Effects of Topical Hypotensive Drugs on Circadian Ocular Perfusion Pressure and Ocular Blood Flow in Patients with Open-Angle Glaucoma - Circadian Ocular Perfusion Pressure

• Conditions: Open-Angle Glaucoma; MedDRA version: 9.1Level: LLTClassification code 10030856Term: Open-angle glaucoma

• Registration Number: EUCTR2007-005936-99-GR
• Lead Sponsor: Alcon Research, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-28
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female patients 18 years of age or older diagnosed with open-angle glaucoma (with or without pseudoexfoliative component) in at least one eye and requiring more than one IOP-lowering medication.
2. Patients must meet the following IOP entry criteria in at least one eye:
• For the qualifying eye(s), the mean IOP must be = 23 mmHg at least at one time
point and = 32 mmHg at all time points at the Eligibility/Period 1 Baseline (24-hour
assessment) Visit
• The mean IOP in either eye at any time point during Screening, Safety and
Eligibility/Period 1 Baseline Visits must not be greater than 32 mmHg
3. Only patients who satisfy all informed consent requirements may be included in the study. Only patients who are able to read, sign and date the Informed Consent Form can be enrolled. The Informed Consent form signed by the patients MUST have been approved by the independent Ethics Committee (IEC) for this study.
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. An original of the signed and dated Informed Consent document must be provided to the patient and one original signed document placed in the patient’s chart.
4. Patients must be able to discontinue use of all IOP-lowering medication(s) for a
minimum period of 3 days to 28 days prior to the Eligibility/Period 1 Baseline (24-hour
assessment) Visit and for 4 weeks between the treatment periods during the study. The investigator shall assess the minimum initial washout period based on the class of the patient’s current IOP-lowering medication.
5. Patients using topical ophthalmic and/or systemic non- IOP-lowering medications
(except for those listed in the Exclusion Criteria n°15) may be included in the study.
6. Patients must be willing to complete all required study visits.
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

1. Female of childbearing potential (those who are not surgically sterilized at least 3
months prior to study start or who are at least two years post-menopausal) are excluded
from participation in the study if they meet any one of the following.
• They are currently pregnant, or
• They have a positive results on the urine pregnancy test at the Screening 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:
- Hormonal – oral, implanted, topical, or injected contraceptives;
- Mechanical – spermicide in conjunction with a barrier such as a condom or
diaphragm or IUD
Note: All females of childbearing potential must consent to a urine pregnancy test upon entering and exiting the study.
Note: Instruct females of childbearing potential to immediately inform the investigator if they become pregnant during the study. Should this occur, the investigator shall immediately contact the sponsor.
Note: For non-sexually active females, abstinence may be regarded as an adequate
method of birth control; however if the patient becomes sexually active during the study, she must agree to use adequate birth control methods as defined above for the remainder of the study.
2. Patients with any form of glaucoma other than open-angle glaucoma (with or without pseudoexfoliative component).
3. Patients with severe central visual loss in either eye defined as sensitivity = 10dB in at least 2 of the 4 visual field test points closest to the point of fixation.
4. Patients with angle grade less than Grade III, as measured by gonioscopy. See
5. Patients with a cup/disc ratio greater than 0.8 in either eye.
6. Patients who wear contact lenses.
7. Patients who had previous intraocular surgery in the study eye(s) within 3 months
prior to the Screening Visit.
8. Patients who had previous glaucoma surgery in the study eye(s).
9. Patients with best corrected visual acuity worse than 0.6 logMAR score in either eye.
10. Patients who are currently on therapy or were on therapy with another investigational product within 30 days prior to the Screening Visit
11. Patients with diabetic retinopathy of any stage.
12. Patients who cannot safely discontinue the use of all glucocorticoid medication
administered by any route. Patients must have washed out of chronic glucocorticoids
for at least 4 weeks prior to the Screening Visit (period can be reduced to 2 weeks in
case of intermittent glucocorticoid therapy) and must be able to remain off these
medications for the duration of the study.
13. History of allergy or severe hypersensitivity to timolol maleate, carbonic anhydrase inhibitors, sulfonamide derivative, or to any components of the study medications in the opinion of the investigator. For listing of additional components present in the study medications, see the Clinical Investigator’s Brochure for AZARGA and the SPC for COMBIGAN
14. Cardiovascular diseases or uncontrolled hepatic or renal diseases that would require the use of medication as listed under exclusion criteria n°15 or would preclude the safe administration of a topical beta-blocker.
15. Concomitant systemic treatments with medications that could effect IOP, blood pressure or blood flow (e.g., beta-blockers, angiotensin converting enzyme inhibitors, calcium antagonists, alpha blockers, platelet inhibitors, anti-coagulant)
16. Recent (within 4 weeks of the Screening Visit) use of high–dose (> 1 gram daily)
s

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified