Trial Outcomes & Findings for Non-invasive Tear Film Dynamic Measurements in Normal, MGD and ADDE Subjects After Saline Instillation (NCT NCT01128049)

Results Overview

Average visual quality change over a 5 second blink cycle caused by movement of the tears over the surface of the eye by measuring optical irregularities.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

5 seconds

Results posted on

2015-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Normal Patient Population Subjects with no symptoms and no diagnosis of dry eye. Schirmer's value ≥ 10mm/5 mins and a fluorescein tear break-up time \>5 secs with no surface staining.	MGD Patient Population Subjects with a meibomian gland dysfunction on a slitlamp examination with a fluorescein tear break-up time \<5 secs.	ADDE Population Subjects with schirmer's value \< 10mm/5 mins and no meibomian gland dysfunction.
Overall Study STARTED	5	5	5
Overall Study COMPLETED	5	5	5
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Non-invasive Tear Film Dynamic Measurements in Normal, MGD and ADDE Subjects After Saline Instillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normal Patient Population n=5 Participants Subjects with no symptoms and no diagnosis of dry eye. Schirmer's value ≥ 10mm/5 mins and a fluorescein tear break-up time \>5 secs with no surface staining.	MGD Patient Population n=5 Participants Subjects with a meibomian gland dysfunction on a slitlamp examination with a fluorescein tear break-up time \<5 secs.	ADDE Population n=5 Participants Subjects with schirmer's value \< 10mm/5 mins and no meibomian gland dysfunction.	Total n=15 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants	15 participants n=4 Participants

PRIMARY outcome

Timeframe: 5 seconds

Population: The comparison was between normal, non-dry eye participants and dry eye groups.

Average visual quality change over a 5 second blink cycle caused by movement of the tears over the surface of the eye by measuring optical irregularities.

Outcome measures

Outcome measures
Measure	Normal n=5 Participants Normal group included non-dry eye subjects.	Meibomian Gland Dysfunction (MGD) n=5 Participants Subjects with mild to moderate Meibomian Gland Dysfunction (MGD) on a slit lamp examination were included in this group.	Aqueous Deficiency Dry Eye (ADDE) n=5 Participants Subjects with a low tear volume measured by Schimer's score of less than 10 mm were included in this group.
Visual Quality Visual Quality at Baseline	0.3 microns Standard Deviation 0.07	0.32 microns Standard Deviation 0.08	0.19 microns Standard Deviation 0.06
Visual Quality Visual Quality at 5 minutes after Saline	0.3 microns Standard Deviation 0.08	0.33 microns Standard Deviation 0.08	0.23 microns Standard Deviation 0.05

Adverse Events

Normal Patient Population

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MGD Patient Population

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ADDE Population

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

James Aquavella, MD

University of Rochester Medical Center, Flaum Eye Institute

Phone: 585-275-8944

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor review required before publishing results.
Publication restrictions are in place

Restriction type: OTHER