GlaucomaPhase 1NCT01658839

Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients

A Phase 1 study testing Travoprost ophthalmic solution, 0.004% (new formulation) in people with Glaucoma and Ocular Hypertension, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to assess the safety and describe the steady-state plasma pharmacokinetic (PK) profiles of Travoprost ophthalmic solution, 0.004% (new formulation) following a once daily administration for 7 days in pediatric glaucoma or ocular hypertension patients. Read more about this study

Who is it for?: Ages 2 months to 17 years
Conditions the study is for: Glaucoma, Ocular Hypertension
What is being tested?: Travoprost ophthalmic solution, 0.004% (new formulation)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: No sites listed yet
Study dates: Jan 2013to Jul 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 months to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Diagnosis of glaucoma or ocular hypertension in at least 1 eye.
Parent/legal guardian must provide informed consent, and children must agree to sign an approved assent form when applicable.
Must agree to comply with the requirements of the study and must be accompanied by a parent/guardian.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Females of childbearing potential that are currently pregnant, have a positive result on a pregnancy test at the Screening Visit, intend to become pregnant during the study period, are breast feeding, or are not using birth control measures.
One sighted eye or monocular, including patients who cannot be dosed in both eyes for any reason.
History of chronic, recurrent or severe inflammatory eye disease.
Ocular trauma requiring medical attention within the past 3 months prior to the Screening Visit.
Ocular infection or ocular inflammation within the past 30 days prior to the Screening Visit.
Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.

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Other severe ocular pathology (including severe dry eye), that in the opinion of the Investigator, would preclude the administration of a topical prostaglandin analogue.
Intraocular surgery within the past 30 days prior to the Screening Visit.
Any abnormality preventing reliable tonometry.
Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
Hypersensitivity to prostaglandin analogues or to any component of the study medications in the opinion of the Investigator.
Therapy with another investigational agent or device within 30 days prior to the Screening Visit.
Body weight < 5kg.
Other protocol-defined exclusion criteria may apply.

About this study

Official title: An Open-Label, Pharmacokinetic and Safety Study of Travoprost Ophthalmic Solution, 0.004% in Pediatric Glaucoma or Ocular Hypertension Patients

Conditions: Glaucoma, Ocular Hypertension
Being tested: Travoprost ophthalmic solution, 0.004% (new formulation)
Keywords: pediatric glaucoma, pediatric ocular hypertension, travoprost
Medical subject headings: Glaucoma, Ocular Hypertension, Hydrophthalmos

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Travoprost ophthalmic solution, 0.004% (new formulation)Drug
Travoprost ophthalmic solution, 0.004%, new formulation

Study groups in NCT01658839
Study group	Role	What they receive
Travoprost	Experimental	Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days Receives: Drug: Travoprost ophthalmic solution, 0.004% (new formulation)

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax)
Travoprost free acid plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Cmax was calculated for each participant with at least 1 quantifiable time point.
Measured: Day 7, Up to 80 minutes postdose
Time to Reach Cmax (Tmax)
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Tmax was calculated for each participant with at least 1 quantifiable time point.
Measured: Day 7, Up to 80 minutes postdose
Time to Last Measurable Concentration (Tlast)
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Tlast was calculated for each participant with at least 1 quantifiable time point.
Measured: Day 7, Up to 80 minutes postdose
Area Under the Analyte Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point [AUC(0-tlast)]
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). AUC(0-tlast) was calculated for each participant with at least 2 quantifiable time points.
Measured: Day 7, Up to 80 minutes postdose
Area Under the Analyte Plasma Concentration-time Curve Over the Dosing Interval (Inf)[AUC(0-∞)]
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). AUC(0-∞) was calculated for each participant with at least 3 quantifiable time points.
Measured: Day 7, Up to 80 minutes postdose
Half-life (t½)
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). T½ was calculated for each participant with at least 3 quantifiable time points.
Measured: Day 7, Up to 80 minutes postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Jul 2013

First posted7 Aug 2012 (estimated)
Study startJan 2013
Primary completionJul 2013
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GlaucomaStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01658839
Sponsor's protocol ID: C-12-009
Other IDs: 2012-001640-22
Status last verified: Mar 2016
First submitted: 3 Aug 2012
Last updated: 1 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Pharmacokinetic and Safety Study of Travoprost Ophthalmic Solution, 0.004% in Pediatric Glaucoma or Ocular Hypertension Patients
ClinicalTrials.gov ID: NCT01658839
Acronym / sponsor ID: C-12-009
Conditions: Glaucoma, Ocular Hypertension
Keywords: pediatric glaucoma, pediatric ocular hypertension, travoprost
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jan 2013
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 7 Aug 2012 (estimated)
Results: Posted 21 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Travoprost	Experimental	Drug: Travoprost ophthalmic solution, 0.004% (new formulation)Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days

