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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)

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ClinicalTrials.gov Identifier: NCT03521791
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Laboratorios Sophia S.A de C.V.

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.


Condition or disease Intervention/treatment Phase
Pterygium Ocular Pain Ocular Inflammation Post-surgical Inflammation Drug: PRO-155 Other: Placebo Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
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.
Primary Purpose: Treatment
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.
Actual Study Start Date : December 13, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Bromfenac

Arm Intervention/treatment
Experimental: PRO-155
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

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 Names:
  • zebesten
  • bromfenac

Placebo Comparator: Placebo
Placebo 1 drop 2 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





Primary Outcome Measures :
  1. conjunctival hyperemia (CH) [ Time Frame: will be evaluated at the end of the treatment at the final visit (day 21) ]
    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.

  2. breakup time (BUT) [ Time Frame: will be evaluated at the end of the treatment at the final visit (day 21) ]
    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 :
  1. epithelial Defects (ED) [ Time Frame: will be evaluated at the end of the treatment at the final visit (day 21) ]
    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.

  2. Intraocular pressure (IOP) [ Time Frame: will be evaluated at the end of the treatment at the final visit (day 21) ]
    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

  3. presence of adverse events (EAS) [ Time Frame: will be evaluated at the end of the treatment at the final visit (day 36) ]
    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

  4. Visual capacity [ Time Frame: will be evaluated at the end of the treatment at the final visit (day 21) ]
    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.

  5. Chemosis [ Time Frame: will be evaluated at the end of the treatment at the final visit (day 21) ]
    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.

  6. Foreign body sensation (FBS) [ Time Frame: will be evaluated at the end of the treatment at the final visit (day 21) ]

    Foreign body sensation 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.



Other Outcome Measures:
  1. ocular burning (OB) [ Time Frame: will be evaluated at the end of the treatment at the final visit (day 21) ]

    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.




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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521791


Contacts
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Contact: Ricardo Llamas, PhD +52 (33) 3001 4200 ext 1259 ricardo.llamas@sophia.com.mx
Contact: Oscar Olvera, MD +52 (33) 3001 4200 ext 1074 oscar.olvera@sophia.com.mx

Locations
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Mexico
catarata y glaucoma de occidente S.A de C.V. Recruiting
Guadalajara, Jalisco, Mexico, 44160
Contact: Abraham Soto Gómez, MD    +5213312845937    dr_sotogomez@hotmail.com   
Contact: Elia Chavez Cedillo, MD    +5213336111939    dr.pchavez@gmail.com   
Novam y Vita Recruiting
Guadalajara, Jalisco, Mexico, 44620
Contact: Ruben Alfredo Suárez Velasco, MD    +5213331498410    rubensuarez@hotmail.com   
Contact: Rocio Sanchez García, MD    +521 3331498406    ro_chio187@hotmail.com   
Consultorio PRivado Miguel Angel Villanueva Recruiting
Ciudad de México, Mexico, 06700
Contact: Miguel Angel Villanueva Najera, MD    +5215539396514    mavn82@hotmail.com   
Contact: Sergio Herrero Herrera    +52155 3413 0149      
Sponsors and Collaborators
Laboratorios Sophia S.A de C.V.
Investigators
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Study Director: Leopoldo Baiza Durán, MD Laboratorios Sophia S.A de C.V.

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Responsible Party: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier: NCT03521791     History of Changes
Other Study ID Numbers: SOPH155-0415/IV
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Laboratorios Sophia S.A de C.V.:
zebesten
ocular anti-inflammatory
ocular analgesic
pterygium
anti-inflammatory non-steroidal ophthalmic

Additional relevant MeSH terms:
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Inflammation
Pterygium
Pathologic Processes
Conjunctival Diseases
Eye Diseases
Ophthalmic Solutions
Bromfenac
Anti-Inflammatory Agents
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents