Trial Outcomes & Findings for Impairment of Reading Ability in Dry Eye Patients (NCT NCT01826812)

NCT ID: NCT01826812

Last Updated: 2018-02-15

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 200 participants
• Primary outcome timeframe: 30 minutes
• Results posted on: 2018-02-15

Participant Flow

Ocular staining score (OSS) is sum of the corneal and conjuctival staining scores with a total possible maximum score of 12 for each eye. Corneal staining is graded with a maximum possible fluorescein score of 6 for each eye. Nasal and temporal conjunctiva are graded separately with a lissamine green staining score between 0 and 3 for each area.

Participant milestones

Measure	Dry Eye Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more	Controls Controls defined as OSDI 12 and less AND total OSS score less than 3
Overall Study STARTED	167	33
Overall Study COMPLETED	167	32
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impairment of Reading Ability in Dry Eye Patients

Baseline characteristics by cohort

Measure	Dry Eye n=167 Participants Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more	Controls n=33 Participants Controls defined as OSDI 12 and less AND total OSS score less than 3	Total n=200 Participants Total of all reporting groups
Age, Continuous	64.1 years STANDARD_DEVIATION 8.7 • n=5 Participants	61.4 years STANDARD_DEVIATION 8.7 • n=7 Participants	63.7 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	122 Participants n=5 Participants	19 Participants n=7 Participants	141 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	14 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	160 Participants n=5 Participants	32 Participants n=7 Participants	192 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	6 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) White	139 Participants n=5 Participants	24 Participants n=7 Participants	163 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	167 participants n=5 Participants	33 participants n=7 Participants	200 participants n=5 Participants
Baseline Visual Acuity, logMAR	-0.04 logMAR STANDARD_DEVIATION 0.11 • n=5 Participants	-0.03 logMAR STANDARD_DEVIATION 0.10 • n=7 Participants	-0.038 logMAR STANDARD_DEVIATION 0.11 • n=5 Participants
Baseline Osmolarity	312 mOsm/L STANDARD_DEVIATION 28 • n=5 Participants	306 mOsm/L STANDARD_DEVIATION 10 • n=7 Participants	311 mOsm/L STANDARD_DEVIATION 26 • n=5 Participants
Baseline total OSS score	4.9 scores on a scale of 0 to 12 STANDARD_DEVIATION 3.3 • n=5 Participants	0.9 scores on a scale of 0 to 12 STANDARD_DEVIATION 0.9 • n=7 Participants	4.3 scores on a scale of 0 to 12 STANDARD_DEVIATION 3.4 • n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes

Outcome measures

Measure	Dry Eye n=167 Participants Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more	Controls n=32 Participants Controls defined as OSDI 12 and less AND total OSS score less than 3
Sustained Silent Reading Speed	248.4 words/minute Standard Deviation 79.5	270.3 words/minute Standard Deviation 75.3

SECONDARY outcome

Timeframe: Before and after 30 minutes reading

Ocular staining score (OSS) is sum of the corneal and conjuctival staining scores with a total possible maximum score of 12 for each eye. Corneal staining is graded with a maximum possible fluorescein score of 6 for each cornea (the punctate epithelial erosions grade between 0-3 plus any extra points for modifiers up to 3). Nasal and temporal conjunctiva are graded separately with a score range between 0 and 3 for each area after instillation of lissamine green. An abnormal OSS is defined as being a total score of 3 or more.

Outcome measures

Measure	Dry Eye n=167 Participants Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more	Controls n=32 Participants Controls defined as OSDI 12 and less AND total OSS score less than 3
Change in Total Ocular Staining Score (OSS)	1.5 units on a scale Standard Deviation 1.4	1.1 units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Before and after 30 minutes reading

Outcome measures

Measure	Dry Eye n=167 Participants Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more	Controls n=32 Participants Controls defined as OSDI 12 and less AND total OSS score less than 3
Change in Tear Osmolarity	2.7 mOsm/L Standard Deviation 12.3	1.8 mOsm/L Standard Deviation 10.9

SECONDARY outcome

Timeframe: 30 minutes

Outcome measures

Measure	Dry Eye n=167 Participants Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more	Controls n=32 Participants Controls defined as OSDI 12 and less AND total OSS score less than 3
Change in Visual Acuity	0.02 logMAR Standard Deviation 0.07	0.02 logMAR Standard Deviation 0.09

SECONDARY outcome

Timeframe: Tear samples were collected on the day of the exam. The samples were frozen to be assayed upon completion of the study.

Population: The cytokine analysis was performed in the samples of selected participants based on their clinical signs and characteristics. The sample size of the groups was justified using the power analysis.

Identification of various inflammatory cytokines in tear film of dry eye patients comparing to controls.

Outcome measures

Measure	Dry Eye n=42 Participants Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more	Controls n=21 Participants Controls defined as OSDI 12 and less AND total OSS score less than 3
Cytokines IFNg	99.79 pg/mL Standard Error 16.81	150.10 pg/mL Standard Error 30.29
Cytokines TNFa	131.16 pg/mL Standard Error 54.63	107.53 pg/mL Standard Error 25.30
Cytokines IL6	130.78 pg/mL Standard Error 39.65	69.64 pg/mL Standard Error 13.40
Cytokines IL17A	176.08 pg/mL Standard Error 28.39	200.00 pg/mL Standard Error 41.42
Cytokines IL1b	27.40 pg/mL Standard Error 5.09	27.87 pg/mL Standard Error 6.47
Cytokines IL8	903.91 pg/mL Standard Error 268.02	157.58 pg/mL Standard Error 32.39
Cytokines IL10	211.69 pg/mL Standard Error 30.37	304.29 pg/mL Standard Error 55.01
Cytokines IL12p70	70.89 pg/mL Standard Error 10.06	131.32 pg/mL Standard Error 28.59

Adverse Events

Dry Eye

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Esen K. Akpek

The Wilmer Eye Institute, Johns Hopkins

Phone: 410-955-5214

Email: esakpek@jhmi.edu

Results disclosure agreements

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