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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I, Randomized, Double-masked, 3-period Cross-over Clinical Study to Compare the Pharmacokinetics, Safety and Tolerability of the Preservative-free Fixed Dose Combination of Tafluprost 0.0015% and Timolol 0.5% Eye Drops to Those of Preservative-free Tafluprost 0.0015% and Timolol 0.5% Eye Drops in Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Preservative free tafluprost 0.0015% eye drops
* Drug: Preservative free timolol 0.5% eye drops
* Drug: Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tafluprost 0.0015%<br> | Drug: Preservative free tafluprost 0.0015% eye drops<br>* 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.<br>|
| Active Comparator: Timolol 0.5%<br> | Drug: Preservative free timolol 0.5% eye drops<br>* Preservative free timolol eye drops will be administered into both eyes twice daily at 9:00 and 21:00 for seven days<br>|
| Experimental: Fixed-dose combination of tafluprost 0.0015% and timolol 0.5%<br> | Drug: Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops. | The primary evaluation of pharmacokinetics will be based on the plasma concentration of tafluprost acid and timolol. | There are 3 cross-over treatment periods, plasma concentrations will be measured on Day 1 and Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops. | The changes from screening/baseline will be evaluated in following variables:visual acuity, IOP, biomicroscopy and ophthalmoscopy findings and drop discomfort. Adverse events will be followed from screening to post-study visit. | Day 1 and Day 7 of treatment periods I, II and III. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics