A study to investigate the combined effect of Simbrinza with other eye medication on Glaucoma

Phase 1

Conditions: Ocular Hypertension Open-angle Glaucoma
MedDRA version: 20.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 20.0Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2015-000736-15-DE

Lead Sponsor: Alcon Research, Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 280

Inclusion Criteria

1. Diagnosed with either open-angle glaucoma or ocular hypertension.
2. Must sign an informed consent form.
3. Willing and able to attend all study visits.
4. Other protcol-specified inclusion criteria may apply
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 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

1. Women of childbearing potential who are pregnant, breastfeeding, intend to become pregnant during the study, or not using adequate birth
control methods to prevent pregnancy throughout the study
2. Any form of glaucoma other than open-angle glucoma or ocular hypertension
3. Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in the protocol
4. Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study
5. Other protocol-specified exlcusion criteria may apply

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the additive intraocular pressure (IOP) lowering effect of Brinzolamide 1%/Brimonidine 0.2% (dosed twice per day (BID)) when added to a PGA in patients with open-angle glaucoma or ocular hypertension;Secondary Objective: Not applicable;Primary end point(s): Mean change from baseline in diurnal IOP ;Timepoint(s) of evaluation of this end point: Mean IOP of 09:00 and 11:00 at Week 6

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Mean diurnal IOP <br>2. Mean percentage change from baseline in diurnal IOP <br>3. Mean change from baseline in IOP<br>4. Mean Percentage change from baseline in IOP;Timepoint(s) of evaluation of this end point: 1. At week 6<br>2. At week 6<br>3. At 09:00 and 11:00 at Week 6<br>4. At 09:00 and 11:00 at Week 6