Travacom Post Marketing Surveillance Study | NCT01510132

NCT01510132

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Travacom	Experimental	Travoprost/timolol fixed combination self-administered at the rate of 1 drop per eye, one time a day, at approximately 8 a.m. each day for 8 weeks.	Drug: Travoprost/timolol fixed combination (Travacom)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Travoprost/timolol fixed combination (Travacom)	Drug	Commercially-marketed drug for the treatment of open-angle glaucoma or ocular hypertension	Travacom

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Extent of exposure	Extent of exposure is calculated as days on therapy. Days on therapy is defined as the difference in days between the date of exit (last) instillation as recorded on the last visit and the visit at which medication was first administered.	Up to 8 weeks
Adverse events	Any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. Adverse events will be collected spontaneously and systematically at each scheduled study visit and may be collected at any unscheduled visit that occurs during the study. Adverse events will be documented on Adverse Events Forms and will be reported by MedDRA preferred terminology.	Up to 8 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or older.
Open-angle glaucoma or ocular hypertension insufficiently responsive to betablockers, prostaglandins, or other intraocular pressure-lowering (IOP) agents and when the use of Travacom is considered appropriate.
Discontinued use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
Mean IOP not greater than 36 mmHG in either eye.
Read, sign, and date (or legal representative) the Informed Consent prior to the start of any study-related procedures.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Women of childbearing potential (not postmenopausal for at least one year or not surgically sterile) who are currently pregnant, have a positive result on the urine pregnancy test at Screening, intend to become pregnant during the study period, are breastfeeding, or do not agree to use an adequate birth control method to prevent pregnancy throughout the study.
Chronic, recurrent, or severe inflammatory eye disease, such as scleritis, uveitis, or herpes keratitis.
History of clinically significant or progressive retinal disease.
Best corrected visual acuity (BCVA) score worse than 20/80 Snellen.
Bronchial asthma or related history that would preclude safe administration of a topical beta-blocker.
Severe, unstable, or uncontrolled cardiovascular, hepatic, or renal disease or related history that would preclude safe administration of a topical beta-adrenergic blocking agent.
History of spontaneous or current hypoglycemia or uncontrolled diabetes.
Known medical allergy, hypersensitivity, or poor tolerance to any component of Travacom deemed clinically significant in the opinion of the Principal Investigator.
Use of any additional topical or system ocular hypotensive medication during the study.
Participation in any other investigational study within 30 days prior to Screening visit.
Other protocol-defined exclusion criteria may apply.

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension

ID	Term
D005901	Glaucoma
D005128	Eye Diseases