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Trial record 1 of 1 for:    Cis-UCA | United States
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Phase 2 Study With Cis-UCA Ophthalmic Solutions in Subjects With Dry Eye

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ClinicalTrials.gov Identifier: NCT02326090
Recruitment Status : Completed
First Posted : December 25, 2014
Last Update Posted : September 9, 2015
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
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 : December 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

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



Primary Outcome Measures :
  1. Corneal Fluorescein Staining [ Time Frame: Day 29 ]
  2. Symptom Score [ Time Frame: Day 22 to 28 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326090


Locations
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United States, Massachusetts
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Herantis Pharma Plc.
ORA, Inc.

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Responsible Party: Herantis Pharma Plc.
ClinicalTrials.gov Identifier: NCT02326090     History of Changes
Other Study ID Numbers: CL12002 / 14-110-0005
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions