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news.Inspire Pharmaceuticals has reported that its phase 3 clinical trial (Trial 03-113) of Prolacria (diquafosol tetrasodium ophthalmic solution) 2%, for the treatment of dry eye disease, did not meet its primary or secondary endpoints.
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The company said that the trial 03-113 was a six-week, randomised, placebo-controlled trial in 490 patients, who had a fluorescein staining score of three in the central region of the cornea at baseline, using the National Eye Institute scale of zero to three.
The primary endpoint was the proportion of subjects receiving Prolacria, administered four times daily as eye drops, that achieved clearing, or a staining score of zero, in the central region of the cornea in the study eye at the six-week trial endpoint, compared to those receiving placebo.
Whereas, the secondary endpoint was the proportion of patients receiving Prolacria that achieved greater than or equal to a two-unit reduction in staining scores at the six-week trial endpoint, compared to those receiving placebo.
Christy Shaffer, president and CEO of Inspire, said: “We have provided the top-line results from this trial to our partner Allergan and we will be conducting a thorough review of the program before determining next steps, if any.”