Naproxen ophthalmic solution to manage inflammation after phacoemulsification

Papa, V; Milazzo, Giovanni; Santocono, Marcello; Servolle, Valerie; Sourdille, P; Santiago, P. Y.; Darondeau, J.; Cassoux, Nathalie; LeHoang, Phuc

doi:10.1016/s0886-3350(01)01077-x

Cited by 19 publications

(18 citation statements)

References 15 publications

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“…In a comparative study, naproxen sodium (0.2%, wt/vol) drops were found to be as effective as diclofenac sodium (0.1%, wt/vol) drops in controlling post operative inflammation after uncomplicated cataract surgery (82). Naproxen (0.1%, wt/vol and 0.2%, wt/vol) eye drops were explored for controlling ocular inflammation in patients having phacoemulsification and intra ocular lens implantation (83). Naproxen eye drops were found to be safer and tolerable.…”

Section: Naproxenmentioning

confidence: 99%

Topical Ocular Delivery of NSAIDs

Ahuja

Dhake²,

Sharma

et al. 2008

AAPS J

189

148

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Abstract. In ocular tissue, arachidonic acid is metabolized by cyclooxygenase to prostaglandins which are the most important lipid derived mediators of inflammation. Presently nonsteroidal anti-inflammatory drugs (NSAIDs) which are cyclooxygenase (COX) inhibitors are being used for the treatment of inflammatory disorders. NSAIDs used in ophthalmology, topically, are salicylic-, indole acetic-, aryl acetic-, aryl propionicand enolic acid derivatives. NSAIDs are weak acids with pKa mostly between 3.5 and 4.5, and are poorly soluble in water. Aqueous ophthalmic solutions of NSAIDs have been made using sodium, potassium, tromethamine and lysine salts or complexing with cyclodextrins/solubilizer. Ocular penetration of NSAID demands an acidic ophthalmic solution where cyclodextrin could prevent precipitation of drug and minimize its ocular irritation potential. The incompatibility of NSAID with benzalkonium chloride is avoided by using polysorbate 80, cyclodextrins or tromethamine. Lysine salts and α-tocopheryl polyethylene glycol succinate disrupt corneal integrity, and their use requires caution. Thus a nonirritating ophthalmic solution of NSAID could be formulated by dissolving an appropriate water-soluble salt, in the presence of cyclodextrin or tromethamine (if needed) in mildly acidified purified water (if stability permits) with or without benzalkonium chloride and polyvinyl alcohol. Amide prodrugs met with mixed success due to incomplete intraocular hydrolysis. Suspension and ocular inserts appear irritating to the inflamed eye. Oil drop may be a suitable option for insoluble drugs and ointment may be used for sustained effect. Recent studies showed that the use of colloidal nanoparticle formulations and the potent COX 2 inhibitor bromfenac may enhance NSAID efficacy in eye preparations.

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Section: Naproxenmentioning

confidence: 99%

Topical Ocular Delivery of NSAIDs

Ahuja

Dhake²,

Sharma

et al. 2008

AAPS J

189

148

View full text Add to dashboard Cite

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“…AC inflammation was evaluated by slit-lamp examination and scored from none to severe using a 0-3 point scale as already described. 21 Other criteria of efficacy included conjunctival hyperaemia, corneal and lid oedema, ocular infection, and ocular discomfort. The tolerance variables assessed were the degree of burning, stinging, and blurred vision.…”

Section: Discussionmentioning

confidence: 99%

“…All these clinical variables were also graded from none to severe using a 0-3 point scale. 21 Safety variables that were monitored during the trial were visual acuity, IOP, and funduscopy. Only two physicians have been involved in all clinical evaluation.…”

Section: Discussionmentioning

confidence: 99%

Dexamethasone–netilmicin: a new ophthalmic steroid–antibiotic combination. Efficacy and safety after cataract surgery

Russo¹,

Papa²,

Bella³

et al. 2005

Eye

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Purpose The purpose of this study was to evaluate both efficacy and safety of a new ophthalmic steroid-antibiotic fixed combination containing dexamethasone and netilmicin in the postsurgical management of cataract surgery. Methods In total, 223 patients were randomly treated with dexamethasone 1 mg/ml plus netilmicin 3 mg/ml (n ¼ 148), or dexamethasone 1 mg/ml plus tobramycin 3 mg/ ml (n ¼ 75, TOBRADEX s ) four times in a day for 771 days starting immediately after surgery. Efficacy (anterior chamber (AC) inflammation, conjunctival hyperaemia, corneal and lid oedema, ocular infection, pain, photophobia and tearing) and safety (burning, stinging, blurred vision, intraocular pressure, and visual acuity) were analysed in the operated eye after 1 and 771 days. A followup visit was performed at day 1472. The extent of AC inflammation, measured by slitlamp according to a standard scoring system, was used as primary efficacy parameter. Results At the primary end point (day 7) both fixed combinations were equally effective in reducing postoperative inflammation. The safety profile of the dexamethasone/netilmicin combination was excellent with no evidence of poor local tolerance or adverse reaction. Conclusions A new fixed combination of dexamethasone and netilmicin was effective and safe in controlling ocular inflammation after cataract surgery.

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“…8 A recent study has also shown that this new ophthalmic solution is as effective as diclofenac sodium in controlling postsurgical inflammation in patients who undergo cataract extraction. 9 Cataract extraction is associated with increased PG levels in the aqueous. 2 These PGs are released as part of the inflammatory response and may enhance the action of the iris sphincter causing pupil constriction before and during surgery.…”

Section: Discussionmentioning

confidence: 99%

“…8 This ophthalmic solution is also effective in preventing and controlling ocular inflammation after cataract surgery. 9 In the present study we assessed the ability of naproxen eye drops to penetrate the cornea and to maintain mydriasis during the two most common cataract operation procedures, ie extracapsular cataract surgery and phacoemulsification.…”

Section: Introductionmentioning

confidence: 99%

Topical naproxen sodium for inhibition of miosis during cataract surgery. Prospective, randomized clinical trials

Papa

Russo

et al. 2002

Eye

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Results In both studies the pupillary diameter decreased during surgery within each treatment group in a statistically significant manner (P Ͻ 0.001). Naproxen was more effective than placebo (P Ͻ 0.01) and as effective as diclofenac in controlling pupil diameter regression during cataract. Mean concentration level of naproxen in the aqueous humor was 372.3 ng/ml. Conclusions Naproxen sodium ophthalmic solution penetrates the cornea and it is effective in maintaining intraoperative mydriasis.

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Naproxen ophthalmic solution to manage inflammation after phacoemulsification

Abstract: These preliminary results suggest that naproxen ophthalmic solution may be effectively and safely used to control inflammation after uneventful phacoemulsification. Because of the limited number of patients, larger studies are needed to confirm these results.

Cited by 19 publications

References 15 publications

Topical Ocular Delivery of NSAIDs

Topical Ocular Delivery of NSAIDs

Dexamethasone–netilmicin: a new ophthalmic steroid–antibiotic combination. Efficacy and safety after cataract surgery

Topical naproxen sodium for inhibition of miosis during cataract surgery. Prospective, randomized clinical trials

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