Tafluprost-Timolol Fixed Dose Combination Non-Inferiority Study Against Concomitant Administrations

NCT01306461 | Completed Phase 3

• 1 other identifier: 201051
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy and safety of the preservative-free fixed-dose combination of tafluprost and timolol (FDC) to concomitant administration of tafluprost and timolol. This study will enroll patients who have ocular hypertension or glaucoma. The study schedule includes seven visits to the study site and three stages:

• washout of 5 days to 4 weeks depending on current glaucoma medication (if any)
• 6-month study treatment period
• 1-3 weeks post-study period

Conditions

Ocular Hypertension; Open-angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the average diurnal intra-ocular pressure (IOP) at 6 months

  6 months

Secondary Outcomes (2)

• Change from baseline in average diurnal IOP at 2 weeks, 6 weeks and 3 months

  2 weeks, 6 weeks and 3 months

• Change from baseline in timewise IOPs

  2 weeks, 6 weeks, 3 months and 6 months

Study Arms (2)

Timolol and Tafluprost

ACTIVE COMPARATOR

Concomitant administration of preservative-free timolol and tafluprost eye drops

Drug: Timolol and Tafluprost

Fixed Dose Combination of tafluprost and timolol

EXPERIMENTAL

Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops

Drug: Fixed Dose Combination of tafluprost and timolol

Interventions

Timolol and Tafluprost DRUG

Preservative-free Timolol eye drops administered twice daily concomitantly with preservative-free Tafluprost eye drops administered once daily Treatment period 6 months

Timolol and Tafluprost

Fixed Dose Combination of tafluprost and timolol DRUG

Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops administered once daily. For masking purposes also: vehicle for timolol administered twice daily Treatment period 6 months

Fixed Dose Combination of tafluprost and timolol

Eligibility Criteria

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

You may qualify if:

• Aged 18 years or more
• A diagnosis of ocular hypertension or open-angle glaucoma
• Meet specific IOP level at visit 1 (screening)and visit 2 (baseline)
• Meet specific visual acuity score
• Are willing to follow instructions
• Have provided a written informed consent

You may not qualify if:

• Females who are pregnant, nursing or planning pregnancy
• IOP greater than 36 mmHg at any time point at screening or baseline
• Diagnosis of angle-closure glaucoma or secondary glaucoma other than capsular or pigmentary glaucoma in either eye
• Suspected contraindication or hypersensitivity to study medications tafluprost or timolol (e.g. asthma, low pulse) or to wash-out medication brinzolamide
• Glaucoma filtration surgery or any other ocular surgery (including ocular laser procedures) within 6 months prior to Screening
• Use of contact lenses at Screening or during the study
• Presence of any abnormality or significant illness that could be expected to interfere with the patient safety or study parameters
• Current participation in another clinical trial within the last 30 days

Sponsors & Collaborators

• Santen Oy: lead

Study Sites (1)

Unknown Facility

Debrecen, Hungary

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle

Interventions

Timolol; tafluprost

Condition Hierarchy (Ancestors)

Eye Diseases; Glaucoma

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Officials

• Auli Ropo, M.D.

  Santen Oy

  STUDY DIRECTOR

• Clemens Vass, M.D.

  Medical University Vienna, Austria

  PRINCIPAL INVESTIGATOR

• Marieta Kostianeva, M.D.

  University Mulitiprofile Hospital for Active Treatment Sv.Georgi, Bulgaria

  PRINCIPAL INVESTIGATOR

• Eva Ruzickova, M.D.

  Vseobecna fakultni nemocnice v Praze, Czech Republic

  PRINCIPAL INVESTIGATOR

• Gábor Holló

  Semmelweis Egyetem, Hungary

  PRINCIPAL INVESTIGATOR

• Guna Laganovska, M.D.

  P. Stradina Clinical University Hospital, Latvia

  PRINCIPAL INVESTIGATOR

• Maria L. Ribeiro, M.D.

  Aibili-Associação p/ Investigação Biomédica e Inovação em Luz e Imagem (AIBILI), Portugal

  PRINCIPAL INVESTIGATOR

• Julián García-Feijóo, M.D.

  Hospital Clinico San Carlos, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2011
• First Posted: March 1, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 8, 2012

Record last verified: 2012-06

Locations

HU (1)