Acute Adenoviral KeratoconjunctivitisPhase 2NCT01156025
Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis
A Phase 2 study testing GV550 in people with Acute Adenoviral Keratoconjunctivitis, run by Laboratoires Thea at 1 site in France.
Trial summary
The study objective is to evaluate the efficacy and the safety of GV 550 in comparison to placebo in patients with acute adenoviral keratoconjuncivitis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Adenoviral Keratoconjunctivitis
- What is being tested?
- GV550
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Jun 2010
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Male or female aged from 18 to 80 years old
- Acute adenoviral keratoconjunctivitis
Who cannot join
- Active ocular allergy
- Ocular herpès disease
- History of bacterial conjunctivitis / blepharoconjunctivitis within the last month before the inclusion visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis (Phase II Pilot Study, Multicentre, International, Randomised, Double-masked, Placebo-controlled, 2x40 Patients)
The study objective is to evaluate the efficacy and the safety of GV 550 in comparison to placebo in patients with acute adenoviral keratoconjuncivitis.
- Conditions
- Acute Adenoviral Keratoconjunctivitis
- Being tested
- GV550, placebo
- Keywords
- GV550, Acute adenoviral keratoconjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GV550Drug
Ganciclovir 1.5 mg/g, 1 drop 10 times daily at D0 and D1 and 1 drop 5 times daily from D2 to D9 + additionnal treatment (Hyabak® eye drops: 5 times daily from D10 to D30)
placeboDrug
1 drop 10 times daily at D0 and D1 and 1 drop 5 times daily from D2 to D9 + additionnal treatment (Hyabak® eye drops: 5 times daily from D10 to D30)
| Study group | Role | What they receive |
|---|---|---|
| GV550 | Experimental | (Ganciclovir 1.5 mg/g ophtalmic gel) Receives: Drug: GV550 |
| Placebo | Placebo comparator | Placebo ophtalmic gel Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of GV550
- The evolution of the inflammation
- The virus load by quantitative PCR
Measured: D0 to D4
Secondary outcomes (3)
efficacy of GV550
- The assessment of the patient's symptomatology evaluation
- The score of each subjective signs
- The score of each objective signs
- The occurrence of focal corneal sub epithelial infiltrates (nummular stromal infiltration)
- The occurrence of pseudo membranes
- The virus load between D0-D10
Ocular safety
- To compare the ocular tolerance of GV550 eye drops versus placebo eye drops with respect of the assessment of the global local tolerance assessment by the investigator and by the patient
- To compare the ocular safety of GV550 eye drops versus placebo eye drops with respect of the assessment of the best corrected far visual acuity and ocular Adverse Event (AE) reporting at each visit
Systemic safety
- To compare the systemic safety of GV550 eye drops versus placebo eye drops with respect of the systemic AE reporting at each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startMar 2009
- Primary completionFeb 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Adenoviral KeratoconjunctivitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156025
- Sponsor's protocol ID
- LTGV550-PII-11/06
- Other IDs
- 2007-002455-16
- Status last verified
- Jul 2010
- First submitted
- 30 Jun 2010
- Last updated
- 2 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis (Phase II Pilot Study, Multicentre, International, Randomised, Double-masked, Placebo-controlled, 2x40 Patients)
- ClinicalTrials.gov ID
- NCT01156025
- Acronym / sponsor ID
- LTGV550-PII-11/06
- Conditions
- Acute Adenoviral Keratoconjunctivitis
- Keywords
- GV550, Acute adenoviral keratoconjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 2 Jul 2010 (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 study objective is to evaluate the efficacy and the safety of GV 550 in comparison to placebo in patients with acute adenoviral keratoconjuncivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GV550 | Experimental | Drug: GV550(Ganciclovir 1.5 mg/g ophtalmic gel) |
| Placebo | Placebo comparator | Drug: placeboPlacebo ophtalmic gel |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Male or female aged from 18 to 80 years old
- Acute adenoviral keratoconjunctivitis
Key exclusion criteria (3 listed)
- Active ocular allergy
- Ocular herpès disease
- History of bacterial conjunctivitis / blepharoconjunctivitis within the last month before the inclusion visit
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 |
|---|---|---|
| GV550Ganciclovir 1.5 mg/g, 1 drop 10 times daily at D0 and D1 and 1 drop 5 times daily from D2 to D9 + additionnal treatment (Hyabak® eye drops: 5 times daily from D10 to D30) | Drug | GV550 |
| placebo1 drop 10 times daily at D0 and D1 and 1 drop 5 times daily from D2 to D9 + additionnal treatment (Hyabak® eye drops: 5 times daily from D10 to D30) | Drug | Placebo |
Primary outcome
efficacy of GV550
Time frame: D0 to D4
* The evolution of the inflammation * The virus load by quantitative PCR
3 secondary outcomes
efficacy of GV550
Ocular safety
Systemic safety
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 2 Jul 2010.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GV550 in people with Acute Adenoviral Keratoconjunctivitis, run by Laboratoires Thea at 1 site in France.
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 3 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 2 Jul 2010. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
efficacy of GV550 (time frame: D0 to D4). 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 2 Jul 2010.