Trial Outcomes & Findings for Treatment of Ocular Graft-versus-Host Disease (GVHD) With Topical Loteprednol Etabonate 0.5% (NCT NCT01695668)

NCT ID: NCT01695668

Last Updated: 2015-09-24

Results Overview

Dry eye is one of the major symptoms of ocular GVHD in bone-marrow transplant recipients, worsening of dry eye symptoms may be indicative of worsening ocular GVHD conditions.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 75 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2015-09-24

Participant Flow

Participant milestones

Measure	Lotemax Loteprednol Etabonate 0.5%	Restasis Cyclosporine
Overall Study STARTED	38	37
Overall Study COMPLETED	23	20
Overall Study NOT COMPLETED	15	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Ocular Graft-versus-Host Disease (GVHD) With Topical Loteprednol Etabonate 0.5%

Baseline characteristics by cohort

Measure	Lotemax n=38 Participants Loteprednol Etabonate 0.5%	Restasis n=37 Participants Cyclosporine	Total n=75 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	32 Participants n=7 Participants	63 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Age, Continuous	54.06 years STANDARD_DEVIATION 13.68 • n=5 Participants	51.21 years STANDARD_DEVIATION 14.44 • n=7 Participants	52.64 years STANDARD_DEVIATION 14.06 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Dry eye is one of the major symptoms of ocular GVHD in bone-marrow transplant recipients, worsening of dry eye symptoms may be indicative of worsening ocular GVHD conditions.

Outcome measures

Measure	Lotemax n=38 Participants Loteprednol Etabonate 0.5%	Restasis n=37 Participants Cyclosporine
Progression of Dry Eye Severity	15 patients with increased dry eye severity	12 patients with increased dry eye severity

Adverse Events

Lotemax

Serious events: 9 serious events

Other events: 15 other events

Deaths: 0 deaths

Restasis

Serious events: 17 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lotemax n=38 participants at risk Loteprednol Etabonate 0.5% Lotemax	Restasis n=37 participants at risk Cyclosporine Restasis
Blood and lymphatic system disorders death	23.7% 9/38 • Number of events 9	45.9% 17/37 • Number of events 17

Other adverse events

Measure	Lotemax n=38 participants at risk Loteprednol Etabonate 0.5% Lotemax	Restasis n=37 participants at risk Cyclosporine Restasis
Eye disorders severe Dry eye	39.5% 15/38 • Number of events 15	32.4% 12/37 • Number of events 12

Additional Information

Dr Shahzad Mian

University of Michigan

Phone: 734-647-8397

Email: smian@med.umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place