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

Phase 1

• Conditions: Ocular HypertensionOpen-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: EUCTR2016-000176-20-DE
• Lead Sponsor: Alcon Research Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-28
• Study Completion: 2018-07-13
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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 morning or 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) = 19 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