Optive Fusion/Optive Fusion UD

Optive Fusion/Optive Fusion UD

Manufacturer:

Allergan

Distributor:

DKSH
Full Prescribing Info
Contents
Optive Fusion: Carboxymethylcellulose sodium, glycerin, sodium hyaluronate (biological excipient).
Optive Fusion UD: Carboxymethylcellulose sodium, glycerin, sodium hyaluronate (biological excipient).
Description
Optive Fusion/Optive Fusion UD is compatible for use with contact lenses.
Optive Fusion: Active ingredients: Carboxymethylcellulose (INN: Carmellose) sodium 0.5%, Glycerin (INN: Glycerol) 0.9%.
Biological excipients: Sodium hyaluronate 0.1%.
Optive Fusion UD: Active ingredients: Carboxymethylcellulose (INN: Carmellose) sodium 0.5%, Glycerin (INN: Glycerol) 1.0%.
Biological excipient: Sodium hyaluronate 0.1%.
Excipients/Inactive Ingredients: Optive Fusion: Erythritol, Boric acid, Sodium borate decahydrate, Sodium citrate dihydrate, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate and Purified water.
Preservative: Stabilized oxychloro complex (PURITE).
Optive Fusion UD: Erythritol, Levocarnitine, Sodium lactate, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate and Purified water.
Action
Pharmacology: Pharmacodynamics: No clinical pharmacology studies were performed with Optive Fusion/Optive Fusion 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. 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 Fusion/Optive Fusion 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 Fusion/Optive Fusion UD.
Indications/Uses
Optive Fusion/Optive Fusion UD 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 Fusion/Optive Fusion UD hydrates the surface of the eyes for relief of the symptoms of dryness, stinging, grittiness, or foreign body sensation caused by environmental factors. Optive Fusion/Optive Fusion UD 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 Fusion/Optive Fusion UD is compatible with contact lenses.
Optive Fusion: Optive Fusion are indicated to lubricate and rewet soft and rigid gas permeable contact lenses, to help relieve dryness, discomfort, and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens before insertion on the eye.
Optive Fusion UD: Optive Fusion UD may also be used as an ocular lubricant to relieve dryness and discomfort following ocular surgery (e.g. LASIK).
Dosage/Direction for Use
Recommended Dose: Instill 1 or 2 drops in the affected eye(s) as needed.
Optive Fusion: If Optive Fusion is used to lubricate and rewet contact lenses, apply 1 to 2 drops to each eye as needed with the contact lens on the eye. If desired, 1 or 2 drops may be placed on the contact lens before insertion.
Optive Fusion UD: If used for post-operative care (e.g. following LASIK surgery), it is recommended for the patient to follow their eye doctor's instructions.
Mode of Administration: Concomitant ocular medications should be administered at least 5 minutes apart from the instillation of Optive Fusion/Optive Fusion UD to avoid washout effects.
Overdosage
Since carboxymethylcellulose sodium is pharmacologically inert and not absorbed systemically, systemic intoxication from topical overdose is not expected from ocular administration of Optive Fusion/Optive Fusion UD. 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 Fusion/Optive Fusion UD, 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 Fusion/Optive Fusion UD.
Contraindications
Optive Fusion/Optive Fusion UD is contraindicated in patients with hypersensitivity to any ingredients in this product.
Special Precautions
To avoid contamination or possible eye injury, do not touch tip of the vial to any surface and avoid contact with the eye.
Discard the vial immediately after use.
Do not use if Optive Fusion/Optive Fusion UD packaging shows evidence of tampering. Do not use if solution changes color or becomes cloudy.
Discontinue use of Optive Fusion/Optive Fusion UD and consult a doctor if the patient experiences eye pain, changes in vision, continued redness or irritation of the eye, or if the conditions worsen.
Effects on ability to drive and use machines: Optive Fusion/Optive Fusion UD 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 Fusion/Optive Fusion UD in pediatric patients.
Use in the Elderly: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
Use In Pregnancy & Lactation
Pregnancy: There are no specific study data on the use of Optive Fusion/Optive Fusion UD 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 Fusion/Optive Fusion UD has also not been studied in breast-feeding women; however, Optive Fusion/Optive Fusion UD is not expected to have significant systemic absorption; therefore, it would not be excreted in human breast milk.
Adverse Reactions
Optive Fusion: Treatment of Dry Eye - Clinical Study 10078X-001: Study 10078X-001 was conducted to evaluate Optive Fusion (10077X) and formulation 10078X in comparison with Cellufresh MD for dry eye. A total of 102 patients received Optive Fusion, 101 patients received 10078X, and 103 patients received Cellufresh MD. In this study, most adverse reactions were ocular and mild and none were serious. Table 1 presents the most frequent adverse reactions reported for at least 2% of subjects receiving Optive Fusion. (See Table 1.)

