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.
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/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.
Optive: Eye Disorders: Eye discharge, Eye irritation, Eyelid edema, Foreign body sensation in eyes, Lacrimation increased, Eye swelling.
Immune System Disorders: Hypersensitivity.
Optive UD: Eye disorders: Eye irritation, Ocular hyperemia, Eye pain, Eye pruritus.
Poisons and Procedural Complications: Superficial injury of the eye.