A Phase 2, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of 1.0% and 2.5% Cis-UCA Ophthalmic Solutions in Subjects With Dry Eye

Herantis Pharma Plc.0 sites161 target enrollmentDecember 2014

ConditionsDry Eye Syndrome

Interventionscis-UCA ophthalmic solution 2.5%Placebo ophthalmic solution cis-UCA ophthalmic solution 1.0%

Drugscis-UCA ophthalmic solution 1.0%cis-UCA ophthalmic solution 2.5%Placebo ophthalmic solution

Overview

Phase: Phase 2
Intervention: cis-UCA ophthalmic solution 2.5%
Conditions: Dry Eye Syndrome
Sponsor: Herantis Pharma Plc.
Enrollment: 161
Primary Endpoint: Symptom Score
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The objective of the Phase 2 study is to compare the safety and efficacy of cis-UCA Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

April 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Herantis Pharma Plc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Be at least 18 years of age;
•Provide written informed consent;
•Have a subject reported history of dry eye;
•Have a history of use or desire to use eye drops.

Exclusion Criteria

•Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters;
•Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
•Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
•Have used Restasis® within 30 days of Visit 1;
•Have any planned ocular and/or lid surgeries over the study period;
•Be a woman who is pregnant, nursing or planning a pregnancy;
•Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 4 (or early termination visit) if of childbearing potential;
•Have a known allergy and/or sensitivity to the study drug or its components;
•Have a condition or be in a situation which the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
•Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;