NCT01977443
Completed
Phase 2
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
ConditionsViral Conjunctivitis
Overview
- Phase
- Phase 2
- Intervention
- APD-209 Eye drops
- Conditions
- Viral Conjunctivitis
- Sponsor
- Adenovir Pharma AB
- Enrollment
- 47
- Locations
- 10
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility 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 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
Exclusion Criteria
- •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.
- •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.
Arms & Interventions
APD-209 Eye drops
APD-209 Eye drops
Intervention: APD-209 Eye drops
APD-209 Placebo Eye drops
APD-209 Placebo Eye drops
Intervention: APD-209 Placebo Eye drops
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Assess the frequency of second eye infections.(14 days)
- Assess the time to viral eradication in EKC infected eyes following treatment with APD-209 Eye drops compared to placebo.(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.(14 days)
- Evaluate the presence of opacities (quantitatively and qualitatively) following treatment with APD-209 Eye drops compared to placebo.(14 days)
- Assess the visual acuity following treatment with APD-209 Eye drops compared to placebo.(28 days)
- Assess the safety and tolerability of APD-209 Eye drops.(14 days)
Study Sites (10)
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Study comparing the efficacy of Eye drops containing the substance APD-209 and placebo for the treatment the a viral eye infection called Adenoviral-induced Epidemic Keratoconjunctivitis (EKC).Acute phase Adenoviral-induced Epidemic Keratoconjunctivitis, EKCMedDRA version: 14.1Level: LLTClassification code 10014975Term: Epidemic keratoconjunctivitisSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Eye Diseases [C11]EUCTR2012-005694-31-SEAdenovir Pharma AB130