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

NCT ID: NCT02471105

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-12-31

Brief Summary

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

Detailed Description

• A prospective, randomized, investigator-masked, crossover comparison;
• Ocular hypertension or glaucoma (XFG or POAG) patients and who consent to participate will be enrolled in this study
• Patients will be scheduled for a screening visit IOP assessment (IOP measurements at 08:30, 12:30 and 16:30 (±1 hour).
• Patients who are on therapy at the screening visit and who consent to participate will undergo a washout period for 4 weeks (depending on therapy) before the baseline visit;
• Patient can under the washout period be given brinzolamide (Azopt) if needed, Azopt should then be discontinued 5 days before baseline visit;
• After the screening visit (and after wash-outperiod for treated patients) patients will be scheduled to undergo a baseline visit IOP assessment (IOP measurements at 08:30, 12:30 and 16:30 (± 1 hour with a minimum of 3 hours between readings) and will then be randomized for Period 1 to receive either BIMMD drops once in the evening (20:30) or TUDPF drops once in the evening (20:30) for 3 month
• After 3 month, patients will be switched for Period 2, to the opposite treatment (e.g. switched to either BIMMD or TUDPF) to be dosed in the evening;
• After another 3 months they will undergo the final evaluation of IOP levels and of tolerability;
• Intermediate safety visits may be scheduled at the discretion of the investigator.

Conditions

Ocular Hypertension; Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lumigan 0.01% + Saflutan 15 µg/ml

Bimatoprost 0.01 % Eye drops solution Topical use Once in the evening 3 months

Group Type: EXPERIMENTAL

Preserved Bimatoprost 0.01%

Intervention Type: DRUG

Eye drops solution Topical use Once in the evening 3 months

Tafluprost Unit Dose Preservative Free 15microgram/ml

Intervention Type: DRUG

Eye drops solution Topical use Once in the evening 3 months

Saflutan 15 µg/ml + Lumigan 0.01%

Tafluprost Unit Dose Preservative Free 15microgram/ml Eye drops solution Topical use Once in the evening 3 months

Group Type: EXPERIMENTAL

Preserved Bimatoprost 0.01%

Intervention Type: DRUG

Eye drops solution Topical use Once in the evening 3 months

Tafluprost Unit Dose Preservative Free 15microgram/ml

Intervention Type: DRUG

Eye drops solution Topical use Once in the evening 3 months

Interventions

Preserved Bimatoprost 0.01%

Eye drops solution Topical use Once in the evening 3 months

Intervention Type: DRUG

Tafluprost Unit Dose Preservative Free 15microgram/ml

Eye drops solution Topical use Once in the evening 3 months

Intervention Type: DRUG

Other Intervention Names

BIMMD; Lumigan 0.01 %; TUDPF; Saflutan

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ingeborg Stalmans, Phd

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

Hommer Ophthalmology Institute

Vienna, , Austria

Site Status: RECRUITING

UZ Leuven

Leuven, Vlaams Brabant, Belgium

Site Status: RECRUITING

San Paolo Hospital

Milan, , Italy

Site Status: NOT_YET_RECRUITING

Bietti Foundation

Rome, , Italy

Site Status: NOT_YET_RECRUITING

Clinical Research Centre Momorial A. de Rotschild

Geneva, , Switzerland

Site Status: NOT_YET_RECRUITING

Gloucestershire Hospitals NHS Foundation Trust

Gloucestershire, , United Kingdom

Site Status: NOT_YET_RECRUITING

Western Eye Hospital

London, , United Kingdom

Site Status: NOT_YET_RECRUITING

Countries

Austria; Belgium; Italy; Switzerland; United Kingdom

Central Contacts

Ingeborg Stalmans, Phd

Role: CONTACT

ingeborg.stalmans@uzleuven.be

003216332372

Sien Boons

Role: CONTACT

sien.boons@uzleuven.be

0032163340391

Facility Contacts

Anton Hommer

Role: primary

Ingeborg Stalmans, Phd

Role: primary

ingborg.stalmans@uzleuven.be

003216332372

Sien Boons, Optometrist

Role: backup

sien.boons@uzleuven.be

003216340391

Luca Rossetti

Role: primary

francesco Oddone

Role: primary

Gordana Megevand

Role: primary

Andrew McNaught

Role: primary

Francesca Cordeiro

Role: primary

References

Lemmens S, Rossetti L, Oddone F, Sunaric-Megevand G, Hommer A, Vandewalle E, Francesca Cordeiro M, McNaught A, Montesano G, Stalmans I. Comparison of preserved bimatoprost 0.01% with preservative-free tafluprost: A randomised, investigator-masked, 3-month crossover, multicentre trial, SPORT II. Eur J Ophthalmol. 2021 Apr 5:11206721211006573. doi: 10.1177/11206721211006573. Online ahead of print.

Reference Type: DERIVED

PMID: 33818170 (View on PubMed)

Other Identifiers

S57304

Identifier Type: -

Identifier Source: org_study_id