Tacrolimus Ophthalmic Solution for the Treatment of Non-infectious Anterior Uveitis
ConditionNon-infectious Anterior Uveitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovaliq GmbH
About this trial
The primary objective of the study is to investigate the safety and tolerability of NOV05 eye drops at two concentrations QID in patients with active non-infectious anterior uveitis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be ≥18 years of age;
Provide written informed consent;
Be diagnosed with active non-infectious anterior uveitis requiring initiation or increase of topical steroids administration for the management of ocular inflammation;
Have an onset of symptoms within 4 weeks;
Disqualifiers
Have severe/serious ocular pathology in the study eye which may preclude study completion or interferes with trial assessment, in the judgement of the clinical Investigator;
Have a history of or a current ocular or periocular malignancy;
Have active intermediate or posterior uveitis in the study eye or another documented posterior segment inflammation;
A confirmed or highly suspicious infectious uveitis eg, CMV, Herpes simplex, Herpes zoster, syphilis, tuberculosis, lyme disease;
Trial design
Design model
Parallel
Treatments tested in this trial
Tacrolimus ophthalmic solution
Drughigh and low dose treatment will be compared over 6 weeks treatment
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Tacrolimus ophthalmic solution (high dose)Active comparator 1 intervention
Group B: Tacrolimus ophthalmic solution (low dose)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adverse Events
ocular and non-ocular adverse events
Time frame
8 weeksSponsors and contacts
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Source ClinicalTrials.gov