Trial Outcomes & Findings for Physician's Evaluation of Cyclosporine Ophthalmic Emulsion 0.05% (NCT NCT00827255)
NCT ID: NCT00827255
Last Updated: 2019-04-25
Results Overview
Percentage of patients with complete clearing of corneal staining at month 12. Corneal staining is evaluated following administration of fluorescein dye into the eye. Complete clearing is defined as the absence of corneal staining.
COMPLETED
35 participants
Month 12
2019-04-25
Participant Flow
Retrospective analysis. Patients may have been treated with Restasis® (cyclosporine ophthalmic emulsion 0.05%) in addition to other medications during the course of the study.
Participant milestones
| Measure |
Patients Who Received Restasis®
Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Physician's Evaluation of Cyclosporine Ophthalmic Emulsion 0.05%
Baseline characteristics by cohort
| Measure |
Patients Who Received Restasis®
n=35 Participants
Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
|
|---|---|
|
Age, Customized
<40 years
|
7 participants
n=5 Participants
|
|
Age, Customized
Between 40 and 49 years
|
2 participants
n=5 Participants
|
|
Age, Customized
Between 50 and 59 years
|
8 participants
n=5 Participants
|
|
Age, Customized
Between 60 and 69 years
|
5 participants
n=5 Participants
|
|
Age, Customized
Between 70 and 79 years
|
11 participants
n=5 Participants
|
|
Age, Customized
>=80 years
|
2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: ITT population, which consisted of all patients included in the study, with documented presence of corneal staining at baseline. For this outcome measure, a total of 18 patients had documented corneal staining at baseline.
Percentage of patients with complete clearing of corneal staining at month 12. Corneal staining is evaluated following administration of fluorescein dye into the eye. Complete clearing is defined as the absence of corneal staining.
Outcome measures
| Measure |
Patients Who Received Restasis®
n=18 Participants
Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
|
|---|---|
|
Percentage of Patients With Complete Clearing of Corneal Staining at Month 12
|
33.3 Percentage of Patients
|
SECONDARY outcome
Timeframe: Month 12Population: ITT population, which consisted of all patients included in the study with Schirmer's testing data available at baseline. Data not reported due to limited number of patients with Schirmer's test data recorded.
Schirmer's test at month 12. The Schirmer's tear test is performed on the eye with or without anesthesia (numbing eye drop). The amount of tears produced by the eye in 5 minutes is measured in millimeters by means of a graduated paper scale. Data not reported due to limited number of patients with Schirmer's test data recorded.
Outcome measures
Outcome data not reported
Adverse Events
Patients Who Received Restasis®
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
- Publication restrictions are in place
Restriction type: OTHER