One strip moistened with 1 or 2 drops of sterile irrigating or saline solution, touched to the conjunctiva or fornix, followed by several blinks
OFF-LABELNot in the FDA label for this product
Tear breakup time for dry eye
One saline-moistened strip touched to the conjunctiva or fornix, then time the first break in the tear film; hold the moistening solution and volume constant and average several readings
Diagnostic · n=46 · technique
In a randomized comparison of three instillation methods in 46 subjects, a standard moistened strip gave an area under the curve of 0.912 with a 3.42 second cut-point (sensitivity 0.97, specificity 0.80) and differed little from micropipetted dye, though the authors put the optimum cut-point at 5.3 to 6.0 seconds when measured liquid volumes were used. Technique moves the number: strips deliver less than 1 microliter with a wider range than a pipette, raising instilled volume from 1 to 2.7 microliters lengthens the measured time (P<0.001), and six common moistening solutions gave significantly different values in 58 subjects, only the two saline solutions being indistinguishable from each other.
Fluorescein dye disappearance test for lacrimal outflow obstruction
One drop of fluorescein solution to the inferior fornix of each eye, residual tear film dye graded at 5 minutes
Diagnostic · n=80 · not strip
Prospective evaluation of lacrimal outflow obstruction in infants: 90% sensitive and 100% specific across 80 lacrimal systems in the preliminary study, and abnormal in 237 of 288 eyes of children presenting with epiphora in the main study. A retrospective series of 176 eyes after dacryocystorhinostomy found the 5 minute test 100% sensitive and 86.3% specific in assessing anatomical success, every anatomically failed case showing a positive test; both series instilled dye solution rather than a strip.
The labeling for this unapproved drug states no condition under which the strips must not be used
It states only that they are for external use only and that contents may not be sterile if individual strips have been damaged or previously opened
Available Forms
Fluorescein sodium impregnated paper strips, dispenser carton of 100 or 300 strips
Mechanism of Action
Water soluble dye that is excluded by an intact epithelial barrier and fluoresces green under cobalt blue excitation, disclosing epithelial defects and outlining the tear film. Impression cytology and confocal microscopy trace punctate staining to individual superficial epithelial cells with enhanced fluorescence rather than to dye pooling in erosions alone.
Warnings & Precautions
Solution contamination: Fluorescein supports bacterial growth. All 21 in-use multiple-use bottles of fluorescein solution sampled from eye clinics grew organisms, most often Pseudomonas spp., while 18 unopened bottles were sterile; a strip removes that reservoir and leaves the moistening solution and the strip tip as the points of contact.
Soft contact lens staining: Dye is absorbed into the hydrogel matrix in proportion to exposure time and varies with lens power and water content, so soft lenses come out before instillation; rinse with 0.9% saline rather than an oxidizing agent, since 3% hydrogen peroxide decolorizes retained dye without removing it.
Common Side Effects
The labeling for this unapproved drug has no adverse effects section, so it reports no side effects for the strips.
Pregnancy & Lactation
Limited data; potential risks to the fetus not well established
GoodRx
Available Forms
Mechanism of Action
Pregnancy & Lactation
Pediatric Use