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Therapeutic Efficacy of APD-209 Eye Drops in Treatment of Epidemic Keratoconjunctivitis (EKC)

Information source: Adenovir Pharma AB
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Viral Conjunctivitis

Intervention: APD-209 Eye drops (Drug); APD-209 Placebo Eye drops (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Adenovir Pharma AB

Official(s) and/or principal investigator(s):
Carl Gustaf Laurell, MD PhD, Principal Investigator, Affiliation: St Eriks Eye Hospital

Overall contact:
Björn Dellgren, M.Sc., Phone: +46 (0)42 38 74 28, Email: bjorn.dellgren@adenovir.com

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. 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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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.

Secondary outcome:

Assess the time to viral eradication in EKC infected eyes following treatment with APD-209 Eye drops compared to placebo.

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.

Evaluate the presence of opacities (quantitatively and qualitatively) following treatment with APD-209 Eye drops compared to placebo.

Assess the visual acuity following treatment with APD-209 Eye drops compared to placebo.

Assess the frequency of second eye infections.

Assess the safety and tolerability of APD-209 Eye drops.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 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 to 65 years (inclusive) with onset of adenoviral EKC symptoms in

at least one eye, as clinically diagnosed and with symptoms appearing within less than 72 hours at the time of giving informed consent.

- Using adequate contraceptive measures

Exclusion Criteria:

- Known or suspected allergy to any ingredient of the IMP or placebo.

- Symptoms correlating with EKC since more than 48 hours.

- 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.

- Use of immunosuppressive medications (including intravitreal corticosteroids) within

6 months prior to inclusion.

- 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

Locations and Contacts

Björn Dellgren, M.Sc., Phone: +46 (0)42 38 74 28, Email: bjorn.dellgren@adenovir.com

Augenklinik Universitätzmedizin Charité, Berlin 12200, Germany; Recruiting
Nicole Stübiger, Prof Dr

Universitätsklinikum Düsseldorf, Düsseldorf 40225, Germany; Recruiting
Gerd Geerling, Prof MD

Universitäts-Augenklinik Freiburg, Freiburg 79106, Germany; Recruiting
Chris Böhringer, Prof Dr

Augenklinik Köln, Merheim, Köln 51109, Germany; Recruiting
Stefan Christmann, Dr

Universitäts-klinikum Schleswig-Holstein, Lübeck 23538, Germany; Recruiting
Anne Brüggemann, Dr med

Augenklinik, Universitätsklinikum Tübingen, Tübingen 72026, Germany; Recruiting
Christoph Deuter, Dr. med

Universitäts-Augenklinik, Würzburg 97080, Germany; Recruiting
Daniel Kampik, Dr med

St Eriks Eye Hospital, Stockholm, Sweden; Recruiting
Carl Gustaf Laurell, MD PhD

Additional Information

Starting date: November 2013
Last updated: April 30, 2015

Page last updated: August 23, 2015

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