Back to resultsPhase 2 Study With Cis-UCA Ophthalmic Solutions in Subjects With Dry Eye
Primary Purpose
Dry Eye Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cis-UCA ophthalmic solution 1.0%
cis-UCA ophthalmic solution 2.5%
Placebo ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
cis-UCA ophthalmic solution 1.0%
cis-UCA ophthalmic solution 2.5%
Placebo ophthalmic solution
Arm Description
One drop in each eye
One drop in each eye
One drop in each eye
Outcomes
Primary Outcome Measures
Corneal Fluorescein Staining
Symptom Score
Secondary Outcome Measures
Full Information
NCT ID
NCT02326090
First Posted
December 22, 2014
Last Updated
September 7, 2015
Sponsor
Herantis Pharma Plc.
Collaborators
ORA, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02326090
Brief Title
Phase 2 Study With Cis-UCA Ophthalmic Solutions in Subjects With Dry Eye
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 Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Herantis Pharma Plc.
Collaborators
ORA, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
161 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cis-UCA ophthalmic solution 1.0%
Arm Type
Active Comparator
Arm Description
One drop in each eye
Arm Title
cis-UCA ophthalmic solution 2.5%
Arm Type
Active Comparator
Arm Description
One drop in each eye
Arm Title
Placebo ophthalmic solution
Arm Type
Placebo Comparator
Arm Description
One drop in each eye
Intervention Type
Drug
Intervention Name(s)
cis-UCA ophthalmic solution 1.0%
Intervention Type
Drug
Intervention Name(s)
cis-UCA ophthalmic solution 2.5%
Intervention Type
Drug
Intervention Name(s)
Placebo ophthalmic solution
Primary Outcome Measure Information:
Title
Corneal Fluorescein Staining
Time Frame
Day 29
Title
Symptom Score
Time Frame
Day 22 to 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase 2 Study With Cis-UCA Ophthalmic Solutions in Subjects With Dry Eye
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