Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients

Phase I/II Prospective, Randomized, Double Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Compared to Placebo for the Treatment of Dry Eye Disease

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01118754

Enrollment

132

Registered

2010-05-07

Start date

2010-04-30

Completion date

2010-12-31

Last updated

2011-11-03

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

Conditions

Dry Eye

Keywords

Santen, Dry, Eye

Brief summary

The purpose of this study is to evaluate if DE-101 ophthalmic suspension will safely and effectively improve signs and or symptoms of dry eye disease.

Interventions

DRUGDE-101 ophthalmic suspension

Ophthalmic suspention; QID

DRUGDE-101 ophthalmic suspension vehicle

ophthalmic suspension vehicle; QID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* confirmed diagnosis of dry eye defined by protocol * 18 years or older, and sign written informed consent * negative pregnancy test and utilizing reliable contraceptive throughout study

Exclusion criteria

* use of any topical ocular medications * any ocular surgery within 90 days of study * laser refractive surgery within one year of study * ocular, lid disease/abnormalities that may interfere with the study * corneal transplants * uncontrolled systemic conditions * females who are pregnant or nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception * participated in another drug trial within 30 days prior to study

Design outcomes

Primary

Measure	Time frame
Total fluorescein corneal staining	8 weeks
Ocular Symptom Severity	8 weeks

Countries

United States

Outcome results

None listed

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