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

NCT02471105 | Unknown Phase 4

• 1 other identifier: S57304
• Study Type: interventional
• Target: 67
• Locations: 5 countries
• Sites: 7

Brief Summary

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

Conditions

Ocular Hypertension; Glaucoma

Outcome Measures

Primary Outcomes (1)

• the difference in mean IOP values between the 2 groups

  6 months

Secondary Outcomes (3)

• the difference in IOP values between the groups in change from baseline IOP

  month 3 and month 6

• the difference in mean IOP between the 2 groups

  month 3

• the difference in IOP between the 2 groups at each timepoints

  month 3 and month 6

Study Arms (2)

Lumigan 0.01% + Saflutan 15 µg/ml

EXPERIMENTAL

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

Drug: Preserved Bimatoprost 0.01%; Drug: Tafluprost Unit Dose Preservative Free 15microgram/ml

Saflutan 15 µg/ml + Lumigan 0.01%

EXPERIMENTAL

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

Drug: Preserved Bimatoprost 0.01%; Drug: Tafluprost Unit Dose Preservative Free 15microgram/ml

Interventions

Preserved Bimatoprost 0.01% DRUG

Eye drops solution Topical use Once in the evening 3 months

Also known as: BIMMD, Lumigan 0.01 %

Lumigan 0.01% + Saflutan 15 µg/ml; Saflutan 15 µg/ml + Lumigan 0.01%

Tafluprost Unit Dose Preservative Free 15microgram/ml DRUG

Eye drops solution Topical use Once in the evening 3 months

Also known as: TUDPF, Saflutan

Lumigan 0.01% + Saflutan 15 µg/ml; Saflutan 15 µg/ml + Lumigan 0.01%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Allergan: collaborator

Study Sites (7)

Hommer Ophthalmology Institute

Vienna, Austria

RECRUITING

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

San Paolo Hospital

Milan, Italy

NOT YET RECRUITING

Bietti Foundation

Rome, Italy

NOT YET RECRUITING

Clinical Research Centre Momorial A. de Rotschild

Geneva, Switzerland

NOT YET RECRUITING

Gloucestershire Hospitals NHS Foundation Trust

Gloucestershire, United Kingdom

NOT YET RECRUITING

Western Eye Hospital

London, United Kingdom

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 33818170 DERIVED

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma

Interventions

tafluprost

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Ingeborg Stalmans, Phd

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingeborg Stalmans, Phd

CONTACT

003216332372; ingeborg.stalmans@uzleuven.be

Sien Boons

CONTACT

0032163340391; sien.boons@uzleuven.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: June 15, 2015
• Study Start: September 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

IT (2); BE (1); GB (2); CH (1); AU (1)