Adherence Assessment With Travalert Dosing Aid

NCT00508469 | Completed Phase 4 Results

• 1 other identifier: EMD-06-03
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Open-angle Glaucoma; Ocular Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Adherence

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

  6 months

Study Arms (2)

Travalert with travoprost/timolol fixed combination

EXPERIMENTAL

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

Drug: Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav); Device: Travalert Dosing Aid

Travalert with travoprost and timolol

EXPERIMENTAL

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.

Drug: Travoprost 0.004% eye drops; Drug: Timolol 0.05% eye drops; Device: Travalert Dosing Aid

Interventions

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

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

Also known as: DuoTrav®

Travalert with travoprost/timolol fixed combination

Travoprost 0.004% eye drops DRUG

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

Travalert with travoprost and timolol

Timolol 0.05% eye drops DRUG

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

Travalert with travoprost and timolol

Travalert Dosing Aid DEVICE

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

Travalert with travoprost and timolol; Travalert with travoprost/timolol fixed combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Zaragoza

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Patient Compliance

Interventions

Travoprost; Timolol; Duotrav; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Severine Durier, PharmD
• Organization: Alcon France

+33 1 47 10 48 43

Study Officials

• Dr Francisco M. Honrubia

  Independent

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 30, 2007
• Study Start: October 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: July 12, 2012
• Results First Posted: July 12, 2012

Record last verified: 2012-06

Locations

ES (1)