A Twelve-Month Open-Label Safety Study of Polyquaternium-Preserved DuoTrav APSDosed Once Daily in Patients with Open-Angle Glaucoma or Ocular Hypertension - Safety Study of DuoTrav APS

Conditions: Open-Angle Glaucoma or Ocular Hypertension
MedDRA version: 12.0Level: LLTClassification code 10030043Term: Ocular hypertension
MedDRA version: 12.0Level: LLTClassification code 10030348Term: Open angle glaucoma

Registration Number: EUCTR2009-013178-42-BE

Lead Sponsor: Alcon Research, Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

1. Patients of either sex and any race, 18 years of age or older.
2. Patients diagnosed with open-angle glaucoma (with or without pseudoexfoliation or
pigment dispersion component) or confirmed ocular hypertension who would benefit
from a fixed combination medication, in the opinion of the Investigator.
NOTE: Patients are eligible if they are insufficiently responsive to an intraocular
pressure lowering monotherapy, as documented in the patients' medical records.
NOTE: Patients may currently be treated with unfixed or fixed combination IOPlowering
medications. Patients may be eligible if they are insufficiently responsive or
intolerant to a combination therapy (fixed or unfixed), excluding combination therapies
containing a prostaglandin analogue and a beta-blocker. Patients may be eligible if
they are well controlled on a combination therapy (fixed or unfixed) containing a
prostaglandin analogue and a beta-blocker.
3. Patients currently on a stable treatment (i.e., at least 30 days) with an IOP-lowering
medication.
4. Only patients who satisfy all Informed Consent requirements may be included in the
study. Section 18.4. lists the required elements of the Informed Consent, the origins of
which are derived from the Declaration of Helsinki, amended in 2002 (see Section
18.3.). The Informed Consent documents must be executed as follows: the patient must
read, sign, and date the Informed Consent document before any study-related
procedures are performed. The person who conducted the informed consent discussion
must also sign and date the Informed Consent document.
Only patients who are able to read, sign, and date the informed consent can be enrolled.
The Informed Consent form signed by patients must have been approved by the
IRB/IEC for the current study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria
Patients demonstrating any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of test article, safe participation in this study, or affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude patients from enrollment in this study:
Pregnancy:
1. Females of childbearing potential (those who are not surgically sterilized or at least two years post-menopausal) are excluded from participation in the study if they meet any one of the following conditions:
• They are currently pregnant or,
• They have a positive result on the urine pregnancy test at the Screen/Enrollment
Visit or, they intend to become pregnant during the study period or,
• They are breast-feeding or, they are not using highly effective birth control
measures:
o Hormonal – oral, implanted, topical, or injected contraceptives;
o Mechanical – spermicide in conjunction with a barrier such as a condom or
diaphragm or; IUD

Exclusion Criteria related to the disease condition being investigated (open-angle
glaucoma or ocular hypertension):

2. Patients with any form of glaucoma other than open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or confirmed ocular
hypertension.
3. Patients with iridocorneal angle Shaffer grade < 2 (extreme narrow angle with
complete or partial closure) in either eye, as measured by gonioscopy (see
Section 18.1.3.).
4. Patients with a cup/disc ratio greater than 0.80 (horizontal or vertical measurement) in either eye.
5. Patients with severe central visual field loss in either eye (see Section 9.4.6. for
details).

Exclusion Criteria related to ocular/systemic patient history or current ocular condition in either eye:

6. History of (i.e., within the last 3 months), or current chronic, recurrent, or severe ocular nfection, inflammation or inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis), or current other severe ocular pathology (including severe dry eye) that would affect the conduct of the study in the opinion of the Investigator.
7. History of ocular trauma within the past 6 months.
8. Intraocular laser surgery within the past 6 months.
9. Ocular laser surgery within the past 3 months.
10. Best-corrected visual acuity score worse than 55 ETDRS letters (equivalent to
approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal). See Section 9.4.9. for
details on the procedure.
11. History of, or current clinically relevant (in the opinion of the Investigator) or
progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
12. Any abnormality preventing reliable applanation tonometry.
13. History of or current bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-adrenergic blocking agent.
14. History of or current severe, unstable or uncontrolled cardiovascular, hepatic, or renal disease (e.g., sinus bradycardia, overt cardiac failure, greater than first degree
atrioventricular block, cardiogenic shock, clinically relevant angina or uncontrolled
hypertension) that would preclude the safe administration of a topical beta-adrenergic blocking agent.
15. History of spontaneous or current hypoglycemia or uncontrolled diabetes.
16. History of or current severe allergic rhinitis and bronchial hyper reactivity.
17. History of or current corneal dystrophies.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to describe the<br>safety of polyquaternium-preserved DuoTrav APS<br>dosed once daily for 12 months, in patients with open angle<br>glaucoma or ocular hypertension.<br>;Secondary Objective: ;Primary end point(s): Long-term safety of polyquaternium-preserved DuoTrav APS dosed once daily for 12 months, in patients with open-angle glaucoma or ocular hypertension<br>

Secondary Outcome Measures

Name	Time	Method

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