Adherence Assessment With Travalert Dosing Aid
Condition: Open-angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
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
Intervention description: One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.; One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.; One drop in the study eye twice daily at 9 a.m. and 9 p.m. for six months using the Travalert device.; Approved device used with study medication to record time of instillation and quantify dosing
Intervention MeSH terms: Timolol; Travoprost; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Intraocular pressure; Open-angle glaucoma; Ocular hypertension; Adherence; Compliance

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.
    

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.