The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637)

Dry Eye Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831662
• Other study ID #: P08637
• Secondary ID: 03-113
• Status: Completed
• Phase: Phase 3
• First received: January 27, 2009
• Last updated: December 21, 2014
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: December 2014
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to confirm the safety and efficacy of diquafosol tetrasodium ophthalmic solution, 2% vs. placebo, in subjects with dry eye disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 490
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have best corrected visual acuity in both eyes of at least +0.7 or better

• Central corneal staining of 3 on the NEI scale

• If female, are non-pregnant or non-lactating

• Have a history of dry eye disease in both eyes

• Have normal lid anatomy

Exclusion Criteria:

• Unable to withhold the use of contact lenses during the study or 2 weeks prior to the study

• Have had ocular surface surgery within the past year

• Are considered legally blind in one eye

• Have a serious medical condition which could confound study assessments

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Disease
• Eye Diseases

Intervention

Drug:
• Diquafosol tetrasodium ophthalmic solution, 2%
One to two drops in each eye QID for 6 weeks
• Placebo
One to two drops in each eye QID for 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Tauber J, Davitt WF, Bokosky JE, Nichols KK, Yerxa BR, Schaberg AE, LaVange LM, Mills-Wilson MC, Kellerman DJ. Double-masked, placebo-controlled safety and efficacy trial of diquafosol tetrasodium (INS365) ophthalmic solution for the treatment of dry eye. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects that achieve clearing of fluorescein staining of the central cornea (NEI scale). Subjects must have a score of 0 on the NEI scale at Week 6 to be considered responders.		6 weeks	No
Secondary	Proportion of subjects that achieve a 2-or-more-unit reduction of fluorescein staining of the central cornea (NEI scale)		6 weeks	No