Efficacy and Safety of PRO-155 on Inflammation of the Conjunctival Surface in Subjects With Grade I-III Pterygium vs Placebo.
Condition: Pterygium; Ocular Pain; Ocular Inflammation; Post-surgical Inflammation
MeSH terms: Pterygium; Inflammation
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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
    

Intervention name(s): PRO-155; Placebo
Intervention type(s): Drug; Other
Intervention description(s): PRO-155 (Zebesten ofteno®) Active agent: bromfenac 0.90 mg / mL, dropper bottle of low density polyethylene for multidose administration in the form of an ophthalmic solution of 5 mL (milliliters). Sanitary registry in Mexico: 108M2014
Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac; The placebo is constituted by agents, additives and vehicles, of the formulation PRO-155 without pharmacological activity. It is dispensed in dropper bottle of low density polyethylene for multi-dose administration in the form of ophthalmic solution of 5 mL
Sodium hyaluronate 0.4% (Lagricel ofteno®) 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac
Other intervention name(s): zebesten; bromfenac
Intervention MeSH terms: Bromfenac
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A controlled, randomized, double-blind, masked clinical trial comparing the safety and efficacy of PRO-155 in the treatment of conjunctival hyperemia in pterygium I to III compared to placebo.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: zebesten; ocular anti-inflammatory; ocular analgesic; pterygium; anti-inflammatory non-steroidal ophthalmic