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CompletedNCT00037661Updated Oct 2, 2015

Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients With Dry Eye

A Phase 3 interventional study of INS365 Ophthalmic Solution in Keratoconjunctivitis Sicca, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-02.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
222
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Comparative efficacy trial of INS365 Ophthalmic Solution and placebo in patients with dry eye.

02

Conditions studied

  • Keratoconjunctivitis Sicca

Keywords

  • dry eye
03

In context

Keratoconjunctivitis Sicca

797 studies on the registry are indexed under Keratoconjunctivitis Sicca; 56 are open to participants now.

This study's enrollment of 222 is above the median of 73 across 674 interventional studies indexed under Keratoconjunctivitis Sicca.

Browse Keratoconjunctivitis Sicca studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,160 studies on the registry; 134 are open to participants now.

Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • had LASIK surgery
  • had punctal occlusion or cauterization within last 3 months
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
222 participants (actual)
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00037661
Responsible party
Sponsor
First posted
May 20, 2002
Start date
Apr 2002
Primary completion
Mar 2003
Completion
Mar 2003
Last update
Oct 2, 2015
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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