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

Sponsor

Herantis Pharma Plc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02326090

Collaborator

ORA, Inc. (Industry)

161

Enrollment

Location

Arms

Duration (Months)

40.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Drug: cis-UCA ophthalmic solution 1.0% Drug: cis-UCA ophthalmic solution 2.5% Drug: Placebo ophthalmic solution	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

161 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: cis-UCA ophthalmic solution 1.0% One drop in each eye	Drug: cis-UCA ophthalmic solution 1.0%
Active Comparator: cis-UCA ophthalmic solution 2.5% One drop in each eye	Drug: cis-UCA ophthalmic solution 2.5%
Placebo Comparator: Placebo ophthalmic solution One drop in each eye	Drug: Placebo ophthalmic solution

Arm

Intervention/Treatment

Active Comparator: cis-UCA ophthalmic solution 1.0%

One drop in each eye

Drug: cis-UCA ophthalmic solution 1.0%

Active Comparator: cis-UCA ophthalmic solution 2.5%

One drop in each eye

Drug: cis-UCA ophthalmic solution 2.5%

Placebo Comparator: Placebo ophthalmic solution

One drop in each eye

Drug: Placebo ophthalmic solution

Outcome Measures

Primary Outcome Measures

Corneal Fluorescein Staining [Day 29]
Symptom Score [Day 22 to 28]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Andover	Massachusetts	United States	01810

Sponsors and Collaborators

Herantis Pharma Plc.
ORA, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Herantis Pharma Plc.

ClinicalTrials.gov Identifier:

NCT02326090

Other Study ID Numbers:

CL12002 / 14-110-0005

First Posted:

Dec 25, 2014

Last Update Posted:

Sep 9, 2015

Last Verified:

Sep 1, 2015

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Pharmaceutical Solutions

Ophthalmic Solutions

Study Results

No Results Posted as of Sep 9, 2015