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

Santen

Status and phase

Completed

Phase 2

Conditions

Dry Eye Disease

Treatments

Drug: DE-101 Ophthalmic Suspension

Drug: DE-101 Ophthalmic Suspension Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

26-005

Details and patient eligibility

About

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

Enrollment

183 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)