Trial Outcomes & Findings for Bandage Lenses in Treating Patients With Ocular Graft-Versus-Host Disease (NCT NCT01616056)

NCT ID: NCT01616056

Last Updated: 2017-07-17

Results Overview

Lee eye subscale: sx6 dry eyes, sx7 need to use eye drops frequently, sx8 difficulty seeing clearly 0=not at all, 4=extremely bothered. If have at least one of (sx6,sx7,sx8), then sx\_eye=mean(sx6,sx7,sx8)\*25. Minimum possible score: 0 correlated with better outcome, maximum score possible: 100 correlated with worse outcome. Clinically meaningful change is half a standard deviation, which is a decrease of 11.8 of more for this scale.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2017-07-17

Participant Flow

Participant milestones

Measure	Bandage Contact Lenses Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bandage Lenses in Treating Patients With Ocular Graft-Versus-Host Disease

Baseline characteristics by cohort

Measure	Bandage Contact Lenses n=19 Participants Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Age, Continuous	55 years n=93 Participants
Sex: Female, Male Female	8 Participants n=93 Participants
Sex: Female, Male Male	11 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	15 Participants n=93 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: 3 months

Lee eye subscale: sx6 dry eyes, sx7 need to use eye drops frequently, sx8 difficulty seeing clearly 0=not at all, 4=extremely bothered. If have at least one of (sx6,sx7,sx8), then sx_eye=mean(sx6,sx7,sx8)*25. Minimum possible score: 0 correlated with better outcome, maximum score possible: 100 correlated with worse outcome. Clinically meaningful change is half a standard deviation, which is a decrease of 11.8 of more for this scale.

Outcome measures

Measure	Bandage Contact Lenses n=19 Participants Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale Baseline	75.4 units on a scale Standard Deviation 4.25
Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale 2 weeks	63.2 units on a scale Standard Deviation 4.82
Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale 4 weeks	61.8 units on a scale Standard Deviation 4.52
Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale 3 months	56.3 units on a scale Standard Deviation 7.28

PRIMARY outcome

Timeframe: 3 months

8-level change score is from 0 completely gone to 7 very much worse. Clinically meaningful improvement is defined as half a standard deviation (decreased score of 11.8 or greater).

Outcome measures

Measure	Bandage Contact Lenses n=19 Participants Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale 2 weeks	9 Participants
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale 4 weeks	11 Participants
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale 3 months	9 Participants

PRIMARY outcome

Timeframe: 3 months

OSDI minimum score: 0, correlated with better outcome, maximum score: 100, correlated with worse outcome. 12 questions 0 none of the time to 4 all of the time. (Sum of scores)x25/number of questions answered. Clinically meaningful change scores are half a standard deviation, which is 10.9 for the OSDI.

Outcome measures

Measure	Bandage Contact Lenses n=19 Participants Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index Baseline	54.5 units on a scale Standard Deviation 6.19
Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index 2 weeks	36.8 units on a scale Standard Deviation 5.32
Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index 4 weeks	32.9 units on a scale Standard Deviation 5.74
Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index 3 months	35.6 units on a scale Standard Deviation 6.50

PRIMARY outcome

Timeframe: 3 months

OSDI minimum score: 0, correlated with better outcome, maximum score: 100, correlated with worse outcome. 12 questions 0 none of the time to 4 all of the time. (Sum of scores)x25/number of questions answered. Clinically meaningful change scores are half a standard deviation, which is 10.9 for the OSDI.

Outcome measures

Measure	Bandage Contact Lenses n=19 Participants Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI 2 weeks	10 Participants
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI 4 weeks	13 Participants
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI 3 months	10 Participants

PRIMARY outcome

Timeframe: 3 months

The 11-point eye scale goes from 0 not present to 10 as bad as you can imagine. Clinically meaningful change is defined as a 2 point or more decrease.

Outcome measures

Measure	Bandage Contact Lenses n=19 Participants Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale 3 months	3.94 units on a scale Standard Deviation 0.59
Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale Baseline	7.11 units on a scale Standard Deviation 0.42
Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale 2 weeks	5.00 units on a scale Standard Deviation 0.56
Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale 4 weeks	4.37 units on a scale Standard Deviation 0.45

PRIMARY outcome

Timeframe: 3 months

The 11-point eye scale goes from 0 not present to 10 as bad as you can imagine. Clinically meaningful change is defined as a 2 point or more decrease.

Outcome measures

Measure	Bandage Contact Lenses n=19 Participants Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale 2 weeks	11 Participants
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale 4 weeks	13 Participants
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale 3 months	12 Participants

SECONDARY outcome

Timeframe: 1 month

Safety of Bandage Contact Lenses at 1 month

Outcome measures

Measure	Bandage Contact Lenses n=19 Participants Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Number of Patients Who Experienced Serious Adverse Events	0 Participants

SECONDARY outcome

Timeframe: 2 weeks

Population: Ophthalmology assessments made after 2 weeks were not analyzed because of incomplete data collection.

LogMAR visual acuity score of 0 is equivalent to 20/20 vision. Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.

Outcome measures

Measure	Bandage Contact Lenses n=19 Participants Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Change in Comprehensive Ophthalmologic Evaluations logMAR visual acuity baseline	0.26 logMAR Standard Deviation 0.030
Change in Comprehensive Ophthalmologic Evaluations logMAR visual acuity 2 weeks	0.15 logMAR Standard Deviation 0.030

SECONDARY outcome

Timeframe: 2 weeks

Population: Optical coherence tomography results were not analyzed because of incomplete data collection.

Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.

Outcome measures

Outcome data not reported

Adverse Events

Bandage Contact Lenses

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bandage Contact Lenses n=19 participants at risk Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Eye disorders Foreign body sensation	73.7% 14/19 • Number of events 14 • 3 months
Eye disorders Swollen eye lids	26.3% 5/19 • Number of events 5 • 3 months
Eye disorders Excessive tearing	10.5% 2/19 • Number of events 2 • 3 months
Eye disorders Corneal edema and stromal haze	5.3% 1/19 • Number of events 1 • 3 months

Additional Information

Stephanie J. Lee MD MPH

FHCRC

Phone: 206-667-6190

Email: sjlee@fhcrc.org

Results disclosure agreements

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