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

September 7, 2015 updated by: Herantis Pharma Plc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Andover, Massachusetts, United States, 01810

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Corneal Fluorescein Staining
Time Frame: Day 29
Day 29
Symptom Score
Time Frame: Day 22 to 28
Day 22 to 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herantis Pharma Plc.

Collaborators

ORA, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

December 22, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (ESTIMATE)

December 25, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 9, 2015

Last Update Submitted That Met QC Criteria

September 7, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL12002 / 14-110-0005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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