Topical rVA576 for Treatment of Atopic Keratoconjunctivitis (NCT04037891) | Clinical Trial Compass
TerminatedPhase 1/2
Topical rVA576 for Treatment of Atopic Keratoconjunctivitis
Stopped: The trial has terminated early due to the disruptions caused by the ongoing COVID-19 pandemic. The decision was not related to any efficacy, safety or clinical concerns regarding rVA576.
Spain, United Kingdom12 participantsStarted 2019-03-04
Plain-language summary
Topical rVA576 for treatment of atopic keratoconjunctivitis (AKC), vernal keratoconjunctivitis (VKC),and severe allergic conjunctivitis (seasonal (SAC) or perennial (PAC)): a randomised placebo-controlled double masked parallel trial (TRACKER)
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged 18 and above
✓. Diagnosis of moderate to severe AKC, VKC, or severe allergic conjunctivitis (seasonal or perennial). Defined as:
✓. Will have had received some topical therapy during the last 3 months without improvement but will not currently be receiving systemic immunotherapy. Topical therapy may be topical calcineurin inhibitors, antihistamines or corticosteroids alone or in combination. Lubricants or artificial tears will not a count as topical therapy for these purposes.
✓. Will have had at least 7 days without topical ocular corticosteroids prior to entry
✓. Willing to give informed consent
✓. Willing to use highly effective contraceptive precautions for the duration of the study and for 90 days after the last dose of IMP
✓. Willing to avoid prohibited medications for duration of study (see list of prohibited medications)
Exclusion criteria
✕. Eye surface disease other than AKC, VKC or severe allergic conjunctivitis (SAC or PAC)
✕. Complete or partial tarsorrhaphy. If such a procedure becomes necessary during the course of the trial patients may remain in the trial providing that at least 50% of the eye surface remains visible to slit lamp examination
✕. Ankyloblepharon of any degree at entry to the trial
✕. Known or suspected ocular malignancy
✕. Active ocular infection at entry to the trial. Patients with eye surface bacterial, viral, fungal or protozoal infection may enter the trial after elimination of the infection as confirmed by eye swabs
✕. Known or suspected uveitis
✕. Participation in any other clinical trial within 1 month of enrolment