Trial Outcomes & Findings for The Prophylactic Use of Topical Cyclosporine A 0.05% to Prevent Graft Versus Host Disease Related Dry Eye (NCT NCT00553735)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

8 participants

Primary outcome timeframe

18 months

Results posted on

2017-03-28

Participant Flow

Participant milestones

Participant milestones
Measure	All Study Participants Each eye of every participant was randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive placebo (Artificial Tear) The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score. Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.
Overall Study STARTED	8
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Prophylactic Use of Topical Cyclosporine A 0.05% to Prevent Graft Versus Host Disease Related Dry Eye

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=8 Participants The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score. Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	43 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Population: No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 18 Months

Population: No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 18 Months

Population: All patients enrolled in the study were analyzed.

Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.

Outcome measures

Outcome measures
Measure	Cyclosporine A 0.05% n=8 Participants If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear) The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score. Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.	Artificial Tear n=8 Participants If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear) The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score. Arificial Tear: Artificial Tear - three times a day for 18 months.
Incidence and Severity of Ocular Adverse Event	2 participants	2 participants

SECONDARY outcome

Timeframe: 18 Months

Population: No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 Months

Population: No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 Months

Population: No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 Months

Population: No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.

Outcome measures

Outcome data not reported

Adverse Events

Arm I

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm I n=8 participants at risk The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score. Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.
Eye disorders Uveitis (bilateral)	12.5% 1/8 • Number of events 1 The adverse events reported are by "eye". Two adverse events were reported: uveitis and bacterial infection. Both these events were bilateral (i.e. both eyes), occurring in two separate subjects.
Eye disorders Bacterial Infection (bilateral)	12.5% 1/8 • Number of events 1 The adverse events reported are by "eye". Two adverse events were reported: uveitis and bacterial infection. Both these events were bilateral (i.e. both eyes), occurring in two separate subjects.

Additional Information

Reza Dana, MD, MPH, MSc

Massachusetts Eye and Ear Infirmary

Phone: 617-573-3313

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place