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

NCT03521791 | Completed Phase 4 Results DMC

• 1 other identifier: SOPH155-0415/IV
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 3

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.

Conditions

Pterygium; Ocular Pain; Ocular Inflammation; Post-surgical Inflammation

Keywords

zebesten; ocular anti-inflammatory; ocular analgesic; pterygium; anti-inflammatory non-steroidal ophthalmic

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (7)

• Epithelial Defects (ED) Green Lissamine

  will be evaluated at the end of the treatment at the final visit (day 21)

• Intraocular Pressure (IOP)

  will be evaluated at the end of the treatment at the final visit (day 21)

• Presence of Adverse Events (EAS)

  will be evaluated at the end of the treatment at the final visit (day 36)

• Visual Capacity

  will be evaluated at the end of the treatment at the final visit (day 21)

• Number of Eyes With Chemosis

  will be evaluated at the end of the treatment at the final visit (day 21)

Other Outcomes (1)

• Number of Eyes With Ocular Burning (OB)

  will be evaluated at the end of the treatment at the final visit (day 21)

Study Arms (2)

PRO-155

EXPERIMENTAL

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

Drug: PRO-155

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

PRO-155 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

Also known as: zebesten, bromfenac

PRO-155

Placebo 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

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorios Sophia S.A de C.V.: lead

Study Sites (3)

catarata y glaucoma de occidente S.A de C.V.

Guadalajara, Jalisco, 44160, Mexico

Location

Novam y Vita

Guadalajara, Jalisco, 44620, Mexico

Location

Consultorio PRivado Miguel Angel Villanueva

Mexico City, 06700, Mexico

Location

MeSH Terms

Conditions

Pterygium; Eye Pain

Interventions

bromfenac

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Eye Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Results Point of Contact

• Title: PhD. Ricardo Llamas
• Organization: Laboratorios Sophia

ricardo.llamas@sophia.com.mx

+52 (33) 3001 4200

Study Officials

• Leopoldo Baiza Durán, MD

  Laboratorios Sophia S.A de C.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 11, 2018
• Study Start: December 13, 2017
• Primary Completion: September 14, 2018
• Study Completion: October 31, 2018
• Last Updated: November 20, 2019
• Results First Posted: November 20, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (3)