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

• Sponsor: Santen Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01468168
• Collaborator: (none)
• Enrollment: 183
• Locations: 13
• Arms: 3
• Duration (Months): 13
• Patients Per Site: 14.1
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: DE-101 Ophthalmic Suspension; Drug: DE-101 Ophthalmic Suspension; Drug: DE-101 Ophthalmic Suspension Vehicle	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 183 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DE-101 Ophthalmic Suspension High Dose	Drug: DE-101 Ophthalmic Suspension; Ophthalmic suspension; QID
Experimental: DE-101 Ophthalmic Suspension Low Dose	Drug: DE-101 Ophthalmic Suspension; Ophthalmic suspension; QID
Placebo Comparator: DE-101 Ophthalmic Suspension Vehicle	Drug: DE-101 Ophthalmic Suspension Vehicle; Ophthalmic suspension vehicle; QID

Outcome Measures

Primary Outcome Measures

1. Tear volume increase from baseline [baseline and 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		New Port Beach	California	United States	92663
2		Parker	Colorado	United States	80134
3		Largo	Florida	United States	33773
4		Morrow	Georgia	United States	30260
5		Roswell	Georgia	United States	30076
6		Bangor	Maine	United States	04401
7		Kansas City	Missouri	United States	64111
8		Saint Louis	Missouri	United States	63131
9		Washington	Missouri	United States	63090
10		High Point	North Carolina	United States	27262
11		Cleveland	Ohio	United States	44115
12		Salt Lake City	Utah	United States	84107
13		Norfolk	Virginia	United States	23507

Sponsors and Collaborators

• Santen Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Santen Inc.
• ClinicalTrials.gov Identifier: NCT01468168
• Other Study ID Numbers: 26-005
• First Posted: Nov 9, 2011
• Last Update Posted: Dec 17, 2012
• Last Verified: Dec 1, 2012

• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases

Study Results

No Results Posted as of Dec 17, 2012