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: 18.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 18.0Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2015-000736-15-ES
• Lead Sponsor: Alcon Research, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-31
• Last Update Posted: 19 March 2018

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