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

Santen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dry Eye

Treatments: Drug: DE-101 ophthalmic suspension vehicle; Drug: DE-101 ophthalmic suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT01118754

26-004

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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132 participants in 3 patient groups, including a placebo group

DE-101 ophthalmic suspension high dose

Experimental group

Treatment:

Drug: DE-101 ophthalmic suspension

Drug: DE-101 ophthalmic suspension

DE-101 ophthalmic suspension low dose

Experimental group

Treatment:

Drug: DE-101 ophthalmic suspension

Drug: DE-101 ophthalmic suspension

DE-101 ophthalmic suspension vehicle

Placebo Comparator group

Treatment:

Drug: DE-101 ophthalmic suspension

Drug: DE-101 ophthalmic suspension

Drug: DE-101 ophthalmic suspension vehicle