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

Primary Purpose

Pterygium, Ocular Pain, Ocular Inflammation

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
PRO-155
Placebo
Sponsored by
Laboratorios Sophia S.A de C.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium focused on measuring zebesten, ocular anti-inflammatory, ocular analgesic, pterygium, anti-inflammatory non-steroidal ophthalmic

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • catarata y glaucoma de occidente S.A de C.V.
  • Novam y Vita
  • Consultorio PRivado Miguel Angel Villanueva

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PRO-155

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Conjunctival Hyperemia (CH)
Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.
Breakup Time (BUT)
breakup time lacrimal film is a continuous variable that will be measured in seconds, evaluating the time it takes to break it, is done by direct counting and the normality range and mayor to 10 seconds.

Secondary Outcome Measures

Epithelial Defects (ED) Green Lissamine
The epithelial defects will be evaluated by means of two stains, green lysine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.
Intraocular Pressure (IOP)
the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg
Presence of Adverse Events (EAS)
primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent. Adverse events that are reported until the safety call to the 36th day of the study will be considered for this variable
Visual Capacity
The visual capacity variable will be reported using as a unit of measure a fraction, this is taken from a visual test with the Snellen primer, it is a Nominal type variable. where the optimal vision is 20/20.
Number of Eyes With Chemosis
In a normal eye there is no presence of chemosis (it is a sign of irritation of the eye, in which the outer covering of the eye can look like a large blister) its presence indicates a pathological state and it will be evaluated if the subjects present it. The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.
Number of Eyes With Foreign Body Sensation (FBS)
Foreign body sensation will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.
Epithelial Defects (ED) Fluorescein Stain
The epithelial defects will be evaluated by means of two stains, green lysine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.

Full Information

First Posted
April 30, 2018
Last Updated
October 30, 2019
Sponsor
Laboratorios Sophia S.A de C.V.
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1. Study Identification

Unique Protocol Identification Number
NCT03521791
Brief Title
Efficacy and Safety of PRO-155 on Inflammation of the Conjunctival Surface in Subjects With Grade I-III Pterygium vs Placebo.
Acronym
PRO-155/IV
Official Title
Efficacy and Safety of PRO-155 (Zebesten Ofteno®) on Inflammation of the Conjunctival Surface in Subjects With Grade I-III Pterygium vs Placebo.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 13, 2017 (Actual)
Primary Completion Date
September 14, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Sophia S.A de C.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium, Ocular Pain, Ocular Inflammation, Post-surgical Inflammation
Keywords
zebesten, ocular anti-inflammatory, ocular analgesic, pterygium, anti-inflammatory non-steroidal ophthalmic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRO-155
Arm Type
Experimental
Arm Description
Pro-155: 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac for 20 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac
Intervention Type
Drug
Intervention Name(s)
PRO-155
Other Intervention Name(s)
zebesten, bromfenac
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Conjunctival Hyperemia (CH)
Description
Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.
Time Frame
will be evaluated at the end of the treatment at the final visit (day 21)
Title
Breakup Time (BUT)
Description
breakup time lacrimal film is a continuous variable that will be measured in seconds, evaluating the time it takes to break it, is done by direct counting and the normality range and mayor to 10 seconds.
Time Frame
will be evaluated at the end of the treatment at the final visit (day 21)
Secondary Outcome Measure Information:
Title
Epithelial Defects (ED) Green Lissamine
Description
The epithelial defects will be evaluated by means of two stains, green lysine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.
Time Frame
will be evaluated at the end of the treatment at the final visit (day 21)
Title
Intraocular Pressure (IOP)
Description
the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg
Time Frame
will be evaluated at the end of the treatment at the final visit (day 21)
Title
Presence of Adverse Events (EAS)
Description
primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent. Adverse events that are reported until the safety call to the 36th day of the study will be considered for this variable
Time Frame
will be evaluated at the end of the treatment at the final visit (day 36)
Title
Visual Capacity
Description
The visual capacity variable will be reported using as a unit of measure a fraction, this is taken from a visual test with the Snellen primer, it is a Nominal type variable. where the optimal vision is 20/20.
Time Frame
will be evaluated at the end of the treatment at the final visit (day 21)
Title
Number of Eyes With Chemosis
Description
In a normal eye there is no presence of chemosis (it is a sign of irritation of the eye, in which the outer covering of the eye can look like a large blister) its presence indicates a pathological state and it will be evaluated if the subjects present it. The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.
Time Frame
will be evaluated at the end of the treatment at the final visit (day 21)
Title
Number of Eyes With Foreign Body Sensation (FBS)
Description
Foreign body sensation will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.
Time Frame
will be evaluated at the end of the treatment at the final visit (day 21)
Title
Epithelial Defects (ED) Fluorescein Stain
Description
The epithelial defects will be evaluated by means of two stains, green lysine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.
Time Frame
will be evaluated at the end of the treatment at the final visit (day 21)
Other Pre-specified Outcome Measures:
Title
Number of Eyes With Ocular Burning (OB)
Description
primary tolerability variable Ocular burning is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time.
Time Frame
will be evaluated at the end of the treatment at the final visit (day 21)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leopoldo Baiza Durán, MD
Organizational Affiliation
Laboratorios Sophia S.A de C.V.
Official's Role
Study Director
Facility Information:
Facility Name
catarata y glaucoma de occidente S.A de C.V.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Novam y Vita
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44620
Country
Mexico
Facility Name
Consultorio PRivado Miguel Angel Villanueva
City
Ciudad de México
ZIP/Postal Code
06700
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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