Optive Gel Drops

A clear, colorless, viscous and sterile solution, preserved multidose ophthalmic solution.
Optive Gel Drops is compatible for use with contact lenses.
Active ingredients: Carboxymethylcellulose (INN: Carmellose) sodium 1.0%, Glycerin (INN: Glycerol) 0.9%.
Excipients/Inactive Ingredients: Erythritol, Levocarnitine, Boric acid, Sodium borate decahydrate, Sodium citrate dihydrate, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate and Purified water.
Preservative: Stabilized oxychloro complex (PURITE).

Pharmacology: Pharmacodynamics: No clinical pharmacology studies were performed with Optive Gel Drops.
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. In the US, carboxymethylcellulose 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.
The mode of action of glycerin in eye drops is based on its physical properties. It has no pharmacological receptor-mediated properties. In the US, 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.
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 Gel Drops.
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 Gel Drops.

Optive Gel Drops is used for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun, and may be used as a protectant against further irritation.
Optive Gel Drops hydrates the surface of the eyes for relief of the symptoms of dryness, stinging, grittiness, or foreign body sensation caused by environmental factors. Optive Gel Drops also provides relief of eye discomfort and visual symptoms caused by reduced blink frequency due to prolonged television watching or concentrated computer screen work.
Optive Gel Drops is compatible with contact lenses.

Recommended Dose: Instill 1 or 2 drops of Optive Gel Drops in the affected eye(s) as needed.
Mode of Administration: Concomitant ocular medications should be administered at least 15 minutes apart from the instillation of Optive Gel Drops to avoid washout effects.

Since carboxymethylcellulose sodium is pharmacologically inert and not absorbed systemically, systemic intoxication from topical overdose is not expected from ocular administration of Optive Gel Drops. Additionally, no adverse effects are expected should accidental systemic overdose occur.
Glycerin is a small molecule that is found throughout the body as a natural metabolic compound. In the low concentrations present in Optive Gel Drops, it will combine with endogenous glycerin in the body tissue without significant effect. Systemic intoxication from topical overdose is not expected given the low systemic exposure of glycerin via topical administration of Optive Gel Drops.

Optive Gel Drops is contraindicated in patients with hypersensitivity to any ingredients in this product.

To avoid contamination or possible eye injury, do not touch tip of the bottle to any surface and avoid contact with the eye.
Re-cap after use.
Do not use if Optive Gel Drops packaging shows evidence of tampering. Do not use if solution changes color or becomes cloudy.
Discontinue use of Optive Gel Drops and consult a doctor if the patient experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens.
Use before the expiration date marked on the container.
Effects on ability to drive and use machines: Optive Gel Drops may cause transient blurring of vision which may impair the ability to drive or operate machines. The patient should wait until their vision has cleared before driving or using machinery.
Use in Children: Safety and effectiveness have not been demonstrated with Optive Gel Drops in pediatric patients.
Use in the Elderly: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Pregnancy: There are no specific study data on the use of Optive Gel Drops during pregnancy and lactation in humans; however, animal studies with CMC have not demonstrated any harmful effects in pregnancy. Animal studies using glycerin have shown no evidence of teratogenicity.
Lactation: Optive Gel Drops has also not been studied in breast-feeding women; however, Optive Gel Drops is not expected to have significant systemic absorption; therefore, it would not be excreted in human breast milk.

Treatment of Dry Eye-Clinical Study 11193X-001: Study 11193X-001 was conducted to evaluate Optive Gel Drops (11193X) in comparison with Celluvisc MD for dry eye. A total of 94 patients received Optive Gel Drops and 94 patients received Celluvisc MD. In this study, most adverse reactions were ocular and mild in severity. The following table presents the most frequent adverse reactions reported for at least 2% of subjects receiving Optive Gel Drops. (See table.)

Click on icon to see table/diagram/image

Postmarketing Experience: The following additional adverse reactions have been identified during postmarketing use of Optive Gel Drops in clinical practice. Because postmarketing reporting of these reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions.
Eye disorders: Eye discharge, eye irritation, eyelid edema, foreign body sensation in eyes, lacrimation increased, eye swelling.
Immune System Disorders: Hypersensitivity.

No known drug interactions.

Stored at or below 30°C.
30 day discard after use.
Optive Gel Drops bottle should be kept tightly closed when not in use.
Shelf-life: 24 months.

Ophthalmic Lubricants

S01XA20 - artificial tears and other indifferent preparations ; Belongs to the class of other ophthalmologicals.

S