A Study of ALTY-0501 for the Treatment of Dry Eye Administered 4 Times a Day for a 56 Day Period
The objective of this study is to assess the safety and efficacy of doxycycline 0.025% (ALTY-0501) ophthalmic solution for the treatment of dry eye using the Controlled Adverse Environment (CAE) Model.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
|Official Title:||A Double-Masked, Randomized, Placebo-Controlled Study of ALTY-0501 (Doxycycline 0.025% Ophthalmic Solution) for the Treatment of Dry Eye Administered QID for a 56 Day Period Utilizing the Controlled Adverse Environment Model|
|Study Start Date:||February 2007|
|Study Completion Date:||August 2007|
|Active Comparator: A||Drug: doxycycline|
|Placebo Comparator: B||Drug: placebo|
Dry eye is the most prevalent form of ocular discomfort and irritation. Estimates range up to 20 million people in the US being affected with mild dry eye, and the literature reports that as many as 3.2 million American women suffer from clinically significant dry eye.(Schaumberg et al, 2003). Dry eye can be related to external factors, such as the low humidity of air conditioned offices, winter heating, a dusty or windy outdoor environment, prolonged use of computers, or wearing of contact lenses, as well as to internal factors, such as hormonal imbalance, autoimmune disease, the presence of many widely prescribed systemic medications, anatomical changes or trauma, and aging. Chronic dry eye disease is associated with an immune-based inflammation of the lacrimal glands and the ocular surface. Symptoms result in mildly decreased quality of life at a minimum, and with increasing severity, loss of function and productivity, pain, light sensitivity, and the misery that accompanies significantly impaired vision and decreased quality of life. With the aging population in the United States and other countries of the developed world, and with increasing computer use, dry eye will become more prevalent.
Doxycycline is a well established anti-infective drug, and has been used systemically by ophthalmologists to treat moderate to severe case of blepharitis for years. Recently it has been demonstrated that doxycycline in low, non-antimicrobial concentrations also has powerful anti-proteolytic and anti-inflammatory properties. Anecdotal reports on the use of 0.025% doxycyline eyedrops in human patients with dry eye and/or meibomian gland disease indicate a significant improvement in ocular surface staining and a significant decrease in patient symptoms.