Subjective assessment of a new moisturizing mouth spray for the symptomatic relief of dry mouth.
OBJECTIVE
A randomized clinical trial (Study 1) and consumer usage test (Study 2) were conducted to evaluate the acceptability and efficacy of OASIS Mouth Moisturizing Spray in subjects experiencing dry mouth.


METHODS
Study 1: A randomized, single-blind, four-arm crossover clinical trial was conducted in 24 subjects, ranging from 50-84 years of age, to evaluate OASIS Mouth Moisturizing Spray and two experimental mouth spray formulations, and compare their performance to a reference (marketed) mouth spray, SALIVEZE. Following a three-day acclimatization phase, subjects used all four products at home for three days. Each treatment phase was separated by a three-day washout period. Study 2: One-hundred twenty subjects participated in a three-week home usage consumer test using OASIS Mouth Moisturizing Spray, after which they completed a 52-question online survey exploring sensory, efficacy, and resultant quality of life attributes of the product.


RESULTS
Study 1: On average, subjects used the four test products 2-3 times per day. OASIS Mouth Moisturizing Spray was found to be effective in relieving dry mouth in the study population, as evidenced by a statistically significant feeling of coating the mouth (p < 0.05), and statistically significantly longer dry mouth relief (p < 0.005) than the commercial control. The OASIS Mouth Moisturizing Spray was statistically significantly (p < 0.05) better and preferred over the other product tested. All the products used in the study were well-tolerated. Study 2: On a five-point scale, 73% of respondents perceived the OASIS Mouth Moisturizing Spray as "very good" or "excellent," and more than 60% gave the product an "excellent" or "very good" rating on sensory, efficacy, and quality of life attributes.


CONCLUSIONS
These studies show that OASIS Mouth Moisturizing Spray helped provide dry mouth relief and was well liked by the study population.
Shirodaria
Soha
S
GlaxoSmithKline, Weybridge, UK. Soha.C.Shirodaria@gsk.com
Kilbourn
Tony
T
Richardson
Marie
M
D000293:Adolescent; D000328:Adult; D000336:Aerosols; D000368:Aged; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011758:Pyrroles / Q000627:therapeutic use*; D012464:Saliva, Artificial / Q000627:therapeutic use*; D012472:Salivation; D013997:Time Factors; D014753:Vinyl Compounds / Q000627:therapeutic use*; D014987:Xerostomia / Q000523:psychology / Q000628:therapy*
D000336:Aerosols; D011758:Pyrroles; D012464:Saliva, Artificial; D014753:Vinyl Compounds; C118676:poly(divinyl-co-N-vinylpyrrolidinone)