Evaporative Dry Eye — Safety and Effectiveness of EyePeace on Signs and Symptoms of Dry Eye Disease
Citation(s)
Butovich IA Lipidomics of human Meibomian gland secretions: Chemistry, biophysics, and physiological role of Meibomian lipids. Prog Lipid Res. 2011 Jul;50(3):278-301. doi: 10.1016/j.plipres.2011.03.003. Epub 2011 Mar 31.
Ma J, Pazo EE, Zou Z, Jin F Prevalence of symptomatic dry eye in breast cancer patients undergoing systemic adjuvant treatment: A cross-sectional study. Breast. 2020 Oct;53:164-171. doi: 10.1016/j.breast.2020.07.009. Epub 2020 Aug 5.
McMonnies CW Management of chronic habits of abnormal eye rubbing. Cont Lens Anterior Eye. 2008 Apr;31(2):95-102. doi: 10.1016/j.clae.2007.07.008. Epub 2008 Mar 19.
Olson MC, Korb DR, Greiner JV Increase in tear film lipid layer thickness following treatment with warm compresses in patients with meibomian gland dysfunction. Eye Contact Lens. 2003 Apr;29(2):96-9. doi: 10.1097/01.ICL.0000060998.20142.8D.
Tichenor AA, Cox SM, Ziemanski JF, Ngo W, Karpecki PM, Nichols KK, Nichols JJ Effect of the Bruder moist heat eye compress on contact lens discomfort in contact lens wearers: An open-label randomized clinical trial. Cont Lens Anterior Eye. 2019 Dec;42(6):625-632. doi: 10.1016/j.clae.2019.09.005. Epub 2019 Oct 3.
Wang MTM, Feng J, Wong J, Turnbull PR, Craig JP Randomised trial of the clinical utility of an eyelid massage device for the management of meibomian gland dysfunction. Cont Lens Anterior Eye. 2019 Dec;42(6):620-624. doi: 10.1016/j.clae.2019.07.008. Epub 2019 Jul 26.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
