Oftac Eye Drops (0.05% Tacrolimus Ophthalmic Emulsion) for the Treatment of Active Non-infectious Anterior Uveitis

Who can take part

• Able and willing to provide written informed consent
• Able and willing to follow all study instructions, restrictions and attend study visits
• Male and female patients 18 to 70 years of age
• Patient has one of the following:; 4.1 A history of unilateral or bilateral ongoing (>/= 2 months) non-infectious anterior uveitis with chronic cellular infiltrate of +1 to +2 cells that has responded to steroids 4.2 A well-defined history of at least one episodes of acute anterior uveitis that responded to topical steroids and is currently with +1 to +2 cells, including patients that are on systemic stable therapy (oral immunosuppressive or injectable anti-TNF alpha inhibitors)
• BCVA equal or better than 0.3 Log MAR in the non-investigated eye

Who cannot take part

• Have known contraindications or a sensitivity to any of the study drugs or excipients
• Plan to have any form of eye surgery within the study period or less than 3 months prior to screening
• Have IOP < 6 millimeters of mercury (mmHg) or > 20 mmHg while being treated with more than two anti-glaucoma medications in the investigated eye on maximal antiglaucoma therapy
• Patient is using a cytochrome P450-3A4 inhibitor inducer (such as but not limited to rifampin, carbamazepine, St. John's Wort, etc)
• Have an active ocular infection (bacterial, viral, or fungal)
• Have active non-uveitic ocular inflammation (e.g., severe blepharitis, any active allergic conjunctivitis, peripheral ulcerative keratitis or scleritis) in either eye
• Have a known history or diagnosis of ocular herpes-simplex infection
• Have a history of old posterior uveitis, or scars or intermediate uveitis that was active during the last six months
• Have clinically significant abnormal ophthalmic findings (e.g. central corneal scar, advanced guttata) or a known history of a clinically significant eye disease in either eye that may interfere with the study examinations and/or put the patient in any risk according to the Investigator's judgment
• Have a condition or a situation that in the Investigator's opinion may put the subject at increased risk, confound study data or interfere significantly with the subject's study participation, including but not limited to unstable cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic or psychiatric disease
• Patient is using cyclosporine or tacrolimus for any condition and via any route of administration
• Be a female of childbearing potential who is currently pregnant, nursing, or planning to become pregnant or nurse during the study
• Have active posterior-uveitis and/or active intermediate uveitis or any other form of active uveitis aside from anterior uveitis
• Have chronic Anterior Chamber (AC) flare >/= +3
• Have high myopia (above 9 diopters) or astigmatism (above 4 diopters) in the study eye