Pharmacokinetics, Safety and Tolerability of the Preservative-free Fixed Dose Combination of Tafluprost 0.0015% and Timolol 0.5% Eye Drops

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to investigate the pharmacokinetics, safety and tolerability of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (FDC) to those of preservative-free tafluprost 0.0015% and timolol 0.5% eye drops in healthy volunteers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01306461

Ocular Hypertension Open-angle Glaucoma

COMPLETED PHASE3

Tafluprost-Timolol Preservative-free Fixed Dose Combination (FDC) Superiority Study Against Monotherapies

NCT01292460

Ocular Hypertension Open-angle Glaucoma

COMPLETED PHASE3

Preservative-free Fixed-dose Combination of Tafluprost 0.0015% / Timolol 0.5% in Patients With Open-angle Glaucoma or Ocular Hypertension: Clinical Effectiveness, Tolerability and Safety in a Real World Setting

NCT04828057

Ocular Surface Disease Primary Open Angle Glaucoma

COMPLETED

Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation

NCT00918346

Open-Angle Glaucoma Ocular Hypertension

COMPLETED PHASE3

DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%

NCT01342081

Open Angle Glaucoma Ocular Hypertension

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tafluprost 0.0015%

Group Type ACTIVE_COMPARATOR

Preservative free tafluprost 0.0015% eye drops

Intervention Type DRUG

Preservative free tafluprost eye drops will be administered once daily at 09:00 into both eyes for seven days. For masking purposes vehicle eye drops will be administered in the evening at 21:00.

Timolol 0.5%

Group Type ACTIVE_COMPARATOR

Preservative free timolol 0.5% eye drops

Intervention Type DRUG

Preservative free timolol eye drops will be administered into both eyes twice daily at 9:00 and 21:00 for seven days

Fixed-dose combination of tafluprost 0.0015% and timolol 0.5%

Group Type EXPERIMENTAL

Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops

Intervention Type DRUG

Preservative free fixed-dose combination eye drops will be administered into both eyes once daily at 9:00 for seven days. For masking purposes vehicle eye drops will be administered in the evening at 21:00.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Preservative free tafluprost 0.0015% eye drops

Preservative free tafluprost eye drops will be administered once daily at 09:00 into both eyes for seven days. For masking purposes vehicle eye drops will be administered in the evening at 21:00.

Intervention Type DRUG

Preservative free timolol 0.5% eye drops

Preservative free timolol eye drops will be administered into both eyes twice daily at 9:00 and 21:00 for seven days

Intervention Type DRUG

Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops

Preservative free fixed-dose combination eye drops will be administered into both eyes once daily at 9:00 for seven days. For masking purposes vehicle eye drops will be administered in the evening at 21:00.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Aged 18 to 45 years
* Good general health
* Meet best corrected ETDRS visual acuity

Exclusion Criteria

* Significant systemic or ocular disease
* History of eye surgery, including refractive surgery
* Allergy or hypersensitivity to study drug
* Low heart rate (\<50 bpm)
* Clinically relevant low blood pressure
* Asthma
* Bradycardia
* Use of contact lenses within one week prior to screening or during the study
* Clinically significant obesity (body mass index \> 30 kg/m2)
* Blood donation within 2 months prior to screening
* Females who are pregnant or lactating and females not using adequate contraceptives

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes