Optive Fusion/Optive Fusion UD 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.)

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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.)

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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.)

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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.)

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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.