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Diquafosol tetrasodium, 2%

Phase 3

Dry Eye Disease | Small molecule | Ophthalmology |Merck & Company, Inc.|Last Updated: Feb 22, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment1,391

FDA Designations

No designations recorded

Clinical trial landscape

Diquafosol tetrasodium, 2% · 3 trials · 1 indication

Phase 3 3
NCT00831662The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637)Dry Eye Disease
COMPLETED490 Analytics
NCT00600288Study of the Effect of Diquafosol Tetrasodium Ophthalmic Solution, 2% Versus Placebo in Dry Eye Subjects (P08634)Dry Eye Disease
COMPLETED261 Analytics
NCT00403975Study of Diquafosol Tetrasodium Ophthalmic Solution in Subjects With Dry Eye DiseaseDry Eye Disease
COMPLETED640 Analytics
PHASE3COMPLETED
The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637)
Dry Eye DiseaseUnlock trial analytics
PHASE3COMPLETED
Study of the Effect of Diquafosol Tetrasodium Ophthalmic Solution, 2% Versus Placebo in Dry Eye Subjects (P08634)
Dry Eye DiseaseUnlock trial analytics
PHASE3COMPLETED
Study of Diquafosol Tetrasodium Ophthalmic Solution in Subjects With Dry Eye Disease
Dry Eye DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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
Change in fluorescein staining scores of the cornea
6 weeks
Change in dry eye testing measures

Secondary Endpoints

Proportion of subjects that achieve a 2-or-more-unit reduction of fluorescein staining of the central cornea (NEI scale)
6 weeks
Safety and Tolerability
6 weeks
Change in dry eye testing measures and symptoms
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 2PLACEBO_COMPARATOR -
Arm 1EXPERIMENTAL -
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Diquafosol tetrasodium ophthalmic solution, 2%DRUGOne to two drops in each eye QID for 6 weeks
PlaceboDRUGOne to two drops in each eye QID for 6 weeks
Non-preserved saline solution (Placebo)DRUG1-2 drops administered in each eye 4 times a day for 6 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

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 t...

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Competitive Landscape -Dry Eye Disease 7 trials

Frequently asked questions about Diquafosol tetrasodium, 2%

What is Diquafosol tetrasodium, 2% used for?

Diquafosol tetrasodium, 2% is an investigational small molecule being developed for the treatment of Dry Eye Disease. It is an ophthalmic solution administered as eye drops. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.

Who makes Diquafosol tetrasodium, 2%?

Diquafosol tetrasodium, 2% is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is in Phase 3 clinical trials for Dry Eye Disease.

What phase is Diquafosol tetrasodium, 2% in?

Diquafosol tetrasodium, 2% is in Phase 3 clinical development for Dry Eye Disease. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. Three Phase 3 trials have been completed, with a total enrollment of 1,391 participants.

What clinical trials is Diquafosol tetrasodium, 2% in?

Diquafosol tetrasodium, 2% has completed three Phase 3 clinical trials: NCT00403975 with 640 participants, NCT00600288 with 261 participants, and NCT00831662 with 490 participants. All trials were randomized, double-blind, placebo-controlled studies in patients with Dry Eye Disease.

How does Diquafosol tetrasodium, 2% work?

Diquafosol tetrasodium, 2% is a small molecule that acts as a P2Y2 receptor agonist. It stimulates tear secretion and mucin production on the ocular surface, which helps to alleviate the symptoms of Dry Eye Disease. The drug is administered as an ophthalmic solution.