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

Rigel Pharmaceuticals logo

Rigel Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Keratoconjunctivitis Sicca

Treatments

Drug: R348 Ophthalmic Solution, 0.2%
Drug: R348 Ophthalmic Solution, 0.5%
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01900249
C-932348-003

Details and patient eligibility

About

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.

Enrollment

204 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

204 participants in 3 patient groups, including a placebo group

R348 Ophthalmic Solution, 0.2%
Active Comparator group
Description:
R348 Ophthalmic Solution, 0.2%
Treatment:
Drug: R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.5%
Active Comparator group
Description:
R348 Ophthalmic Solution, 0.5%
Treatment:
Drug: R348 Ophthalmic Solution, 0.5%
Placebo
Placebo Comparator group
Description:
Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.
Treatment:
Drug: Placebo

Trial contacts and locations

20

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Data sourced from clinicaltrials.gov

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