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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Dry Eye Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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cis-UCA ophthalmic solution 1.0%

One drop in each eye

Group Type ACTIVE_COMPARATOR

cis-UCA ophthalmic solution 1.0%

Intervention Type DRUG

cis-UCA ophthalmic solution 2.5%

One drop in each eye

Group Type ACTIVE_COMPARATOR

cis-UCA ophthalmic solution 2.5%

Intervention Type DRUG

Placebo ophthalmic solution

One drop in each eye

Group Type PLACEBO_COMPARATOR

Placebo ophthalmic solution

Intervention Type DRUG

Interventions

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cis-UCA ophthalmic solution 1.0%

Intervention Type DRUG

cis-UCA ophthalmic solution 2.5%

Intervention Type DRUG

Placebo ophthalmic solution

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No