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

NCT02326090 | Completed Phase 2

• 1 other identifier: CL12002 / 14-110-0005
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (2)

• Corneal Fluorescein Staining

  Day 29

• Symptom Score

  Day 22 to 28

Study Arms (3)

cis-UCA ophthalmic solution 1.0%

ACTIVE COMPARATOR

One drop in each eye

Drug: cis-UCA ophthalmic solution 1.0%

cis-UCA ophthalmic solution 2.5%

ACTIVE COMPARATOR

One drop in each eye

Drug: cis-UCA ophthalmic solution 2.5%

Placebo ophthalmic solution

PLACEBO COMPARATOR

One drop in each eye

Drug: Placebo ophthalmic solution

Interventions

cis-UCA ophthalmic solution 1.0% DRUG

cis-UCA ophthalmic solution 1.0%

cis-UCA ophthalmic solution 2.5% DRUG

cis-UCA ophthalmic solution 2.5%

Placebo ophthalmic solution DRUG

Placebo ophthalmic solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herantis Pharma Plc.: lead
• ORA, Inc.: collaborator

Study Sites (1)

Unknown Facility

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: December 25, 2014
• Study Start: December 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 9, 2015

Record last verified: 2015-09

Locations

US (1)