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OpenTrials
Completed

NCT Number: NCT01900249

To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca

The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.

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Key information

Conditions

Keratoconjunctivitis Sicca Conjunctival Diseases Conjunctivitis Corneal Diseases Dry Eye Syndromes Eye Diseases Keratitis Keratoconjunctivitis Lacrimal Apparatus Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sall Research Medical Center, Artesia, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A history of dry eye (based on the date of initial dry eye symptoms)
  • Use of over-the-counter (OTC) and/or prescription eye drops for dry eye symptoms
  • Corneal fluorescein staining score of at least 2 in the inferior region

Exclusion criteria

  • History of, or a concurrent clinically significant illness, medical condition (other than Keratoconjunctivitis Sicca or Sjögren's syndrome), or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study.
  • Use of ophthalmic cyclosporine within 45 days of Visit 1.
  • Use of any topical ophthalmic steroid within 2 weeks of Visit 1.
  • Have worn contact lenses or anticipate using contact lenses during the study.
  • Have a condition or be in a situation that the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
  • Have a history of alcohol or substance abuse that, in the judgment of the Investigator, may impair or risk the subject's full participation in the study.

Treatment and study plan

R348 Ophthalmic Solution, 0.2%

Drug

R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.

Other names: R932348

R348 Ophthalmic Solution, 0.5%

Drug

R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.

Other names: R932348

Placebo

Drug

Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.

Primary outcomes

  1. Change of Corneal Fluorescein Staining of the Inferior Cornea Region.

    Time frame: Baseline to Week 12

    Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea.

Sponsors and collaborators

Lead sponsor

Rigel Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.2% and 0.5% R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca

Acronym: DROPS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 16, 2013
Registry last updated
Oct 3, 2016

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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