Pilot Study of TearCare System - Long-Term Extension

The TBUT was evaluated by measuring the time to breakup of the tear film following a complete blink when viewed through the slit-lamp using a cobalt blue filter. The TBUT was recorded using a stopwatch for each eye as the average of 3 measurements at each visit. The change in TBUT was The difference between the mean baseline value and the mean Month 1 value. The TBUT for each eye for a subject was averaged resulting in a single TBUT value for each subject (n=12).

Using a Korb Meibomian Gland Evaluator (TearScience), the meibomian gland assessment was conducted by evaluating the consistency of the secretions that were observed upon expression of meibomian glands in the nasal, central, and temporal regions of the lower eyelids. The central, consecutive 5 glands in each region were evaluated. The instrument was held at the eyelid margin for 10-15 seconds, and the secretions were graded on a 0-3 scale for each gland (0=no expression; 1=toothpaste; 2=cloudy; and 3=clear), with a 0 (worst)-45 (best) score range for each eye. The score for each eye of a subject was averaged. The change from baseline in the Meibomian Gland Score is the difference between the mean baseline value and the mean value at Month 1. A positive value for change is an improvement

The Standard Patient Evaluation for Eye Dryness II (SPEED II) questionnaire is a well-validated instrument and widely used assessment tool for dry eye indications. The SPEED II questionnaire was used to evaluate the symptoms of study subjects. The SPEED II survey measures the severity (0-4 scale) and frequency (0-3 scale) of DED symptoms. The SPEED score was calculated by adding the total of the frequency and severity scores; a score of greater than or equal to 6 may be an indicator of DED (range 0 [best] to 7 [worst]). The reported value is the mean of the change for all subjects. A negative result indicates improvement.

The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire that assesses symptoms of ocular irritation associated with dry eye and the impact of these on vision-related activities. The OSDI score ranges from 0 (best possible) to 100 (worst possible). The change in OSDI questionnaire from baseline to Month 1 is the difference between the scores at the two timepoints. A negative value would indicate improvement and a positive value, a worsening. The reported value is the mean of the change for all subjects.

Corneal (fluorescein) staining scores was recorded to assess the integrity of the ocular surface. The severity of staining was assessed and quantified using the National Eye Institute/Industry Grading System scoring 5 regions of the cornea using a scale from 0 to 3 (normal-severe) for each region. The scores for the regions of the cornea were added to obtain a total score that ranged from 0 (best) to 15 (worst). The score for each eye of a subject was averaged. The mean change from baseline to month 1 is the difference in the two scores. A negative result indicates improvement.

Conjunctival (lissamine green) staining scores was recorded to assess the integrity of the ocular surface. The severity of staining was assessed and quantified using the National Eye Institute/Industry Grading System scoring 6 regions of the conjunctiva using a scale from 0 to 3 (normal-severe) for each region. The scores for the regions of the conjunctiva were added to obtain a total score that ranged from 0 (best) to 18 (worst). The score for each eye of a subject was averaged. The mean change from baseline to month 1 is the difference in the two scores. A negative result indicates improvement.

The SANDE (Symptom Assessment iN Dry Eye) instrument is a simple 2-item questionnaire, that focuses on the frequency and the severity of dry eye symptoms with each measured along a visual analog scale. SANDE, because of its simplicity, is often used in routine clinical practice. For the core questions, the frequency and severity scores are multiplied together, and the square root is taken to produce an overall SANDE score from 0 (best possible) to 100 (worst possible). The mean change from baseline to month 1 is the difference in the two scores. A negative result indicates improvement.