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

NCT02102750 | Completed Phase 1 DMC

• 2 other identifiers: 2013502013-004302-26
• Study Type: interventional
• Target: 17
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of the study is to examine how preservative free tafluprost ophthalmic solution (0.0015%) is distributed in blood circulation after ocular administration in children who have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general will also be assessed.

Conditions

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of tafluprost acid.

  8 days +/- 1 day window

Study Arms (1)

tafluprost

EXPERIMENTAL

Drug: Preservative free tafluprost opthalmic solution

Interventions

Preservative free tafluprost opthalmic solution DRUG

0.0015% eye drops q.d, in both eyes for 7 to 9 days

tafluprost

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient is a non-smoking male or female ≤ 17 years of age on the day of signing the informed consent. Infants must be at least 1 month of age
• A diagnosis of primary or secondary pediatric glaucoma or ocular hypertension in one or both eyes
• A history of IOP greater than or equal to 22 mmHg in at least one eye. Newly diagnosed patients may have this criterion fulfilled at the pre-study visit.
• Patient is currently prescribed ocular hypotensive medication and who according to investigator'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 hypotensive medication).
• Female patients of reproductive potential must demonstrate a negative pregnancy test at the pre-study visit
• Patient is judged to be in good health, other than having glaucoma or ocular hypertension, based on medical history, physical examination, vital signs measurements, and laboratory safety tests performed at the pre-study visit and/or prior to administration of the initial dose of study drug
• Patient has no clinically significant abnormality on electrocardiogram (ECG) performed at 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 as applicable.
• The patient and parent/guardian should agree to comply with study restrictions, treatment plan, procedures and keep scheduled clinic visits.

You may not qualify if:

• Patient currently wears continuous wear contact lenses (use of daily wear contact lenses during the study is permitted)
• One-sighted or monocular patients, including patients who cannot be dosed in both eyes for any reason
• History of goniotomy or trabeculotomy within 1 month of pre-study visit or history of cataract surgery, laser surgery, filtration surgery, implant surgery or cyclodestructive 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 of prestudy visit
• Patient has a history or evidence of recent ocular inflammation and/or infection within 1 month of pre-study visit
• Patient has chronic conjunctivitis, chronic keratitis or lacrimal deficiency
• Patient is pregnant, breastfeeding, expecting to conceive within the projected duration of the study
• Patient has had major (non-ocular) surgery, loss of \> 5 cc/kg of blood within 4 weeks of 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, or known 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 anaphylactic reaction 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 patient in the study
• Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days from the pre-study visit

Sponsors & Collaborators

• Santen Oy: lead

Study Sites (2)

Childrens Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, 19104, United States

Location

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Auli Ropo

  Santen Oy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 3, 2014
• Study Start: June 1, 2014
• Primary Completion: May 29, 2017
• Study Completion: July 3, 2017
• Last Updated: October 10, 2017

Record last verified: 2017-10

Locations

US (1); GB (1)