Keratoconjunctivitis Sicca
Conditions
Brief summary
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.
Interventions
R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.
R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.
DRUGPlacebo
Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.
Sponsors
Rigel Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Corneal Fluorescein Staining of the Inferior Cornea Region. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| R348 Ophthalmic Solution, 0.2% R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks. | 67 |
| R348 Ophthalmic Solution, 0.5% R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks. | 68 |
| Placebo Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.
Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks. | 69 |
| Total | 204 |
Baseline characteristics
| Characteristic | R348 Ophthalmic Solution, 0.2% | R348 Ophthalmic Solution, 0.5% | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 62.4 Years STANDARD_DEVIATION 11.59 | 63.3 Years STANDARD_DEVIATION 11.5 | 61.5 Years STANDARD_DEVIATION 15.2 | 62.4 Years STANDARD_DEVIATION 12.8 |
| Sex: Female, Male Female | 54 Participants | 54 Participants | 54 Participants | 162 Participants |
| Sex: Female, Male Male | 13 Participants | 14 Participants | 15 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 36 / 67 | 46 / 68 | 31 / 69 |
| serious Total, serious adverse events | 3 / 67 | 1 / 68 | 2 / 69 |
Outcome results
Primary
Change of Corneal Fluorescein Staining of the Inferior Cornea Region.
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.
Time frame: Baseline to Week 12
Population: The intent to treat population (ITT) included all randomized subjects who administered study medication. The primary analysis was performed on the ITT population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| R348 Ophthalmic Solution, 0.2% | Change of Corneal Fluorescein Staining of the Inferior Cornea Region. | -1.00 units on a scale (Likert) |
| R348 Ophthalmic Solution, 0.5% | Change of Corneal Fluorescein Staining of the Inferior Cornea Region. | -0.78 units on a scale (Likert) |
| Placebo | Change of Corneal Fluorescein Staining of the Inferior Cornea Region. | -0.78 units on a scale (Likert) |