Overview

Glaucoma Adherence Study, Spain

Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate adherence to DuoTrav® when reinforced by the use of the Travalert™ Dosing Aid.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alcon Research
Treatments:
Cloprostenol
Ophthalmic Solutions
Timolol
Travoprost
Criteria
Inclusion:

- Provide informed consent.

- Able to follow instructions and be willing and able to attend required study visits.

- Able to read and complete study questionnaires.

- Clinical diagnosis of ocular hypertension, or primary open-angle, pigment dispersion
or exfoliation glaucoma in at least one eye.

- Intraocular pressure considered safe, in both eyes, assuring clinical stability of
vision and the optic nerve throughout the trial.

- Currently treated with DuoTrav alone, dosed in the evening for at least for 30 days,
at Visit 1.

- Best corrected visual acuity of 20/200 Snellen or better in each eye.

- Intraocular pressure ≤ 30 mm Hg in both eyes.

- Evidence causing the investigator to consider the patient to be non-adherent, at some
level, to their glaucoma medication.

- Agree that their adherence could be improved by the intervention with the dosing aid
described in this study.

- Other protocol-defined inclusion criteria may apply.

Exclusion:

- Presence of other primary or secondary glaucoma not listed in inclusion criterion.

- Any abnormality preventing reliable applanation tonometry in the study eye(s).

- Any known opacity or patient uncooperativeness that restricts adequate examination of
the ocular fundus or anterior chamber of the study eye(s).

- Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either
eye.

- Intraocular conventional surgery or laser surgery in study eye(s) less than three
months prior to Visit 1.

- Risk of visual field or visual acuity worsening as a consequence of participation in
the trial, in the investigator's best judgment.

- Progressive retinal or optic nerve disease from any cause.

- Women of childbearing potential not using reliable means of birth control.

- Women who are pregnant or lactating.

- A condition, which in the opinion of the Principal Investigator, would interfere with
optimal participation in the study, or which would present a special risk to the
patient.

- Participation in any other investigational study within 30 days prior to Visit 1.

- Known medical history of allergy, sensitivity or poor tolerance to any components of
the preparations to be used in this trial that is deemed clinically significant in the
opinion of the Principal Investigator.

- Unwillingness to risk the possibility of darkened irides, eyelash changes or
periocular pigmentation.

- History of, or at risk for uveitis or cystoid macular edema (CME).

- Any physical disability which prevents the accurate use of the Travalert™ dosing aid.

- Unable to accurately instill the travoprost/timolol fixed combination in the evening.

- Other protocol-defined exclusion criteria may apply.