Back to resultsTravacom Post Marketing Surveillance Study
Primary Purpose
Open-angle Glaucoma, Ocular Hypertension
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Travoprost/timolol fixed combination (Travacom)
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma focused on measuring OAG, OHT
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Travacom
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01510132
Brief Title
Travacom Post Marketing Surveillance Study
Official Title
Post Marketing Surveillance Study to Evaluate the Safety Profile of Travacom (Travoprost/Timolol Fixed Combination) in Patients With Open-Angle Glaucoma or Ocular Hypertension Across India
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Withdrawn
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this multi-center, open label, single arm, post-marketing surveillance study is to assess the safety of Travacom in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins, or other intraocular pressure-lowering (IOP) medication and when use of Travacom is considered appropriate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma, Ocular Hypertension
Keywords
OAG, OHT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Travacom
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Travoprost/timolol fixed combination (Travacom)
Other Intervention Name(s)
Travacom
Intervention Description
Commercially-marketed drug for the treatment of open-angle glaucoma or ocular hypertension
Primary Outcome Measure Information:
Title
Extent of exposure
Description
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.
Time Frame
Up to 8 weeks
Title
Adverse events
Description
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.
Time Frame
Up to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
Travacom Post Marketing Surveillance Study
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