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
Intervention: PRO-155; Placebo
Intervention description: 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
Intervention MeSH terms: Bromfenac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
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)
Masking description: The double-blind study is a procedure in which the subject and the principal investigator do not know which of the intervention groups was assigned to the subject of the study. To achieve the blinding of the drug, both the investigational drug and the placebo, will be packed in the same bottle, containing the same legends on the label. The blinding codes are protected by a person outside the study designated by the sponsor. The codes are also available in the research center (fully sealed), so that they can be consulted by the Investigator in the event that the subject presents a serious adverse event, prior authorization of the study sponsor, as well as strict continuous blindness during the analysis of data.
Enrollment: 166.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: zebesten; ocular anti-inflammatory; ocular analgesic; pterygium; anti-inflammatory non-steroidal ophthalmic

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.
    

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.