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

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

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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