Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This cross-over study will investigate the efficacy and safety of BIMMD and TUDPF in a clinical setting.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Collaborator: Allergan
• Treatments: Bimatoprost; Ophthalmic Solutions; Pharmaceutical Solutions; Tetrahydrozoline

Criteria

Inclusion Criteria:

• A patient suffering from ocular hypertension, XFG or POAG and needs treatment in both eyes

• Patient is at least 18 years

• Patient is able and willing to participate in the study for the whole duration of the follow up and is willing to sign the consent form.

Exclusion Criteria:

• Unwilling to sign informed consent;

• Younger than 18 years old;

• Ocular condition that are of safety concern and that can interfere with the study results;

• Visual field defects with an MD value above -15dB on either eye on Humphrey (or the equivalent in Octopus) and/or threatening fixation

• Contact lens wearer;

• Closed/barely open anterior chamber angles or history of acute angle closure on either eye as assessed by gonioscopy;

• Ocular surgery (other than glaucoma surgery) or argon laser trabeculoplasty within the past three months on either eye;

• Glaucoma surgery within the past 6 months on either eye;

• Ocular inflammation/infection occurring within three months prior to pre-trial visit on either eye;

• Concomitant topical ocular medication that can interfere with study medication on either eye;

• Known hypersensitivity to any component of the trial drug solutions;

• Other abnormal condition or symptom preventing the patient from entering the trial, according to the Investigator's judgement;

• Refractive surgery patients at any time;

• Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing;

• Inability to adhere to treatment/visit plan;

• Have participated in any other Interventional clinical trial (i.e., requiring informed consent) involving an investigational drug within one month prior to pre-trial visit.

• History of COPD, asthma or heart failure