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Safety, Tolerability and Pharmacokinetics of 0.5% and 2.5% Cis-UCA Eye Drops in Adult Healthy Volunteers (Phase I)

NCT01476332 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2012-05-17

No results posted yet for this study

Summary

The purpose of this two-part study is to evaluate safety, tolerability and pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops in comparison to placebo in adult healthy volunteers.

Conditions

  • Dry Eye

Interventions

DRUG

cis-urocanic acid 0,5% eye drops

one drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2

DRUG

cis-urocanic acid 2.5% eye drops

one drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2

DRUG

Placebo for cis-UCA, eye drops

one drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2

Sponsors & Collaborators

  • Kuopio University Hospital

    collaborator OTHER

  • Laurantis Pharma, Ltd.

    lead INDUSTRY

Principal Investigators

  • Kai Kaarniranta, Professor · Kuopio University Hospital, Department of Ophthalmology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01476332 on ClinicalTrials.gov