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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Dry Eye Disease

Treatments: Drug: Placebo; Drug: Diquafosol tetrasodium ophthalmic solution, 2%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00831662

P08637

03-113

Details and patient eligibility

About

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.

Enrollment: 490 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

490 participants in 2 patient groups, including a placebo group

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo

Arm 1

Experimental group

Treatment:

Drug: Diquafosol tetrasodium ophthalmic solution, 2%