Abstract

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.

METHODOLOGY:

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.

CONCLUSION:

These studies show that OASIS Mouth Moisturizing Spray helped provide dry mouth relief and was well liked by the study population.