NCT01426113

Brief Summary

The purpose of this study is to assess the safety and efficacy of a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2011

Typical duration for phase_3

Geographic Reach
7 countries

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1 year until next milestone

Results Posted

Study results publicly available

October 2, 2015

Completed
Last Updated

October 2, 2015

Status Verified

September 1, 2015

Enrollment Period

3.1 years

First QC Date

August 29, 2011

Results QC Date

June 29, 2015

Last Update Submit

September 2, 2015

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Intraocular Pressure (IOP) in the Study Eye

    IOP is a measure of the fluid pressure inside the study eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive change from baseline indicates an increase in IOP (worsening). Due to lack of enrollment, analysis was not performed for this outcome measure.

    Baseline, Week 6

Study Arms (2)

bimatoprost ophthalmic solution formulation A and vehicle

EXPERIMENTAL

1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.

Drug: bimatoprost ophthalmic solution formulation ADrug: bimatoprost vehicle

timolol ophthalmic solution

ACTIVE COMPARATOR

1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.

Drug: timolol ophthalmic solution

Interventions

bimatoprost ophthalmic solution formulation ADRUG

1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning for 6 weeks.

bimatoprost ophthalmic solution formulation A and vehicle
timolol ophthalmic solutionDRUG

1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.

timolol ophthalmic solution
bimatoprost vehicleDRUG

1 drop of bimatoprost vehicle in the affected eye(s) in the morning for 6 weeks, followed by 1 drop of bimatoprost vehicle in the affected eye(s) in the evening for 6 weeks.

bimatoprost ophthalmic solution formulation A and vehicle

Eligibility Criteria

Age2 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of congenital, juvenile glaucoma
  • Requires treatment with IOP-lowering medication in one or both eyes

You may not qualify if:

  • Surgical intervention is indicated or planned to lower IOP
  • Abnormally low body weight (below 5th percentile)
  • Any active eye infection or disease
  • Anticipated use of contact lenses during the study
  • Topical ocular steroid use within 2 months
  • History of ocular trauma in either eye
  • Required chronic use of ocular medications (other than study medication) during the study (intermittent use of artificial tears permitted)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Louisville, Kentucky, United States

Location

Unknown Facility

Amiens, France

Location

Unknown Facility

Milan, Italy

Location

Unknown Facility

Parma, Italy

Location

Unknown Facility

City of Taguig, Philippines

Location

Unknown Facility

Makati, Philippines

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

London, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

AmidesOrganic ChemicalsCloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Results Point of Contact

Title
Therapeutic Area Head,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2011

First Posted

August 31, 2011

Study Start

September 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 2, 2015

Results First Posted

October 2, 2015

Record last verified: 2015-09

Locations

US(1)FR(1)TW(1)GB(1)PH(2)KR(1)IT(2)