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

Herantis Pharma

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndrome

Treatments: Drug: cis-UCA ophthalmic solution 2.5%; Drug: cis-UCA ophthalmic solution 1.0%; Drug: Placebo ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02326090

CL12002 / 14-110-0005

Details and patient eligibility

About

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.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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161 participants in 3 patient groups, including a placebo group

cis-UCA ophthalmic solution 1.0%

Active Comparator group

Description:

One drop in each eye

Treatment:

Drug: cis-UCA ophthalmic solution 1.0%

cis-UCA ophthalmic solution 2.5%

Active Comparator group

Description:

One drop in each eye

Treatment:

Drug: cis-UCA ophthalmic solution 2.5%

Placebo ophthalmic solution

Placebo Comparator group

Description:

One drop in each eye

Treatment:

Drug: Placebo ophthalmic solution