A Study to Evaluate Pharmacokinetics of Tafluprost Ophthalmic Solution (0.0015%) in Pediatric Patients With Glaucoma or Ocular Hypertension

Inclusion Criteria:

• Patient is a non-smoking male or female ≤ 17 years of age on the day of signing theinformed consent. Infants must be at least 1 month of age

• A diagnosis of primary or secondary pediatric glaucoma or ocular hypertension in oneor both eyes

• A history of IOP greater than or equal to 22 mmHg in at least one eye. Newly diagnosedpatients may have this criterion fulfilled at the pre-study visit.

• Patient is currently prescribed ocular hypotensive medication and who according toinvestigator's judgement may discontinue the use at least day before the Day 1 visit,or patient is treatment-naïve (those who have never used used ocular hypotensivemedication).

• Female patients of reproductive potential must demonstrate a negative pregnancy testat the pre-study visit

• Patient is judged to be in good health, other than having glaucoma or ocularhypertension, based on medical history, physical examination, vital signsmeasurements, and laboratory safety tests performed at the pre-study visit and/orprior to administration of the initial dose of study drug

• Patient has no clinically significant abnormality on electrocardiogram (ECG) performedat the pre-study visit

• Parent/legal guardian and/or patient have/has provided a written informed consent (according to existing local regulations) and patient assent has been given asapplicable.

• The patient and parent/guardian should agree to comply with study restrictions,treatment plan, procedures and keep scheduled clinic visits.

Exclusion Criteria:

• Patient currently wears continuous wear contact lenses (use of daily wear contactlenses during the study is permitted)

• One-sighted or monocular patients, including patients who cannot be dosed in both eyesfor any reason

• History of goniotomy or trabeculotomy within 1 month of pre-study visit or history ofcataract surgery, laser surgery, filtration surgery, implant surgery orcyclodestructive surgery within 3 months prior to pre-study visit in one or both eyes.

• Patient has a history or evidence of significant ocular trauma within 3 months ofprestudy visit

• Patient has a history or evidence of recent ocular inflammation and/or infectionwithin 1 month of pre-study visit

• Patient has chronic conjunctivitis, chronic keratitis or lacrimal deficiency

• Patient is pregnant, breastfeeding, expecting to conceive within the projectedduration of the study

• Patient has had major (non-ocular) surgery, loss of > 5 cc/kg of blood within 4 weeksof the pre-study visit

• Any other ocular, systemic or psychiatric disease/condition or laboratory abnormality

• History of febrile illness within 5 days prior to start of study treatment

• Patient has a history of hypersensitivity to any component of tafluprost eye drops, orknown severe or serious hypersensitivity to any prostaglandin analogue product (e.g.latanoprost)

• Patient has a history of multiple and/or severe allergies or has had an anaphylacticreaction or significant intolerability to prescription or non-prescription (over-the-counter) drugs or food

• There is any concern by the investigator regarding the safe participation of a patientin the study

• Current participation in another clinical trial involving an investigationaldrug/device, or participation in such a trial within the last 30 days from thepre-study visit