Safety and Efficacy Study of DE-110 Ophthalmic Suspension for the Treatment of Dry Eye Disease

A Phase II, Prospective, Randomized, Observer-masked, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of Two Concentrations Compared to Placebo for the Treatment of Dry Eye Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01239069

Enrollment

140

Registered

2010-11-11

Start date

2010-11-30

Completion date

2011-10-31

Last updated

2014-05-21

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

Conditions

Dry Eye

Brief summary

Investigate the Safety and Efficacy of Two Concentrations of DE-110 Compared to Placebo for the Treatment of Dry Eye Disease

Interventions

DRUGDE-110 ophthalmic suspension high dose

ophthalmic suspension; high dose; QID

DRUGDE-110 ophthalmic suspension low dose

ophthalmic suspension; low dose; QID

OTHERPlacebo

DE-110 ophthalmic suspension vehicle;QID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Confirmed diagnosis of dry eye * Not wear contact lenses during study * 18 years or older * Understand and provide written consent * Negative pregnancy test and use acceptable method of contraception

Exclusion criteria

* Use of any topical ocular medication * Any type of ocular surgery * Diagnosis of on-going ocular infection and/or allergic conjunctivitis * Uncontrolled systemic conditions/lid abnormalities * Corneal transplants * Females who are pregnant, nursing or planning a pregnancy * Participation in another drug trial concurrently or within 30 days prior to study

Design outcomes

Primary

Measure	Time frame
Efficacy of DE-110	12 weeks

Secondary

Measure	Time frame
Individual Response Rate	12 weeks
Individual Efficacy	12 weeks
Individual Symptoms	12 weeks

Countries

United States

Outcome results

None listed

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