Summary
EudraCT Number:2004-002887-41
Sponsor's Protocol Code Number:OV-W05
National Competent Authority:Germany - BfArM
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2004-11-29
Trial results
A. Protocol Information
A.1Member State ConcernedGermany - BfArM
A.2EudraCT number2004-002887-41
A.3Full title of the trial
Randomisierte, kontrollierte, für den Prüfer verblindete klinische Prüfung (Pilotstudie) zur Untersuchung der Wirksamkeit von Spersadex® Augentropfen im Vergleich zu Isopto®-Dex Augentropfen bei Patienten mit nicht-infektiöser Conjunctivitis
A.3.2Name or abbreviated title of the trial where available
Spersadex®-Wirksamkeitsstudie
A.4.1Sponsor's protocol code numberOV-W05
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorOmniVision GmbH
B.1.3.4CountryGermany
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.1.1.1Trade name Spersadex® Augentropfen
D.2.1.1.2Name of the Marketing Authorisation holderOmniVision GmbH/Mitvertrieb: Novartis Pharma GmbH
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameSpersadex® Augentropfen
D.3.4Pharmaceutical form Eye drops*
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPOcular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1CAS number 2392-39-4
D.3.9.3Other descriptive nameDexamethason-dihydrogenphosphat-Dinatrium
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.3Concentration number1,0
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.1.1.1Trade name Isopto® Dex
D.2.1.1.2Name of the Marketing Authorisation holderAlcon Pharma GmbH
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameIsopto® Dex
D.3.4Pharmaceutical form Eye drops, suspension
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPOcular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1CAS number 0000050-02-2
D.3.9.3Other descriptive nameDexamethason
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.3Concentration number1,0
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product Information not present in EudraCT
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Nicht-infektiöse Conjunctivitis
MedDRA Classification
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
Hauptzielparameter für die konfirmatorische Analyse ist die intraindividuelle pro Auge des Patienten ermittelte Veränderung der Summe der Grade der subjektiven Symptome (Tränen, Verkleben, Fremdkörpergefühl, Juckreiz und Brennen, jeweils mit den Ausprägungen „nicht vorhanden“=0, „gering ausgeprägt“=1, „mäßig ausgeprägt“=2 bzw. „stark ausgeprägt“=3) zwischen Behandlungsbeginn und 7 Tage nach Therapiebeginn, bzw. 14 Tage nach Therapiebeginn. Der Vergleich erfolgt intraindividuell bezüglich des Hauptzielkriteriums zwischen dem mit Spersadex® und dem mit Isopto®-Dex beträufelten Auge.
E.2.2Secondary objectives of the trial
Verschwinden der objektiven klinischen Befunde (Rötung der Bindehaut, Schwellung der Bindehaut, Sekretion der Bindehaut, Rötung des Augenlids, Schwellung des Augenlids), Auftreten von unerwünschten Ereignissen, die nicht ‚drug-related’ sind, Erhebung des ophthalmologischen Status zu Studienbeginn und bei der Abschlußuntersuchung [Visus- und Tensiobestimmung, Vorder- und Hinterabschnittsuntersuchung sowie Hornhautanfärbbarkeit (Schirmer-Test und Break-up-time)].
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
- Alter: 18 - 65 Jahre.// - Akute nicht-infektiöse Conjunctivitis an beiden Augen mit einer Gesamtsumme der fünf objektiven Befunde (Rötung der Bindehaut, Schwellung der Bindehaut, Sekretion der Bindehaut, Rötung des Augenlids, Schwellung des Augenlids) von mindestens fünf Punkten an jedem Auge, wobei jeder der Befunde einen Wert von 0-3 einnehmen kann.//- Schriftliche Einverständniserklärung zur freiwilligen Teilnahme an der Studie.

E.4Principal exclusion criteria
- Bekannte Überempfindlichkeit gegen einen der Inhaltsstoffe der Prüfmedikation.//- Verletzungen und ulzeröse Prozesse der Cornea, insbesondere durch Viren oder Bakterien verursachte Erkrankungen wie auch Augentuberkulose.//- Glaukom, Katarakt.//- Herpes corneae.//- Pilzinfektionen am Auge.//- Gleichzeitige lokale medikamentöse Therapie am Auge.//- Therapie mit lokal oder systemisch angewandten steroidhaltigen oder anderen entzündungshemmenden Arzneimitteln.//- Schwere systemische Begleiterkrankungen.//- Bei Frauen: Unzureichender Konzeptionsschutz. // - Bei Frauen: Schwangerschaft oder Stillzeit.//- Anamnestischer und/oder aktueller Alkohol- und/oder Drogenabusus.//- Psychische oder emotionale Labilität, wodurch die Einwilligung ungültig werden kann oder die Gefahr der nicht ordnungsgemäßen Durchführung der Studie besteht.//- Unzuverlässigkeit und/oder mangelnde Kooperationsbereitschaft.//- Teilnahme an einer anderen klinischen Studie innerhalb der letzten vier Wochen vor und/oder gleichzeitig zur Durchführung dieser Studie.
E.5 End points
E.5.1Primary end point(s)
Symptomfreiheit wurde als primärer Endpunkt definiert.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety No
E.6.5Efficacy Yes
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans Information not present in EudraCT
E.7.1.2Bioequivalence study Information not present in EudraCT
E.7.1.3Other Information not present in EudraCT
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind Yes
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other Yes
E.8.1.7.1Other trial design description
Intraindividueller Halbseitenvergleich (rechtes versus linkes Auge)
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Yes
E.8.2.2Placebo No
E.8.2.3Other No
E.8.3 The trial involves single site in the Member State concerned Yes
E.8.4 The trial involves multiple sites in the Member State concerned No
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial has a data monitoring committee Information not present in EudraCT
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
Die Studie gilt als beendet, wenn die letzte Untersuchung des letzten Patienten stattgefunden hat.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years
E.8.9.1In the Member State concerned months2
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial months2
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2004-11-29. Yes
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state30
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
Falls noch erforderlich, standardtherapeutische Weiterbehandlung durch einen Augenarzt.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2004-11-30
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2004-12-01
P. End of Trial
P.End of Trial StatusCompleted