Back to resultsEfficacy of Changing to TRAVATAN® From Prior Therapy
Primary Purpose
Open-Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Travoprost 0.004%
Sponsored by
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Glaucoma, OAG, OHT
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye.
- Be on either latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy (including BAK-containing generics) for at least four weeks prior to Screening visit.
- Would benefit from a switch to TRAVATAN® Solution without BAK containing Polyquad® Preservative due to tolerability issues, in the opinion of the investigator.
- IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that assured clinical stability of vision and the optic nerve throughout the study period.
- Willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
- Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study deemed clinically significant in the opinion of the Principal Investigator.
- Any abnormality preventing reliable applanation tonometry in either eye.
- Severe dry eye or related which has been or currently is being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
- Any clinically significant, serious, or severe medical condition.
- Intraocular conventional surgery or laser surgery in either eye less than three months prior to Screening Visit.
- Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
- Progressive retinal or optic nerve disease from any cause.
- Women who are pregnant, lactating.
- Women not using reliable means of birth control.
- Use of any systemic medication known to affect IOP which has not been on stable course for at least 7 days prior to Screening Visit.
- Any clinically significant, serious, or severe medical condition.
- Participation in any other investigational study within 30 days of Screening Visit.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TRAVATAN® BAK-free
Arm Description
Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks
Outcomes
Primary Outcome Measures
Mean Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
Secondary Outcome Measures
Percentage of Patients With Target IOP (≤18 mmHg) at 12 Weeks
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01493427
Brief Title
Efficacy of Changing to TRAVATAN® From Prior Therapy
Official Title
Multi-Center Study Assessing the Efficacy and Tolerability of TRAVATAN® Solution Without BAK, Containing Polyquad® Preservative (0.004% Travoprost) in Patients Previously on Latanoprost 0.005% or Bimatoprost 0.01% Ophthalmic Solution Monotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (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 study was to assess the efficacy and tolerability of TRAVATAN® Solution without benzalkonium chloride (BAK) in patients previously on latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy.
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
Glaucoma, OAG, OHT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TRAVATAN® BAK-free
Arm Type
Experimental
Arm Description
Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Travoprost 0.004%
Other Intervention Name(s)
TRAVATAN® BAK-free
Intervention Description
Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative
Primary Outcome Measure Information:
Title
Mean Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)
Description
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Percentage of Patients With Target IOP (≤18 mmHg) at 12 Weeks
Description
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye.
Be on either latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy (including BAK-containing generics) for at least four weeks prior to Screening visit.
Would benefit from a switch to TRAVATAN® Solution without BAK containing Polyquad® Preservative due to tolerability issues, in the opinion of the investigator.
IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that assured clinical stability of vision and the optic nerve throughout the study period.
Willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study deemed clinically significant in the opinion of the Principal Investigator.
Any abnormality preventing reliable applanation tonometry in either eye.
Severe dry eye or related which has been or currently is being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
Any clinically significant, serious, or severe medical condition.
Intraocular conventional surgery or laser surgery in either eye less than three months prior to Screening Visit.
Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
Progressive retinal or optic nerve disease from any cause.
Women who are pregnant, lactating.
Women not using reliable means of birth control.
Use of any systemic medication known to affect IOP which has not been on stable course for at least 7 days prior to Screening Visit.
Any clinically significant, serious, or severe medical condition.
Participation in any other investigational study within 30 days of Screening Visit.
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Severine Durier, Pharm.D
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Changing to TRAVATAN® From Prior Therapy
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