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Karen Meerovitch, Teresa Lama, Debra Schaumberg; Relating Improvements in Signs and Symptoms to Duration of Dry Eye Disease (DED) after Treatment with MIM-D3 Ophthalmic Solutions. Invest. Ophthalmol. Vis. Sci. 2013;54(15):4340.
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To explore the clinical outcomes of signs and symptoms after 28 days of treatment with 1% and 5% MIM-D3 ophthalmic solutions as a function of patient reported duration of DED.
A 2-center, randomized, double-masked, placebo-controlled Phase 2 study was conducted in 150 dry eye patients. Key eligibility criteria included OraCalibra™ scores of ≥ 4, ≥ 2 and ≥ 2 for fluorescein corneal staining (FCS), lissamine green staining, and one symptom from the 4-Symptom Questionnaire, respectively. Additionally, patients had to demonstrate an exacerbation of FCS and ocular discomfort after exposure to a Controlled Adverse Environment (CAESM) on 2 visits, separated by 1-week of BID dosing with artificial tears. Eligible patients were assigned 1:1:1 to study medications (1% MIM-D3, 5% MIM-D3, placebo) and dosed BID for 28 days. Patients recorded morning and evening symptoms in daily diaries. Efficacy measures were FCS post-CAE at Day 28 and patient diary data over the 28-day treatment period. A post-hoc analysis based on duration of DED was performed. Subgroups were created based on the length of time that the patient had reported experiencing dry eye symptoms: 1-5 years, 5-10 years, or >10 years. FCS post-CAE and diary data were evaluated in these subgroups.
Patients who reported having DED for 5-10 years experienced a significant reduction in inferior and total FCS post-CAE, whereas no significant improvements were observed in the patients who reported having DED for 1-5 years or >10 years. The post-CAE staining scores were significantly lower in the 1% MIM-D3 group in inferior (P=0.028) and total cornea (P=0.047) compared to placebo. Patients who reported having DED for 5-10 years also experienced significant improvements for ocular dryness (P=0.029) and grittiness (P=0.035) symptoms in the 1% MIM-D3 group compared to placebo.
These post-hoc data support an association between the duration of DED and the response to MIM-D3 for the reduction in both signs and symptoms. Adjusting for disease duration, patients with reported DED for 5-10 years had a significant treatment effect with 1% MIM-D3 in reducing both FCS and diary symptoms of dryness and grittiness.
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