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Pharmacology: Pharmacodynamics: No clinical pharmacology studies were performed with OPTIVE/OPTIVE UD.
Carboxymethylcellulose sodium has no pharmacological receptor-mediated properties. The mode of action of carboxymethylcellulose sodium is based on its physical properties which provide a lubricant effect and prolonged residence time in the eye. Carboxymethylcellulose sodium increases tear viscosity and has pseudo-elastic (i.e. shear thinning) properties. Since carboxymethylcellulose sodium is an ionic polymer containing carboxyl and hydroxyl groups, its chemical structure is similar to mucin in the tear film, and thus it has mucoadhesive properties. These properties promote prolonged residence times in the eye which alleviate the symptoms of tear deficiency.
The mode of action of glycerin in eye drops is based on its physical properties. It has no pharmacological receptor-mediated properties. In the U.S., glycerin is described as an ophthalmic demulcent – an agent which is applied topically to the eye to protect and lubricate mucous membrane surfaces and relieve dryness and irritation.
OPTIVE UD: A multicenter, double-masked, three-month parallel-group study was conducted in which 228 subjects were randomized following LASIK refractive surgery to use OPTIVE UD or Refresh Plus (Cellufresh) unit dose lubricant eye drops. For the primary analysis of this study, the mean Ocular Surface Disease Index (OSDI) score of the two treatment groups was compared at Day 90. Based on the 95% confidence intervals, OPTIVE UD was demonstrated to be non-inferior to Refresh Plus (Cellufresh). Comparison between treatment groups for other study variables supported this finding. There was a statistically-significant difference (p = 0.039) in corneal staining between the two groups at Day 14 in favor of OPTIVE UD. Subject questionnaires demonstrated that OPTIVE UD was acceptable to the majority of post-LASIK patients, and similar to Refresh Plus (Cellufresh). Adverse event rates were similar between groups and typical of post-LASIK patients. The high completion rate and low adverse event rate are supportive of the safety of OPTIVE UD in post-LASIK clinical use.
An additional multicenter, double-masked, randomized, two-arm, parallel-group study to compare the efficacy, safety and acceptability of OPTIVE UD eye drops with Refresh Plus (Cellufresh) Unit-Dose Lubricant eye drops for one month was conducted in subjects (N = 316) with mild, moderate or severe symptoms of dry eye. The study results showed that OPTIVE UD improved signs and symptoms of dry eye over the thirty day treatment period in the subjects with mild to severe symptoms of dry eye. OPTIVE UD produced generally similar clinical results as the comparator product Refresh Plus (Cellufresh), and was found safe and acceptable for use in the majority of study subjects.
Pharmacokinetics: No ocular pharmacokinetic studies have been performed. Since carboxymethylcellulose sodium is pharmacologically inert and not absorbed systemically, it is not expected that safety concerns will arise from the topical administration of OPTIVE/OPTIVE UD.
Glycerin is a small molecule that is found throughout the body as a natural metabolic compound. In the low concentrations present in OPTIVE/OPTIVE UD, it will mix with the natural pool of glycerin in the body tissues without significant effect.
Optive UD: Glycerin is a 3 - carbon alcohol that is naturally occurring in the human body. Glycerin is rapidly absorbed in the intestine and the stomach, distributed over the extracellular space and excreted. It is metabolized to glucose and glycogen and may also combine with free fatty acids to form triglycerides which are distributed to adipose tissue where cell turnover occurs. Systemic intoxication from topical overdose is not expected given the low systemic exposure of glycerin via topical administration of OPTIVE UD.
