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Adherence Assessment With Travalert Dosing Aid

Primary Purpose

Open-angle Glaucoma, Ocular Hypertension

Status

Completed

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav)

Travoprost 0.004% eye drops

Timolol 0.05% eye drops

Travalert Dosing Aid

About this trial

This is an interventional treatment trial for Open-angle Glaucoma focused on measuring Intraocular pressure, Open-angle glaucoma, Ocular hypertension, Adherence, Compliance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of open-angle glaucoma or ocular hypertension;
Inadequate control with beta-blocker or prostaglandin monotherapy and starting therapy with travoprost 0.004% and timolol 0.05%;
Intraocular pressure (IOP) at the screening visit in at least one eye ≥ 19 mmHg but not exceeding 36 mmHg in either eye;
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Females of childbearing potential currently pregnant, breastfeeding, or not taking control measures to prevent pregnancy;
Not currently receiving treatment for lowering IOP with beta-blockers or prostaglandin analogs;
Currently on therapy or was in therapy with another investigational agent within 30 days prior to the baseline visit;
History of chronic or recurrent severe inflammatory eye disease, or history of ocular trauma within the past six (6) months, or history of ocular infection or ocular inflammation within the past three (3) months in either eye;
History of clinically significant or progressive retinal disease or history of any other severe ocular pathology in either eye that would preclude the administration of a topical prostaglandin analogue;
History of severe or serious hypersensitivity to prostaglandin drugs or their analogues, to topical or systemic beta-blockers, or to any components of the study medication;
Intraocular surgery within the past six (6) months or ocular laser surgery within the past three (3) months as determined by patient history and/or examination in either eye;
Any abnormality preventing reliable applanation tonometry of either eye;
Best-corrected visual acuity worse than 20/30 Snellen in either eye;
Use of any additional topical or systemic ocular hyposensitive medication during the study;
Other protocol-defined exclusion criteria may apply.

Sites / Locations

Zaragoza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Travalert with travoprost/timolol fixed combination

Travalert with travoprost and timolol

Arm Description

One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.

One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.

Outcomes

Primary Outcome Measures

Adherence

Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time.

Secondary Outcome Measures

Full Information

NCT ID

NCT00508469

First Posted

July 26, 2007

Last Updated

June 8, 2012

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT00508469

Brief Title

Adherence Assessment With Travalert Dosing Aid

Official Title

Adherence of Patients Using Travalert® for Instillation of a Fixed Combination of Travoprost 0.004%/Timolol 0.5% Compared to a Concomitant Regimen of Travoprost 0.004% and Timolol 0.5%

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to compare adherence in patients on a fixed combination of travoprost 0.004%/timolol 0.5% and patients on a concomitant combination of travoprost 0.004% and timolol 0.5% using the Travalert® device.

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

Intraocular pressure, Open-angle glaucoma, Ocular hypertension, Adherence, Compliance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Travalert with travoprost/timolol fixed combination

Arm Type

Experimental

Arm Description

One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.

Arm Title

Travalert with travoprost and timolol

Arm Type

Experimental

Arm Description

One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.

Intervention Type

Drug

Intervention Name(s)

Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav)

Other Intervention Name(s)

DuoTrav®

Intervention Description

One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.

Intervention Type

Drug

Intervention Name(s)

Travoprost 0.004% eye drops

Intervention Description

One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.

Intervention Type

Drug

Intervention Name(s)

Timolol 0.05% eye drops

Intervention Description

One drop in the study eye twice daily at 9 a.m. and 9 p.m. for six months using the Travalert device.

Intervention Type

Device

Intervention Name(s)

Travalert Dosing Aid

Intervention Description

Approved device used with study medication to record time of instillation and quantify dosing

Primary Outcome Measure Information:

Title

Adherence

Description

Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of open-angle glaucoma or ocular hypertension; Inadequate control with beta-blocker or prostaglandin monotherapy and starting therapy with travoprost 0.004% and timolol 0.05%; Intraocular pressure (IOP) at the screening visit in at least one eye ≥ 19 mmHg but not exceeding 36 mmHg in either eye; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Females of childbearing potential currently pregnant, breastfeeding, or not taking control measures to prevent pregnancy; Not currently receiving treatment for lowering IOP with beta-blockers or prostaglandin analogs; Currently on therapy or was in therapy with another investigational agent within 30 days prior to the baseline visit; History of chronic or recurrent severe inflammatory eye disease, or history of ocular trauma within the past six (6) months, or history of ocular infection or ocular inflammation within the past three (3) months in either eye; History of clinically significant or progressive retinal disease or history of any other severe ocular pathology in either eye that would preclude the administration of a topical prostaglandin analogue; History of severe or serious hypersensitivity to prostaglandin drugs or their analogues, to topical or systemic beta-blockers, or to any components of the study medication; Intraocular surgery within the past six (6) months or ocular laser surgery within the past three (3) months as determined by patient history and/or examination in either eye; Any abnormality preventing reliable applanation tonometry of either eye; Best-corrected visual acuity worse than 20/30 Snellen in either eye; Use of any additional topical or systemic ocular hyposensitive medication during the study; Other protocol-defined exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr Francisco M. Honrubia

Organizational Affiliation

Independent

Official's Role

Study Director

Facility Information:

Facility Name

Zaragoza

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

12. IPD Sharing Statement

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Adherence Assessment With Travalert Dosing Aid

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