Efficacy and Safety of PRO-155 on Inflammation of the Conjunctival Surface in Subjects With Grade I-III Pterygium vs Placebo.

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-13

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Pterygium Ocular Pain Ocular Inflammation Post-surgical Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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PRO-155

Pro-155: 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac for 20 days

Group Type EXPERIMENTAL

PRO-155

Intervention Type DRUG

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

Placebo

Placebo 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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PRO-155

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

Intervention Type DRUG

Placebo

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 Type OTHER

Other Intervention Names

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zebesten bromfenac

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No