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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02326090

Enrollment

161

Registered

2014-12-25

Start date

2014-12-31

Completion date

2015-04-30

Last updated

2015-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndrome

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.

Interventions

DRUGcis-UCA ophthalmic solution 1.0%

DRUGcis-UCA ophthalmic solution 2.5%

DRUGPlacebo ophthalmic solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
Corneal Fluorescein Staining	Day 29
Symptom Score	Day 22 to 28

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026