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

Pterygium Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03521791
• Other study ID #: SOPH155-0415/IV
• Status: Completed
• Phase: Phase 4
• Start date: December 13, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: October 2019
• Source: Laboratorios Sophia S.A de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: October 31, 2018
• Est. primary completion date: September 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Ocular Inflammation
• Ocular Pain
• Post-surgical Inflammation
• Pterygium

Intervention

Drug:
• 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

Other:
• 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

Locations

Country	Name	City	State
Mexico	Consultorio PRivado Miguel Angel Villanueva	Ciudad de México
Mexico	catarata y glaucoma de occidente S.A de C.V.	Guadalajara	Jalisco
Mexico	Novam y Vita	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Sophia S.A de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Eyes With Ocular Burning (OB)	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.	will be evaluated at the end of the treatment at the final visit (day 21)
Primary	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.	will be evaluated at the end of the treatment at the final visit (day 21)
Primary	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.	will be evaluated at the end of the treatment at the final visit (day 21)
Secondary	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.	will be evaluated at the end of the treatment at the final visit (day 21)
Secondary	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	will be evaluated at the end of the treatment at the final visit (day 21)
Secondary	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	will be evaluated at the end of the treatment at the final visit (day 36)
Secondary	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.	will be evaluated at the end of the treatment at the final visit (day 21)
Secondary	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.	will be evaluated at the end of the treatment at the final visit (day 21)
Secondary	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.	will be evaluated at the end of the treatment at the final visit (day 21)
Secondary	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.	will be evaluated at the end of the treatment at the final visit (day 21)