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

Phase 1

• Conditions: Ocular Hypertension Open-angle Glaucoma; MedDRA version: 19.0 Level: PT Classification code 10030043 Term: Ocular hypertension System Organ Class: 10015919 - Eye disorders; MedDRA version: 19.0 Level: PT Classification code 10030348 Term: Open angle glaucoma System Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2016-000176-20-FR
• Lead Sponsor: Alcon Research Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-09
• Study Completion: 2018-07-13
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 134

Inclusion Criteria

- Diagnosis of open-angle glaucoma (including pseudoexfoliation or pigment dispersion glaucoma) or ocular hypertension
- Currently on treatment with Travoprost 0.004%fTimolol 0.5% prescribed as approved in the country, on evening dosing for at least 28 days prior to screening, and In the opinion of the Investigator may benefit from further lOP lowering
- Mean lOP measurements at both the Eligibility 1 and Eligibility 2 visits, in at least 1 eye (the same eye(s) = 21 and = 28 mmHg at 9:00 while on a Travoprost 0.004%/ Timolol 0.5% solution)
- Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/Ethics Committee
- Willing and able to attend all study visits
- Other protocol-defined 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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

- Women of childbearing potential: not postmenopausal for at least 1 year or less than 6 weeks since sterilization, currently pregnant; have a positive result on the urine pregnancy test at Screening; intend to become pregnant during the study period; breast-feeding; or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
- Any form of glaucoma other than open-angle glaucoma or ocular hypertension
- Severe central visual field loss in either eye
- Chronic, recurrent or severe Inflammatory eye disease In either eye
- Ocular trauma in either eye within the past 6 months prior to the Screening visit
- Ocular infection or ocular inflammation in either eye within the past 3 months prior to the Screening visit
- Retinal degeneration, diabetic retinopathy, or retinal detachment in either eye
- Best-corrected visual acuity score worse than 55 ETDRS letters (equivalent to approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal) in either eye
- Other ocular pathology (including severe dry eye) in either eye that may, in the opinion of the Investigator, preclude the safe administration of any study medication
- Intraocular surgery in either eye within the past 6 months prior to the Screening visit
- Ocular laser surgery in either eye within the past 3 months prior to the Screening visit
- Any other condition including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study
- Asthma, history of asthma, or severe chronic obstructive pulmonary disease
- Other protocol-defined exclusion criteria may apply

Study & Design

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