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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005694-31 | EudraCT Number |
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| Name | Class |
|---|---|
| TFS Trial Form Support | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APD-209 Eye drops | Active Comparator | APD-209 Eye drops |
|
| APD-209 Placebo Eye drops | Placebo Comparator | APD-209 Placebo Eye drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APD-209 Eye drops | Drug |
| ||
| APD-209 Placebo Eye drops |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
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Inclusion Criteria:
The patients have to meet all of the following criteria to be eligible to enter the study:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl Gustaf Laurell, MD PhD | St Eriks Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augenklinik Universitätzmedizin Charité | Berlin | 12200 | Germany | |||
| Augenklinik Köln, Merheim |
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| ID | Term |
|---|---|
| D003236 | Conjunctivitis, Viral |
| ID | Term |
|---|---|
| D015828 | Eye Infections, Viral |
| D015817 | Eye Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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|
Resolution of acute ocular symptoms at each time of assessment, as measured by objective (Investigator-based) assessment of conjunctival discharge and redness. |
| 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. | 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. | 28 days |
| Assess the frequency of second eye infections. | Occurrence of second eye infection. | 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) | 14 days |
| Cologne |
| 51109 |
| Germany |
| Universitätsklinikum Düsseldorf | Düsseldorf | 40225 | Germany |
| Universitäts-Augenklinik Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Universitäts-klinikum Schleswig-Holstein | Lübeck | 23538 | Germany |
| Augenklinik, Universitätsklinikum Tübingen | Tübingen | 72026 | Germany |
| Universitäts-Augenklinik | Würzburg | 97080 | Germany |
| Katowice University Hospital | Katowice | 40-514 | Poland |
| P. Oleksy Centrum Medyczne Uno-Med | Tarnów | 33-100 | Poland |
| St Eriks Eye Hospital | Stockholm | Sweden |
| D003231 |
| Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |