efficacy and safety of pro-155 on inflammation of the conjunctival surface in subjects with grade i-iii pterygium vs placebo.

Conditions: Pterygium; Ocular Pain; Ocular Inflammation; Post-surgical Inflammation

Summary: title of the study efficacy and safety of pro-155 (zebesten ofteno®) on inflammation of the conjunctival surface in subjects with grade i-iii pterygium vs placebo. hypothesis h0. the zebesten® ophthalmic solution (bromfenac 0.09%) is less effective and safe than placebo in reducing conjunctival hyperemia in subjects with grade i-iii pterygium. h1 the zebesten® ophthalmic solution (bromfenac 0.09%) is more effective and safe than placebo in reducing conjunctival hyperemia in subjects with grade i-iii pterygium. objective to evaluate the efficacy and safety of pro-155 (bromfenac 009%) ophthalmic solution in the treatment of conjunctival hyperemia and ocular surface inflammation in a clinical model of pterygium grade i to iii.

variables to be evaluated visual ability intraocular pressure. ocular surface exploration of the previous segment. exploration of the posterior segment. lacrimal rupture time. corneal de-epithelialization conjunctival de-epithelialization adverse events. pharmacological intervention the pharmacological intervention will consist of the instillation of the ophthalmological solution in the conjunctival cul-de-sac, during the waking period, to any of the following study groups: * group 1: * sodium hyaluronate 0.4% \[lagricel ofteno®\] 1 drop 3 times a day in the period of vigil in the conjunctival sac fund (the following application scheme is suggested: start: 7:00 ± 1 hours, continuation: 15:00 ± 1 hour and term: at 19:00 ± 1 hours) for 20 days * pro-155 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac (the following application scheme is recommended: start: 7:15 ± 1 hours and term: at 19:15 ± 1 hours) during 20 days * group 2: * sodium hyaluronate 0.4% \[lagricel ofteno®\] 1 drop 3 times a day in the period of vigil in the conjunctival sac fund (the following application scheme is suggested: start: 7:00 ± 1 hours, continuation: 15:00 ± 1 hour and term: at 19:00 ± 1 hours) for 20 days * placebo 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac (the following application scheme is recommended: start: 7:15 ± 1 hours and term: at 19:15 ± 1 hours) for 20 days

Eligibility criteria:
inclusion criteria: * age of 18 to 90 years. * both genders. * clinical diagnosis of grade i to iii pterygium (temporal, nasal, or bitemporal). * possibility of going to the revisions when indicated. exclusion criteria: * subjects with topical or systemic medication that interfere decisively in the results of the study; such as topical immunomodulators, nsaids, antihistamines, corticosteroids, artificial tears with conservative, vasoconstrictors etc. * subjects (female) with active sexual life who do not use a contraceptive method. * subjects of the female sex in a pregnant state or who are breastfeeding. * subjects of the female sex with pregnancy test in positive urine. * positive substance abuse * subjects who have participated in any clinical research study in the last 40 days. * subjects legally or mentally incapacitated to give their informed consent for their participation in this study. * subjects that can not comply with the appointments or with all the requirements of the protocol.

Keywords: zebesten ocular anti-inflammatory ocular analgesic pterygium anti-inflammatory non-steroidal ophthalmic