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

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468168
• Other study ID #: 26-005
• Status: Completed
• Phase: Phase 2
• First received: November 7, 2011
• Last updated: December 14, 2012
• Start date: October 2011
• Est. completion date: November 2012

Study information

• Verified date: December 2012
• Source: Santen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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,

• 18 years of age or older,

• able to understand and provide written informed consent

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• DE-101 Ophthalmic Suspension
Ophthalmic suspension; QID
• DE-101 Ophthalmic Suspension
Ophthalmic suspension; QID
• DE-101 Ophthalmic Suspension Vehicle
Ophthalmic suspension vehicle; QID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Santen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear volume increase from baseline		baseline and 6 months