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

S

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

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

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

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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