NCT01468168

Brief Summary

To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in dry-eye disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

1.1 years

First QC Date

November 7, 2011

Last Update Submit

December 14, 2012

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

  • Tear volume increase from baseline

    baseline and 6 months

Study Arms (3)

DE-101 Ophthalmic Suspension High Dose

EXPERIMENTAL
Drug: DE-101 Ophthalmic Suspension

DE-101 Ophthalmic Suspension Low Dose

EXPERIMENTAL
Drug: DE-101 Ophthalmic Suspension

DE-101 Ophthalmic Suspension Vehicle

PLACEBO COMPARATOR
Drug: DE-101 Ophthalmic Suspension Vehicle

Interventions

DE-101 Ophthalmic SuspensionDRUG

Ophthalmic suspension; QID

DE-101 Ophthalmic Suspension High Dose
DE-101 Ophthalmic Suspension VehicleDRUG

Ophthalmic suspension vehicle; QID

DE-101 Ophthalmic Suspension Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals considered for entry into the study will be of either sex and any race who have:
  • a confirmed diagnosis of dry eye,
  • are willing to use no ocular treatments during the study other than study medication,
  • have a corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of +0.7 logarithm of the minimum angle of resolution (logMAR) or better in each eye,
  • will not use contact lenses during the study,
  • Females of child-bearing potential must have a negative urine pregnancy test and be willing to use an acceptable method of contraception to be eligible for, and continue participation in, the study,
  • years of age or older,
  • able to understand and provide written informed consent

You may not qualify if:

  • Subjects with any of the following are not eligible to participate in the study:
  • Fluorescein corneal staining or conjunctival staining that is too severe
  • Conditions requiring the use of ophthalmic prescription or over the counter medications during the study (except for study medications)
  • Any type of current punctal occlusion including punctal plugs, intracanalicular punctal plugs or cauterized puncta
  • Any type of ocular surgery within 90 days prior to Visit 1 (Day 1)
  • Known history of Steven-Johnson's syndrome, Riley-Day syndrome, and/or ocular pemphigoid
  • Ocular(including lid)disease/abnormality that may interfere with the study
  • Corneal transplant in either eye, at any time prior to enrollment in the study
  • Laser refractive surgery less than one year prior to Visit 1 (Day 1)
  • Conditions requiring the use of any systemic medication that is not ongoing at a stable dosage for at least 30 days prior to Visit 1 (Day 1)
  • Application of isotretinoin within 30 days prior to Visit 1 (Day 1)
  • Known allergy or sensitivity to any of the study medication components
  • Uncontrolled systemic conditions or other conditions which would confound the study evaluations or endanger the safety of the subject
  • A woman who is pregnant, nursing, or planning a pregnancy
  • Participation in another investigational drug or vaccine trial, or participation in such a trial within 30 days prior to Visit 1 (Day 1)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

New Port Beach, California, 92663, United States

Location

Unknown Facility

Parker, Colorado, 80134, United States

Location

Unknown Facility

Largo, Florida, 33773, United States

Location

Unknown Facility

Morrow, Georgia, 30260, United States

Location

Unknown Facility

Roswell, Georgia, 30076, United States

Location

Unknown Facility

Bangor, Maine, 04401, United States

Location

Unknown Facility

Kansas City, Missouri, 64111, United States

Location

Unknown Facility

St Louis, Missouri, 63131, United States

Location

Unknown Facility

Washington, Missouri, 63090, United States

Location

Unknown Facility

High Point, North Carolina, 27262, United States

Location

Unknown Facility

Cleveland, Ohio, 44115, United States

Location

Unknown Facility

Salt Lake City, Utah, 84107, United States

Location

Unknown Facility

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2011

First Posted

November 9, 2011

Study Start

October 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

December 17, 2012

Record last verified: 2012-12

Locations

US(13)