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Peter A Simmons, Haixia Liu, Joseph Glennon Vehige, Cindy Carlisle, Ru Chen, Genming Shi; TREATMENT RESPONSE IN A CLINICAL TRIAL FOR DRY EYE VARIES WITH ENTERING LEVEL OF SIGNS AND SYMPTOMS. Invest. Ophthalmol. Vis. Sci. 2014;55(13):3674.
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It is commonly reported that signs and symptoms in dry eye do not correlate with each other. In this large, multi-center, randomized clinical trial, we performed a series of secondary analyses of the data to explore whether different subgroups of patients at entry responded differently to an advanced artificial tear vs a standard formula.
Clinical efficacy and safety of a new artificial tear formula (Optive Fusion, Allergan) was compared to a standard tear (Refresh Tears, Allergan), in which a total of 101 and 104 subjects (respectively) exhibiting signs and symptoms of dry eye were enrolled into a randomized multi-center trial with 90 days of dosing at least twice a day. In addition to the whole population, 8 subgroups were analyzed for treatment response based upon entering characteristics: OSDI total score >23 (moderate/severe), OSDI total score >33 (severe), OSDI Ocular Symptoms >25 (moderate/severe), OSDI Ocular Symptoms >41 (severe), VAS dryness scale >48 (moderate/severe), VAS dryness scale >66 (severe), combined corneal/conjunctival staining >6 (moderate/severe), staining >15 (severe).
Both tears produced statistically significant improvement from baseline in ocular surface staining and symptoms of dry eye (OSDI and VAS scores), but the difference in response varied by subgroup. Overall OSDI score improvement was not different between treatments for any of the subgroups. However, the OSDI Ocular Symptoms subscale improved more for the new formula (p<0.05) for most subgroups, particularly those exhibiting higher levels of staining at baseline. VAS dryness showed a greater difference in favor of the new formula for the moderate/severe subgroups, and less difference for the severe only subgroups. For combined staining, all subgroups showed a greater improvement with the new formula at one or more study visits, with greater differentiation for the more severe subgroups (p<0.05).
In this heterogeneous dry eye population, patients with varying baseline levels of symptoms and signs responded differently. The more advanced artificial tear formula showed improved performance particularly in ocular surface staining, and more so for more severe patients. These results are also helpful in selection of entry criteria and outcome variables to optimize clinical trial design.
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