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INS365

Phase 3

Keratoconjunctivitis Sicca | Small molecule | Ophthalmology |Merck & Company, Inc.|Trials Updated: Oct 2, 2015

INS365 target and mechanism

ModalitySmall molecule

Also known as INS365 Ophthalmic Solution

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment222

FDA Designations

No designations recorded

INS365 clinical trials

INS365 · 1 trial · 1 indication

Phase 3 1
NCT00037661Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients With Dry EyeKeratoconjunctivitis Sicca
COMPLETED222 Analytics
PHASE3COMPLETED
Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients With Dry Eye
Keratoconjunctivitis SiccaUnlock trial analytics

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
INS365 Ophthalmic SolutionDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * have Non-Sjogren's associated dry eye disease with symptoms lasting greater than 6 months * had intermittent or regular artificial tear use within past 3 months Exclusion Criteria: * had LASIK surgery * had punctal occlusion or cauterization within last 3 months

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Frequently asked questions about INS365

What is INS365 used for?

INS365 is being developed for keratoconjunctivitis sicca, commonly known as dry eye disease. It is an ophthalmic solution studied in patients with this condition. The program is in Phase 3 clinical development, and the drug has not been approved by the FDA.

Who is developing INS365?

INS365 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The company is the sponsor of the clinical program evaluating INS365 ophthalmic solution in patients with keratoconjunctivitis sicca.

What phase is INS365 in?

INS365 is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The drug remains investigational and has not been approved by the FDA for any indication.

What clinical trials is INS365 in?

INS365 has been studied in one Phase 3 trial, NCT00037661, titled Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients With Dry Eye. The trial enrolled 222 patients with keratoconjunctivitis sicca, was randomized and double blind, and has been completed.

Is INS365 the same as INS365 Ophthalmic Solution?

Yes. INS365 Ophthalmic Solution is the same asset as INS365, referring to the ophthalmic formulation of the drug. Both names describe the small molecule being developed by Merck & Company, Inc. for keratoconjunctivitis sicca.