Andover, Massachusetts, 01810, United States
NCT Number: NCT02326090
Phase 2 Study With 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.
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
cis-UCA ophthalmic solution 1.0%
Drugcis-UCA ophthalmic solution 2.5%
DrugPlacebo Ophthalmic Solution
DrugPrimary outcomes
-
Corneal Fluorescein Staining
Time frame: Day 29
-
Symptom Score
Time frame: Day 22 to 28
Sponsors and collaborators
Lead sponsor
Herantis Pharma Plc.
Industry
Collaborators
- ORA, Inc.
Registry information
Official study 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
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Dec 25, 2014
- Registry last updated
- Sep 9, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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