A Multi-Center, Parallel Group, Double-Masked, Randomized, Placebo-Controlled Study of Multiple Ocular Instillations of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease

Study of Diquafosol Tetrasodium Ophthalmic Solution in Subjects With Dry Eye Disease



Sponsors


Source

Merck Sharp & Dohme Corp.

Brief Summary

The purpose of this trial is to assess the effectiveness and safety of 2% diquafosol
tetrasodium ophthalmic solution versus placebo following 6 weeks of treatment in subjects
with mild to moderate dry eye disease.

Overall Status

Completed

Start Date

2004-06-01

Completion Date

2004-11-01

Primary Completion Date

2004-11-01

Phase

Phase 3

Study Type

Interventional

Primary Outcome

Measure

Change in dry eye testing measures

Secondary Outcome

Measure

Change in dry eye testing measures and symptoms

Enrollment

640

Condition


Intervention

Intervention Type

Drug

Intervention Name



Eligibility

Criteria

Inclusion Criteria:

- best corrected visual acuity in both eyes of at least +0.7

- six-month documented history of dry eye disease

- as least mild severity in 1 of the 5 dry eye symptoms

- corneal fluorescein staining of greater than or equal to 3 and less than or equal to 6
(out of 15)

Exclusion Criteria:

- permanent conjunctival goblet cell loss or scarring conditions

- ongoing contact lens wear

- current topical ophthalmic medication use

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Verification Date

2016-02-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Intervention Browse

Mesh Term

Pharmaceutical Solutions

Ophthalmic Solutions



Firstreceived Results Date

N/A

Removed Countries

Country

United States


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Double


Study First Submitted

November 22, 2006

Study First Submitted Qc

November 24, 2006

Study First Posted

November 27, 2006

Last Update Submitted

February 19, 2016

Last Update Submitted Qc

February 19, 2016

Last Update Posted

February 22, 2016


ClinicalTrials.gov processed this data on August 27, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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