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

Abstract

To subjectively and objectively evaluate the efficacy and tolerability of preservative-free Ectoin ® Eye Spray -Colloidal (EES09) and Tears Again ® Eye Spray (TA) in subjects with mild-moderate dry eye disease (DED), and to compare efficacy of these two eye sprays with each other. Methods: Thirty-six volunteers (average age 32.3 ± 16.1 years; 26 females) were successfully recruited for this prospective double-blind study with between-subject design and randomly divided into two groups (gender and age balanced): Group A received EES09 and Group B received TA during the treatment phase. Inclusioncriteria were a minimum age of 18 years, a score of 18.0 or higher on the OSDI questionnaire, and a non-invasive tear break up time (NIKBUT, Oculus Keratograph M5, Oculus, Germany) of no more than 10s in at least one eye. The objective variables NIKBUT, conjunctival redness, lipid layer and osmolarity (TearLab Cooperation, USA) were assessed at baseline, 10 min. after spray application and after a treatment phase of 10±3 days (3x applications daily). Symptoms, tolerance and handling were evaluated with the OSDI and VAS questionnaires. Results: A statistically significant increase in NIKBUT and improvement in DED symptoms were obtained for the overall group (mean NIKBUT 7.7 ± 1.7s vs. 11.6 ± 4.6s, p<0.001; mean OSDI score: 36.1 ± 12.7 vs. 20. 7± 12.7, p<0.001) during course of treatment. No statistically significant effect was established for the variables lipid layer (p = 0.406), conjunctival redness (p = 0.766) and osmolarity (p = 0.378). No statistically significant differences were observed between the groups, for any variable. The noninferioritycriterion for EES09 towards TA could be shown for the scores of the dry eye symptoms via VAS questionnaire and the variable NIKBUT. Conclusions: A beneficial treatment effect was confirmed for both, symptoms of DED and the objective variable NIKBUT. Both eye sprays were rated favourably in view of perceived tolerability and handling of the spray bottle.

Ectoine in the Treatment of Irritations and Inflammations of the Eye Surface

“…Interestingly, different studies were identified during this review, which reported on positive outcomes of application on ectoine-based formulations on dry eye syndrome [ 34 , 35 ]. Although these trials are not subject of this work and were excluded, it is worth to mention that additional evidence is available proving the successful treatment of the ocular surface with ectoine.…”

“…In addition, several trials showed efficacy of ectoine in various diseases with barrier dysfunctions such as rhinitis sicca [ 27 ], chemotherapy-induced mucositis [ 28 ], lung inflammation caused by environmental pollutants [ 29 ], prevention of upper respiratory infections [ 30 ], and atopic dermatitis [ 31 ]. Moreover, studies on allergic rhinoconjunctivitis [ 27 , 32 , 33 ] and dry eye syndrome [ 34 , 35 ] have been published. Among these published studies, the application of ectoine to treat ophthalmic indications prompted us to perform a detailed analysis of the use of ectoine in this field.…”

The Potential Role of SP-G as Surface Tension Regulator in Tear Film: From Molecular Simulations to Experimental Observations

“…The combination with TA enhances the effect and suggests that SP-G can only exert its full function in combination with specific lipids. TA is a phospholipid liposome spray with a high concentration of phosphatidylcholine 2-lysophosphatidylcholine, which improves the polar properties of the lipid layer (e.g., surface tension and solubility) and enhances the distribution of the lipid in the tear film [ 22 , 32 , 33 ]. First lipid simulations already pointed out the interaction with lipids [ 21 , 34 ].…”

“…Subsequently, cells were stimulated with 10 or 100 ng/mL rhuSP-G in combination with a tear replacement solution (phospholipid liposome spray—Tears Again (TA) Optima Pharmazeutische GmbH, Hallbergmoos, Germany) in sfm. TA is a phospholipid liposome spray with a high concentration of phosphatidylcholine 2-lysophosphatidylcholine, which improves the polar properties of the lipid layer (e.g., surface tension and solubility) and improves the distribution of the lipid in the tear film [ 32 , 33 , 34 ]. TA was purchased at a local pharmacy.…”

The Methods of Digging for “Gold” within the Salt: Characterization of Halophilic Prokaryotes and Identification of Their Valuable Biological Products Using Sequencing and Genome Mining Tools

“…Compatible solutes such as ectoine and hydroxyectoine are used as protective factors for cells, DNA, and proteins, which makes them highly valuable for cosmetics and medicine sectors [140,141]. Ectoine is commonly used in the cosmetics industry, but clinical trials are also conducted to indicate its importance in the treatment of eye and respiratory diseases [142][143][144][145]. In silico studies for new microorganisms producing ectoine and hydroxyectoine can be improved by using BGC identification methods like antiSMASH [146][147][148].…”