Who may qualify

Ages: 2 months to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Diagnosis of glaucoma or ocular hypertension in at least 1 eye.
Parent/legal guardian must provide informed consent, and children must agree to sign an approved assent form when applicable.
Must agree to comply with the requirements of the study and must be accompanied by a parent/guardian.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (14 listed)

Females of childbearing potential that are currently pregnant, have a positive result on a pregnancy test at the Screening Visit, intend to become pregnant during the study period, are breast feeding, or are not using birth control measures.
One sighted eye or monocular, including patients who cannot be dosed in both eyes for any reason.
History of chronic, recurrent or severe inflammatory eye disease.
Ocular trauma requiring medical attention within the past 3 months prior to the Screening Visit.
Ocular infection or ocular inflammation within the past 30 days prior to the Screening Visit.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Travoprost ophthalmic solution, 0.004% (new formulation)Travoprost ophthalmic solution, 0.004%, new formulation	Drug	Travoprost

Primary outcome

Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax)
Time frame: Day 7, Up to 80 minutes postdose
Travoprost free acid plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Cmax was calculated for each participant with at least 1 quantifiable time point.
Time to Reach Cmax (Tmax)
Time frame: Day 7, Up to 80 minutes postdose
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Tmax was calculated for each participant with at least 1 quantifiable time point.
Time to Last Measurable Concentration (Tlast)
Time frame: Day 7, Up to 80 minutes postdose
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Tlast was calculated for each participant with at least 1 quantifiable time point.
Area Under the Analyte Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point [AUC(0-tlast)]
Time frame: Day 7, Up to 80 minutes postdose
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). AUC(0-tlast) was calculated for each participant with at least 2 quantifiable time points.
Area Under the Analyte Plasma Concentration-time Curve Over the Dosing Interval (Inf)[AUC(0-∞)]
Time frame: Day 7, Up to 80 minutes postdose
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). AUC(0-∞) was calculated for each participant with at least 3 quantifiable time points.
Half-life (t½)
Time frame: Day 7, Up to 80 minutes postdose
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). T½ was calculated for each participant with at least 3 quantifiable time points.

Results and safety

Results posted to the registry on 21 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Travoprost	25	25

Primary outcome: Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax)

Time frame: Day 7, Up to 80 minutes postdose. Mean (Standard Deviation). Unit: ng/mL

Measure	Travoprost n = 11
Overall (n=11)	0.0256 (0.0158)
2 mo to < 3 years (n=2)	0.0471 (0.0105)
3 to <12 years (n=6)	0.0258 (0.0128)
12 to <18 years (n=3)	0.0109 (0.000046)

Population analysed: This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).

Primary outcome: Time to Reach Cmax (Tmax)

Time frame: Day 7, Up to 80 minutes postdose. Mean (Standard Deviation). Unit: hours

Measure	Travoprost n = 11
Overall (n=11)	0.25 (0.15)
2 mo to <3 years (n=2)	0.26 (0.11)
3 to <12 years (n=6)	0.17 (0.00)
12 to <18 years (n=3)	0.39 (0.26)

Primary outcome: Time to Last Measurable Concentration (Tlast)

Time frame: Day 7, Up to 80 minutes postdose. Mean (Standard Deviation). Unit: hours

Measure	Travoprost n = 11
Overall (n=11)	0.42 (0.35)
2 mo to <3 years (n=2)	0.34 (0.01)
3 to <12 years (n=6)	0.46 (0.47)
12 to <18 years (n=3)	0.39 (0.26)

Primary outcome: Area Under the Analyte Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point [AUC(0-tlast)]

Time frame: Day 7, Up to 80 minutes postdose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Travoprost n = 6
Overall (n=6)	0.0116 (0.0099)
2 mo to <3 years (n=2)	0.0101 (0.0014)
3 to <12 years (n=4)	0.0123 (0.0127)

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study (6 months). This analysis group includes all participants who received study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Travoprost	1 of 25 (4%)	0 of 25 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Subha Venkataraman study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Travoprost ophthalmic solution, 0.004% (new formulation) in people with Glaucoma and Ocular Hypertension, run by Alcon Research.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax) (time frame: Day 7, Up to 80 minutes postdose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01658839.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2016.