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OpenTrials
Completed

NCT Number: NCT00679718

A Study of INS365 Ophthalmic Solution in Patients With Moderate to Severe Dry Eye Disease

To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe dry eye disease.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Study type

Interventional

Phase

Phase 2

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Best corrected visual acuity of at least +0.7 ETDRS
  • Six month history of dry eye disease
  • Mild severity in two out of five symptoms
  • Unanesthetized Schirmer score of less than or equal to 7mm
  • Corneal fluorescein staining greater than or equal to 4 out of 15 or lissamine green conjunctival staining of greater than or equal to 5 out of 18

Exclusion criteria

  • Nasal stimulated Schirmer score of less than 3mm
  • Have ongoing ocular infection
  • Have congenitally absent meibomian or lacrimal glands
  • Have had punctal occlusion within a specified time prior to study
  • Wear contact lens and refuse to remove them
  • Have other excluded eye conditions.

Treatment and study plan

diquafosol tetrasodium (INS365) Ophthalmic Solution

Drug

Primary outcomes

  1. Schirmer scores

  2. Corneal staining

  3. Conjunctival staining

  4. Tear break-up time

  5. Change in artificial tear usage

  6. Patient-reported improvement of foreign body sensation

Secondary outcomes

  1. Visual acuity

  2. Investigator global severity assessment

  3. Patient-reported dry eye symptoms other than foreign body sensation

  4. Biomicroscopy

  5. Ophthalmoscopy

  6. IOP

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Patients With Moderate to Severe Dry Eye Disease

Important dates

Study start
2000
Primary completion
2000
Study completion
2000
First posted
May 19, 2008
Registry last updated
Aug 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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