Click on icon to see table/diagram/image

Contact Lens Lubricant and Rewetter - Clinical Study 10077X-001: Study 10077X-001 was conducted to provide evidence supporting the claim that Optive Fusion is substantially equivalent to Cellufresh MD for lubricating and rewetting lenses; relieving dryness, discomfort and irritation associated with lens wear; and cushioning lenses upon insertion. A total of 244 patients received the Optive Fusion and dispensed lenses; 121 patients received the Cellufresh MD and dispensed lenses. The most frequent adverse reaction reported by at least 2% of patients receiving Optive Fusion is presented in Table 2. (See Table 2.)

Click on icon to see table/diagram/image

Optive Fusion UD: Treatment of Dry Eye - Clinical Study 11002X-001: Study 11002X-001 was conducted to evaluate Optive Fusion UD in comparison with OPTIVE UD for dry eye. A total of 224 patients received Optive Fusion UD and 236 patients received OPTIVE UD. In this study, most adverse reactions were ocular and mild and none were serious. Table 3 presents the most frequent adverse reactions reported for at least 2% of subjects receiving Optive Fusion UD. (See Table 3.)

Click on icon to see table/diagram/image

Treatment of Dry Eye Symptoms Following LASIK Surgery - Clinical Study 11002X-002: Study 11002X-002 was conducted to evaluate Optive Fusion UD in comparison with an established therapy, Cellufresh UD in post-LASIK patients. A total of 75 patients received Optive Fusion UD and 73 patients received Cellufresh UD. The most frequent adverse reactions reports by at least 2% of patients receiving Optive Fusion UD are presented in Table 4. These reactions could also be related to the LASIK surgical procedure. (See Table 4.)

Click on icon to see table/diagram/image

Postmarketing Experience: The following additional adverse reactions have been identified during postmarketing use of Optive Fusion/Optive Fusion UD 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.
Optive Fusion: Eye disorders: Eye discharge, Eye irritation, Eyelid edema, Foreign body sensation in eyes, Lacrimation increased, Eye swelling.
Immune System Disorders: Hypersensitivity.
Optive Fusion UD: Eye disorders: Eye irritation, Ocular hyperemia, Eye pain, Eye pruritus.
Poisons and Procedural Complications: Superficial injury of the eye.
Drug Interactions
No known drug interactions.
Storage
Store at or below 30°C.
Store unused vials in the original carton.
Shelf-life: 24 months.
Optive Fusion: Optive Fusion bottle should be kept tightly closed when not in use.
Optive Fusion UD: Keep vials away from sunlight.
ATC Classification
S01XA20 - artificial tears and other indifferent preparations ; Belongs to the class of other ophthalmologicals.
Optive Fusion: S; Optive Fusion UD: NDD
Presentation/Packing
Optive Fusion: Ophth soln 10 mL (sterile, preservative-free unit dose) x 1's. Optive Fusion UD: Ophth soln (vial) 0.4 mL (sterile, preservative-free unit dose) x 3 x 10's.
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