Phase 2 Study With Cis-UCA Ophthalmic Solutions in Subjects With Dry Eye

Phase 2

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: cis-UCA ophthalmic solution 1.0%; Drug: Placebo ophthalmic solution; Drug: cis-UCA ophthalmic solution 2.5%

• Registration Number: NCT02326090
• Lead Sponsor: Herantis Pharma Plc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-22
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-25
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-07
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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.

Key

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;
• Be unable or unwilling to follow instructions, including participation in all study assessments and visits.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cis-UCA ophthalmic solution 1.0%	cis-UCA ophthalmic solution 1.0%	One drop in each eye
Placebo ophthalmic solution	Placebo ophthalmic solution	One drop in each eye
cis-UCA ophthalmic solution 2.5%	cis-UCA ophthalmic solution 2.5%	One drop in each eye

Primary Outcome Measures

Name	Time	Method
Symptom Score	Day 22 to 28
Corneal Fluorescein Staining	Day 29