NCT03519815 - Clinical Trial References

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.

Citation(s)

Craig JP, Nelson JD, Azar DT, Belmonte C, Bron AJ, Chauhan SK, de Paiva CS, Gomes JAP, Hammitt KM, Jones L, Nichols JJ, Nichols KK, Novack GD, Stapleton FJ, Willcox MDP, Wolffsohn JS, Sullivan DA
TFOS DEWS II Report Executive Summary. Ocul Surf. 2017 Oct
Craig JP, Purslow C, Murphy PJ, Wolffsohn JS
Effect of a liposomal spray on the pre-ocular tear film. Cont Lens Anterior Eye. 2010 Apr;33(2):83-7. doi: 10.1016/j.clae.2009.12.007. Epub 2010 Jan 21.
Dausch D, Lee S, Dausch S, Kim JC, Schwert G, Michelson W
[Comparative study of treatment of the dry eye syndrome due to disturbances of the tear film lipid layer with lipid-containing tear substitutes]. Klin Monbl Augenheilkd. 2006 Dec;223(12):974-83. G
Khaireddin R, Schmidt KG
[Comparative investigation of treatments for evaporative dry eye]. Klin Monbl Augenheilkd. 2010 Feb;227(2):128-34. doi: 10.1055/s-0028-1109686. Epub 2009 Sep 15. German.
Lee S, Dausch S, Maierhofer G, Dausch D
[A new therapy concept for the treatment of dry eye--the usefulness of phospholipid liposomes]. Klin Monbl Augenheilkd. 2004 Oct;221(10):825-36. German.

Prospective Randomized Study to Evaluate the Efficacy and Tolerability of Ectoin® Containing Eye Spray (EES09) and Comparison to the Liposomal Eye Spray Tears Again® (TA) in the Treatment of Dry Eye Disease

Details for clinical trial NCT03519815

Clinical trial NCT03519815 - References