Improvements in Signs and Symptoms of Dry Eye with MIM-D3 1% Ophthalmic Solution Compared to Placebo in Different Patient Populations

Abstract

Purpose: Ocular comorbidities are potentially important etiological factors in understanding dry eye and its treatment modalities. To explore the clinical efficacy of MIM-D3 1% Ophthalmic Solution compared to placebo in signs and symptoms of dry eye in patients with cataracts or normal lens.

Methods: A multi-center, randomized, double masked, placebo controlled study included a 7-day run-in period and 56 days of twice daily (BID) dosing. For screening purposes, at Visits 1 and 2, patients were exposed to the Controlled Adverse Environment (CAE^SM) chamber. Patients were dosed BID with artificial tears between Visits 1 and 2. Eligible patients had sufficient fluorescein corneal (FCS) and lissamine green staining, tear film break up time ≤5 seconds, and symptoms at both visits and in patient recorded diaries during the run-in period. Additionally, patients demonstrated an exacerbation of FCS and ocular discomfort after exposure to the CAE^SM. Patients were randomized 1:1 to MIM-D3 1% or placebo. A post-hoc analysis was based on ocular medical history. Two subgroups were defined based on slit lamp examination of lens, one for cataract (both pre- and post-surgery) another for normal lens.

Results: In the intent to treat population (n=403, mean age 58.8 years), MIM-D3 1% showed significantly less FCS (change from pre- to post-CAE^SM) compared to placebo after 56 days of treatment (p=0.050). Improvements were also observed in ocular discomfort symptom and the ocular surface diseases index (OSDI^©) questionnaire with MIM-D3 compared to placebo. A dramatic difference in response to treatment with MIM-D3 was observed in a subgroup of patients with cataracts compared to patients without lenticular opacities. Patients with cataracts were observed to have significantly improved treatment differences in FCS (p=0.036) and OSDI^© (p=0.049). Whereas, patients with normal lens showed significant improvement (p=0.005) in ocular discomfort symptom scores in MIM-D3 treated patients compared to placebo.

Conclusions: Topical ophthalmic MIM-D3 demonstrated improvements in signs and symptoms in patients with dry eye. These post-hoc data adjusting for ocular comorbidities show that specific patient populations respond to MIM-D3 for reduction of signs and others for symptoms.