Optive/Optive UD

Optive/Optive UD

Manufacturer:

Allergan

Distributor:

DKSH
Full Prescribing Info
Contents
Carboxymethylcellulose sodium, glycerin.
Description
Optive: Each mL of eye drops contains carboxymethylcellulose sodium 0.5% and glycerin 0.9%.
Optive is unique dual-action formula provides long-lasting comfort.
It lubricates the surface of the eye and moisturizes the ocular surface cells by restoring natural osmotic balance.
It contains a unique, mild, nonsensitizing preservative Purite which ultimately breaks down into natural tear components on the eye (sodium chloride and water).
Optive UD: Optive UD contains carboxymethylcellulose 0.5%; glycerin 0.9%.
It is a sterile, preservative free, unit-dose ophthalmic solution.
Excipients/Inactive Ingredients: Boric acid, calcium chloride dihydrate, erythritol, levocarnitine, magnesium chloride hexahydrate, potassium chloride, purified water, Purite (stabilized oxychloro complex) (preservative) 0.01% (Optive only), sodium borate decahydrate and sodium citrate dihydrate, L-carnitine (Optive UD only).
Action
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 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.
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 pharmacokinetic studies have been performed. Since Carboxymethylcellulose sodium is pharmacologically inert and not absorbed systemically it is not expected that safety issues 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.
Indications/Uses
Optive: For the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind or sun.
May be used as a protectant against further irritation.
Optive UD: For use as ocular lubricant in dry eye. In addition, OPTIVE UD may be used as an ocular lubricant to relieve dryness and discomfort following ocular surgery (e.g. LASIK).
Dosage/Direction for Use
Instill 1 or 2 drops in the affected eye(s) as needed.
Optive 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.
Administration: Optive: Concomitant ocular medications should be administered at least 5 minutes apart from the instillations of OPTIVE to avoid washout effects.
Optive UD:
This product is intended to be administered as ocular lubricant in dry eye.
OPTIVE UD is compatible for use with all contact lenses.
Allow 5 minutes between the administrations of ophthalmic products to avoid washout effects.
Overdosage
Since carboxymethylcellulose sodium is pharmacologically inert and not absorbed systemically, the likelihood of systemic intoxication from topical overdose is not expected from the administration of OPTIVE/OPTIVE UD. Additionally, no toxic side effects are expected should accidental systemic overdose occur.
Contraindications
OPTIVE/OPTIVE UD is contraindicated in patients with hypersensitivity to any ingredients in this product.
Special Precautions
Do not use if allergic to any of the ingredients. Do not swallow solution.
To avoid contamination or possible eye injury, do not touch bottle tip on any surface, and avoid contact with the eye and replace the cap after using.
Do not use if OPTIVE/OPTIVE UD packaging shows evidence of tampering.
Do not use if solution changes color or becomes cloudy. Use before the expiration date marked on the container.
Discontinue to use Optive/Optive UD and consult a doctor if patient experiences eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.
Effects on the Ability to Drive or Operate Machinery: Optive/Optive UD may cause transient blurring of vision which may impair the ability to drive or operate machines. The patients should wait until their vision has cleared before driving or using machinery.
Use in Children: Safety and effectiveness have not been demonstrated with OPTIVE/OPTIVE UD in pediatric patients.
Use in Elderly: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
Use In Pregnancy & Lactation
Use in Pregnancy: There are no specific study on the use of OPTIVE/OPTIVE 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.
Use in Lactation: OPTIVE/OPTIVE UD has also not been studied in breast feeding women, however, OPTIVE/OPTIVE UD is not expected to have significant systemic absorption; therefore, it would not be excreted in human breast milk.
Adverse Reactions
Optive: Treatment of Dry Eye: A study was conducted to evaluate OPTIVE in comparison with established therapies, Systane and Cellufresh MD for dry eye. A total of 97 patients received OPTIVE, 95 patients received Systane, and 94 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. (See Table 1.)

Click on icon to see table/diagram/image

Contact Lens Lubricant and Rewetter: Another study was conducted to provide evidence supporting the claim that OPTIVE 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 166 patients were randomized into the OPTIVE cohort and dispensed lenses; 79 were randomized into the Cellufresh MD cohort (control) and dispensed lenses. All of the adverse reactions reported that were associated with OPTIVE were considered mild and none exceeded 2% of the OPTIVE patients treated.
Postmarketing Experience: The following additional adverse reactions have been identified during postmarketing use of OPTIVE 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.
Optive UD: Treatment of Dry Eye: A study was conducted to evaluate OPTIVE UD in comparison with an established therapy, Cellufresh in dry eye. In this study, 157 patients received OPTIVE UD, and 159 patients received Cellufresh. In this study, most adverse reactions were ocular and mild and none were serious.
Table 2 presents the most frequent adverse reactions reported for at least 2% of subjects receiving OPTIVE UD. (See Table 2.)

Click on icon to see table/diagram/image

Treatment of Dry Eye Symptoms Following LASIK Surgery: A study was conducted to evaluate OPTIVE UD in comparison with an established therapy, Cellufresh in post-LASIK patients. A total of 114 patients received either OPTIVE UD or Cellufresh. The most frequent adverse reactions reported by at least 2% of patients receiving OPTIVE UD are presented in Table 3. The most frequent reactions reported by at least 2% of patients and determined to be related to the LASIK surgical procedure are presented in Table 4. (See Tables 3 and 4.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Postmarketing Experience: The following additional adverse reactions have been identified during postmarketing use of OPTIVE 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.
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 below 25°C.
Optive: Discard 6 months after opening.
Shelf-Life: 18 months.
ATC Classification
S01XA20 - artificial tears and other indifferent preparations ; Belongs to the class of other ophthalmologicals.
Optive: E; Optive UD: S
Presentation/Packing
Optive eye drops 15 mL. Optive UD ophth soln 0.4 mL x 30's.
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