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M. T. Christensen, W. F. Davitt, M. Bloomenstein, A. E. Martin; An Evaluation of Efficacy Between Two Marketed Artificial Tears Tested Under Environmental Conditions. Invest. Ophthalmol. Vis. Sci. 2009;50(13):4645.
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To evaluate efficacy of a PEG/PG based lubricant eye drop vs a glycerin/CMC based tear under arid environmental conditions.
This was a double masked, randomized, parallel study design of 42 days duration. 105 patients were evaluable for intent-to-treat. Patients had to have ≥ 3 sum of corneal stain (NEI grid; Max 15 pts) and had to answer that they needed artificial tears at least "some of the time" to be enrolled. The PEG/PG (Systane® Ultra) Lubricant Eye Drops (Alcon) is a multi-dose formulation stored at pH 7.9 in the bottle. HP-Guar is the gelling agent which helps hold the active demulcents onto the eye, allowing for healing. The glycerin/CMC based tear (OPTIVE; Allergan, Inc) was used as the control. To reduce the placebo effect, study patients used a saline drop QID for 14 days prior to randomization on treatment. Patients were told to use their assigned drops QID for the duration of the six week study. Corneal and conjunctival staining was evaluated at each visit. Symptoms were evaluated using a Treatment Satisfaction Questionnaire and VF-14 Questionnaire.
A significant difference in corneal staining mean score favoring the PEG/PG relative to the glycerin/CMC drop was found overall (p=0.0172) and at days 14 (p=0.0009) and at day 42 (p=0.0106). There was also a significant difference in conjunctival staining favoring the PEG/PG drop noted at day 28 (p=0.0475) and day 42 (p=0.0009) and overall (p=0.0268). There were no significant differences between treatments for symptoms as tested by the Treatment Satisfaction Questionnaire and VF-14 Questionnaire. Finally, no difference in TFBUT was seen.
These studies showed that the PEG/PG based lubricant eye drop demonstrated statistically significant reductions in both corneal and conjunctival staining vs the glycerin/CMC drop. Symptoms were similar between test arms. This study demonstrates superior stain reduction of the PEG/PG lubricant eye drop over a 6 week period.
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