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CompletedNCT01118754Updated Nov 3, 2011

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

A Phase 1/2 interventional study of DE-101 ophthalmic suspension and DE-101 ophthalmic suspension in Dry Eye, sponsored by Santen Inc.. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-03.

Sponsored by Santen Inc. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dry Eye

Keywords

  • Santen
  • Dry
  • Eye
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's planned enrollment of 132 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Santen Inc. is the lead sponsor of 31 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
132 participants (estimated)

Study arms

  • Experimental
    DE-101 ophthalmic suspension high dose

    Drug: DE-101 ophthalmic suspension

  • Experimental
    DE-101 ophthalmic suspension low dose

    Drug: DE-101 ophthalmic suspension

  • Placebo comparator
    DE-101 ophthalmic suspension vehicle

    Drug: DE-101 ophthalmic suspension · Drug: DE-101 ophthalmic suspension vehicle

Interventions

  • DrugDE-101 ophthalmic suspension

    Ophthalmic suspention; QID

  • DrugDE-101 ophthalmic suspension

    Ophthalmic suspension; QID

  • DrugDE-101 ophthalmic suspension vehicle

    ophthalmic suspension vehicle; QID

06

What researchers measure

Primary outcomes

  1. Total fluorescein corneal staining

    Time frame: 8 weeks

  2. Ocular Symptom Severity

    Time frame: 8 weeks

07

Study locations

10 sites
  • Inglewood, California, United States
  • Torrance, California, United States
  • Bloomfield, Connecticut, United States
  • Indianapolis, Indiana, United States
  • New Albany, Indiana, United States
  • Gretna, Louisiana, United States
  • Bangor, Maine, United States
  • Cleveland, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • San Antonio, Texas, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01118754
Lead sponsor
Santen Inc.
Responsible party
Sponsor
First posted
May 7, 2010
Start date
Apr 2010
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Nov 3, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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Santen Inc.

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