Viral ConjunctivitisPhase 2NCT01977443
Therapeutic Efficacy of APD-209 Eye Drops in Treatment of Epidemic Keratoconjunctivitis (EKC)
A Phase 2 study testing APD-209 Eye drops in people with Viral Conjunctivitis, run by Adenovir Pharma AB at 10 sites in 3 countries.
Trial summary
A randomized, double-masked, placebo-controlled, multi-centre phase IIa proof-of-concept study to evaluate efficacy and safety of APD-209 Eye drops for treatment of acute phase adenovirus-induced EKC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Viral Conjunctivitis
- What is being tested?
- APD-209 Eye drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Nov 2013to Sep 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients have to meet all of the following criteria to be eligible to enter the study:
- Willing and able to provide informed consent.
- Men or women aged 18 years or above with onset of adenoviral EKC symptoms in at least one eye, as clinically diagnosed and with symptoms appearing within less 7 days at the time of giving informed consent.
- Using adequate contraceptive measures
Who cannot join
- Known or suspected allergy to any ingredient of the IMP or placebo.
- Symptoms correlating with EKC since more than 7 days.
- Diagnosis of other significant disease(s) than EKC in the eye.
- Diagnosis of bacterial or fungal ocular infections.
- Use of antibiotics or corticosteroids by any route (except intravitreal corticosteroids) within 14 days prior to inclusion. Ocular antibiotics may, however, be used until 2 hours prior to first dose of IMP, but are thereafter prohibited during the study.
- Use of immunosuppressive medications (including intravitreal corticosteroids) within 6 months prior to inclusion.
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- Use of antiviral medications within 7 days prior to inclusion.
- Usage of any medication or herbal medicinal product with documented adverse reactions affecting the eyes.
- Usage of any medication or herbal medicinal product for ocular administration at inclusion.
- Female patients: currently pregnant or breast-feeding or intending to become pregnant during the study period.
- Known or suspected drug abuse.
- Usage of contact lenses during the study.
- Participation in any other interventional clinical study within 30 days prior to inclusion
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Germany7 sites
Augenklinik Universitätzmedizin Charité
Berlin, 12200
Augenklinik Köln, Merheim
Cologne, 51109
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Universitäts-Augenklinik Freiburg
Freiburg im Breisgau, 79106
Universitäts-klinikum Schleswig-Holstein
Lübeck, 23538
Augenklinik, Universitätsklinikum Tübingen
Tübingen, 72026
Universitäts-Augenklinik
Würzburg, 97080
Poland2 sites
Katowice University Hospital
Katowice, 40-514
P. Oleksy Centrum Medyczne Uno-Med
Tarnów, 33-100
About this study
Official title: Evaluation of the Therapeutic Efficacy of APD-209 Eye Drops in Treatment of Acute Phase Adenoviral-Induced Epidemic Keratoconjunctivitis (EKC). A Randomised, Double-Masked, Placebo-Controlled, Multi-Centre Proof-of-Concept Study
A randomized, double-masked, placebo-controlled, multi-centre phase IIa proof-of-concept study to evaluate efficacy and safety of APD-209 Eye drops for treatment of acute phase adenovirus-induced EKC. The aims of the study are to investigate the therapeutic efficacy of APD-209 Eye drops as measured by adenoviral load, time to viral eradication, clinical resolution of EKC (objective and subjective assessments), presence of opacities, visual acuity and frequency of second eye infections, and to assess the safety and tolerability of APD-209 Eye drops in EKC infected eyes.
- Conditions
- Viral Conjunctivitis
- Being tested
- APD-209 Eye drops, APD-209 Placebo Eye drops
- Medical subject headings
- Conjunctivitis, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APD-209 Eye dropsDrug
APD-209 Placebo Eye dropsDrug
| Study group | Role | What they receive |
|---|---|---|
| APD-209 Eye drops | Active comparator | APD-209 Eye drops Receives: Drug: APD-209 Eye drops |
| APD-209 Placebo Eye drops | Placebo comparator | APD-209 Placebo Eye drops Receives: Drug: APD-209 Placebo Eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to assess the adenoviral load in epidemic keratokonjunctivitis (EKC) infected eyes following topical treatment with APD-209 Eye drops compared to placebo.
Viral load in tear liquid from EKC infected eyes, as measured by the area under the curve (AUC) at 3-14 days from start of treatment.
Measured: 14 days
Secondary outcomes (6)
Assess the time to viral eradication in EKC infected eyes following treatment with APD-209 Eye drops compared to placebo.
The time point of viral eradication in tear liquid from EKC infected eyes, defined as the time Point when viral load=0 or below the lower limit of quantification (LLOQ).
Measured: 14 days
Evaluate the effect of APD-209 Eye drops on clinical resolution of EKC, as measured by objective and subjective assessment of scaled clinical symptoms, compared to placebo.
Resolution of acute ocular symptoms at each time of assessment, as measured by objective (Investigator-based) assessment of conjunctival discharge and redness.
