnant or breastfeeding
- be able to understand and sign the consent term
Who cannot join
- use of antibiotic or corticoid 30 days before
- monocular vision
- keratopathy or other ocular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Ganciclovir ophthalmic gel delivers multiple advantages in the treatment and prophylaxis of herpetic keratitis and shows potential for effectiveness against other viral ocular infections. The majority of adenoviral conjunctivitis will resolve without damaging vision, however, the investigators have no way to determine which cases will progress to ocular complications such as corneal infiltrates and pseudomembranes. Our purpose is to evaluate the efficacy of the Ganciclovir gel 0.15% in preventing ocular complications after adenoviral conjunctivitis.
- Conditions
- Conjunctivitis, Viral, Adenoviridae Infections
- Being tested
- Ganciclovir, Artificial tear
- Keywords
- Conjunctivitis, Viral, Adenoviridae Infections, Ganciclovir, Adenovirus Keratoconjunctivitis, Treatment of viral conjunctivitis
- Medical subject headings
- Conjunctivitis, Viral, Adenoviridae Infections, Multiple Acyl Coenzyme A Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanciclovirDrug
Ganciclovir 0.15% Ophthalmic gel
Artificial tearDrug
Artificial tear 5 times per day
| Study group | Role | What they receive |
|---|---|---|
| Ganciclovir | Experimental | Not described Receives: Drug: Ganciclovir |
| Artificial tear | Sham comparator | Not described Receives: Drug: Artificial tear |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of symptoms of conjunctivitis (pain relief)
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startAug 2009
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conjunctivitis, ViralStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Simone T Yabiku, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349452
- Sponsor's protocol ID
- GAN2011
- Status last verified
- Apr 2011
- First submitted
- 29 Apr 2011
- Last updated
- 6 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Yabiku ST, Yabiku MM, Bottos KM, Araujo AL, Freitas Dd, Belfort R Jr. [Ganciclovir 0.15% ophthalmic gel in the treatment of adenovirus keratoconjunctivitis]. Arq Bras Oftalmol. 2011 Nov-Dec;74(6):417-21. doi: 10.1590/s0004-27492011000600007. Portuguese.
PubMed 22331114
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ganciclovir 0,15% Ophthalmic Gel in the Treatment of Adenovirus Keratoconjuntivitis
- ClinicalTrials.gov ID
- NCT01349452
- Acronym / sponsor ID
- GAN2011
- Conditions
- Conjunctivitis, Viral, Adenoviridae Infections
- Keywords
- Conjunctivitis, Viral, Adenoviridae Infections, Ganciclovir, Adenovirus Keratoconjunctivitis, Treatment of viral conjunctivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 6 May 2011 (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.
Ganciclovir ophthalmic gel delivers multiple advantages in the treatment and prophylaxis of herpetic keratitis and shows potential for effectiveness against other viral ocular infections. The majority of adenoviral conjunctivitis will resolve without damaging vision, however, the investigators have no way to determine which cases will progress to ocular complications such as corneal infiltrates and pseudomembranes. Our purpose is to evaluate the efficacy of the Ganciclovir gel 0.15% in preventing ocular complications after adenoviral conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ganciclovir | Experimental | Drug: Ganciclovir |
| Artificial tear | Sham comparator | Drug: Artificial tear |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- onset of symptoms for five days or less
- eighteen years old or more
- not pregnant or breastfeeding
- be able to understand and sign the consent term
Key exclusion criteria (3 listed)
- use of antibiotic or corticoid 30 days before
- monocular vision
- keratopathy or other ocular diseases
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 |
|---|---|---|
| GanciclovirGanciclovir 0.15% Ophthalmic gel | Drug | Ganciclovir |
| Artificial tearArtificial tear 5 times per day | Drug | Artificial tear |
Primary outcome
improvement of symptoms of conjunctivitis (pain relief)
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2011.
- Derived from this study: PubMed 22331114Yabiku ST, Yabiku MM, Bottos KM, Araujo AL, Freitas Dd, Belfort R Jr. [Ganciclovir 0.15% ophthalmic gel in the treatment of adenovirus keratoconjunctivitis]. Arq Bras Oftalmol. 2011 Nov-Dec;74(6):417-21. doi: 10.1590/s0004-27492011000600007. Portuguese.
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.
Simone T Yabiku, MD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ganciclovir and Artificial tear in people with Conjunctivitis, Viral and Adenoviridae Infections, run by Federal University of São Paulo at 1 site in Brazil.
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: finished, as of the sponsor's last update on 6 May 2011. 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. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
improvement of symptoms of conjunctivitis (pain relief) (time frame: 6 days). 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 NCT01349452, which also lists 1 linked publication.
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 6 May 2011.