ALTY-0501 is basically a very low dose topical doxycycline aimed at "preventing the disruption of the epithelial barrier on the ocular surface".
Study design sounded kind of interesting:
The Phase 2 study utilized the controlled adverse environment (CAE) chamber to measure dry eye patients' ability to withstand a stressful drying environment on the eye, and patient diaries to measure the severity of their dry eye symptoms over the course of the study. Patients were randomized to receive ALTY-0501 or its vehicle four times each day over the course of a 56 day study.
Like all dry eye testing they seek to demonstrate improvement in both signs and symptoms. In this case, "signs" were exclusively staining (numbers for total, superior and nasal were reported), and "symptoms" of burning, stinging and grittiness were somehow gleaned from patient diaries (sure would like to know how that was structured!).
Alacrity are hoping to move forward with Phase III clinicals in early 2008.
2 comments:
Hi Rebecca - Good news - and somewhat related - will you be updating the Clinical Trials link on the site? I really love that page -
Cheers
Hi there - yes, I will! Just trying to deal with a software glitch that has left me unable to edit the websites for a coupla weeks. I will try and get the whole Clinical Trials section updated within the next couple of days. Thanks for your interest! - Rebecca
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