Measured: 14 days
Evaluate the presence of opacities (quantitatively and qualitatively) following treatment with APD-209 Eye drops compared to placebo.
Presence and location of opacities at each time of assessment, as measured by slit lamp examination.
Measured: 14 days
Assess the visual acuity following treatment with APD-209 Eye drops compared to placebo.
Visual acuity at each time of assessment by use of the logarithm of the Minimum Angle of Resolution (LogMAR) chart.
Measured: 28 days
Assess the frequency of second eye infections.
Occurrence of second eye infection.
Measured: 14 days
Assess the safety and tolerability of APD-209 Eye drops.
Safety variables: adverse events (AEs) (nature and incidence), Physical examination, vital signs, laboratory safety assessments (haematology, clinical chemistry and urinalysis)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adenovir Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support
- Responsible party
- Sponsor
- Investigators
- Carl Gustaf Laurell, MD PhD, Principal investigator, St Eriks Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977443
- Sponsor's protocol ID
- 2012/ADE002
- Other IDs
- 2012-005694-31
- Status last verified
- Nov 2016
- First submitted
- 31 Oct 2013
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Therapeutic Efficacy of APD-209 Eye Drops in Treatment of Acute Phase Adenoviral-Induced Epidemic Keratoconjunctivitis (EKC). A Randomised, Double-Masked, Placebo-Controlled, Multi-Centre Proof-of-Concept Study
- ClinicalTrials.gov ID
- NCT01977443
- Acronym / sponsor ID
- 2012/ADE002
- Conditions
- Viral Conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Adenovir Pharma ABIndustry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support
- Study start
- Nov 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 Nov 2013 (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.
A randomized, double-masked, placebo-controlled, multi-centre phase IIa proof-of-concept study to evaluate efficacy and safety of APD-209 Eye drops for treatment of acute phase adenovirus-induced EKC. The aims of the study are to investigate the therapeutic efficacy of APD-209 Eye drops as measured by adenoviral load, time to viral eradication, clinical resolution of EKC (objective and subjective assessments), presence of opacities, visual acuity and frequency of second eye infections, and to assess the safety and tolerability of APD-209 Eye drops in EKC infected eyes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APD-209 Eye drops | Active comparator | Drug: APD-209 Eye dropsAPD-209 Eye drops |
| APD-209 Placebo Eye drops | Placebo comparator | Drug: APD-209 Placebo Eye dropsAPD-209 Placebo Eye drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patients have to meet all of the following criteria to be eligible to enter the study:
- Willing and able to provide informed consent.
- Men or women aged 18 years or above with onset of adenoviral EKC symptoms in at least one eye, as clinically diagnosed and with symptoms appearing within less 7 days at the time of giving informed consent.
- Using adequate contraceptive measures
Key exclusion criteria (13 listed)
- Known or suspected allergy to any ingredient of the IMP or placebo.
- Symptoms correlating with EKC since more than 7 days.
- Diagnosis of other significant disease(s) than EKC in the eye.
- Diagnosis of bacterial or fungal ocular infections.
- Use of antibiotics or corticosteroids by any route (except intravitreal corticosteroids) within 14 days prior to inclusion. Ocular antibiotics may, however, be used until 2 hours prior to first dose of IMP, but are thereafter prohibited 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 |
|---|---|---|
| APD-209 Eye drops | Drug | APD-209 Eye drops |
| APD-209 Placebo Eye drops | Drug | APD-209 Placebo Eye drops |
Primary outcome
The primary objective is to assess the adenoviral load in epidemic keratokonjunctivitis (EKC) infected eyes following topical treatment with APD-209 Eye drops compared to placebo.
Time frame: 14 days
Viral load in tear liquid from EKC infected eyes, as measured by the area under the curve (AUC) at 3-14 days from start of treatment.
6 secondary outcomes
Assess the time to viral eradication in EKC infected eyes following treatment with APD-209 Eye drops compared to placebo.
Time frame: 14 days
Evaluate the effect of APD-209 Eye drops on clinical resolution of EKC, as measured by objective and subjective assessment of scaled clinical symptoms, compared to placebo.
Time frame: 14 days
Evaluate the presence of opacities (quantitatively and qualitatively) following treatment with APD-209 Eye drops compared to placebo.
Time frame: 14 days
Assess the visual acuity following treatment with APD-209 Eye drops compared to placebo.
Time frame: 28 days
Assess the frequency of second eye infections.
Time frame: 14 days
Assess the safety and tolerability of APD-209 Eye drops.
Time frame: 14 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 2 Nov 2016.
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.
Carl Gustaf Laurell, MD PhD principal investigator
St Eriks Eye Hospital
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APD-209 Eye drops in people with Viral Conjunctivitis, run by Adenovir Pharma AB at 10 sites in 3 countries.
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 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: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Poland, Sweden. 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?
The primary objective is to assess the adenoviral load in epidemic keratokonjunctivitis (EKC) infected eyes following topical treatment with APD-209 Eye drops compared to placebo. (time frame: 14 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 2 Nov 2016.