CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Instill Saline Drop +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT01128049
NCT01128049N/ACompleted

Non-invasive Tear Film Dynamic Measurements in Normal, MGD (Meibomium Gland Dysfunction) and Aqueous Deficient Dry Eye(ADDE) Subjects After Saline Instillation

University of Rochester·interventional·Posted May 21, 2010·Updated Aug 7, 2015

In Brief

A clinical study evaluating Subjective Questionnaire, Measurement with wavefront sensor (right eye, then left eye), and 1 other intervention for Aqueous Deficient Dry Eye and Meibomium Gland Dysfunction. Completed, enrolled 15 participants across 1 site.

Detailed Summary

Compare the objective tear film dynamic measurements in three different populations (MGD \[Meibomium Gland Dysfunction\], ADDE \[Aqueous Deficient Dry Eye\] and normal/control \[non-dry eye\]) and the subjective experience before and after instilling a single drop of saline in each eye. Currently available office-based tests for dry eye do not reliably correlate with patients' subjective symptoms. This study is interested in assessing how individuals with these two different ocular surface diseases compare with the normal population when measured objectively using two different instruments.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 21, 2010
Enrollment StartJun 1, 2010
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.1 years ago

Interventions

Subjective Questionnairebehavioral

The team will use a one page questionnaire to obtain subjective input before the first set of measurements and after instilling the Saline drop.

Measurement with wavefront sensor (right eye, then left eye)procedure

The wavefront instrument measures the eye's ability to create a sharp image by briefly shining a laser light from the wavefront sensor into the eye and measuring the light that bounces back through the cornea. For these measurements, subjects will sit on a chair and be instructed to place their chin in a chin rest and lean their forehead against a forehead rest. The subject will be instructed to hold his/her head steady, look in a certain direction, blink or not blink. We will obtain the measurements over a short period of up to approximately 45 seconds. We will start recording data asking the subject to either blink naturally or to hold his/her eye open for a few (up to 10) seconds, and repeat the blink and hold sequence usually for up to four times.

Instill Saline Dropdrug

One drop will be instilled in both eyes and patient will wait 5 minutes prior to repeating the questionnaire and wavefront sensor. A single drop is approximately 30 µL and will be placed into the inferior cul-de-sac while the patient looks up.