A Phase 4 interventional study of PRO-155 and Placebo in Pterygium, Ocular Pain and Ocular Inflammation, sponsored by Laboratorios Sophia S.A de C.V.. Completed at 3 sites in Mexico. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-11-20.
Sponsored by Laboratorios Sophia S.A de C.V. · Phase 4, Interventional, and Treatment
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.
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:
Group 2:
109 studies on the registry are indexed under Pterygium; 9 are open to participants now.
This study's enrollment of 166 is above the median of 60 across 93 interventional studies indexed under Pterygium.
Browse Pterygium studies →Laboratorios Sophia S.A de C.V. is the lead sponsor of 45 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac
Other: Placebo
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
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
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.
Time frame: 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.
Time frame: will be evaluated at the end of the treatment at the final visit (day 21)
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.
Time frame: will be evaluated at the end of the treatment at the final visit (day 21)
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
Time frame: will be evaluated at the end of the treatment at the final visit (day 21)
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
Time frame: will be evaluated at the end of the treatment at the final visit (day 36)
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.
Time frame: will be evaluated at the end of the treatment at the final visit (day 21)
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.
Time frame: will be evaluated at the end of the treatment at the final visit (day 21)
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.
Time frame: will be evaluated at the end of the treatment at the final visit (day 21)
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.
Time frame: will be evaluated at the end of the treatment at the final visit (day 21)
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.
Time frame: will be evaluated at the end of the treatment at the final visit (day 21)
| Milestone | PRO-155 | Placebo |
|---|---|---|
| Started | 76 | 90 |
| Completed | 69 | 73 |
| Not completed | 7 | 17 |
| Withdrew: Protocol violation | 7 | 17 |
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.
| eyes | PRO-155 | Placebo |
|---|---|---|
| Normal | 0 | 0 |
| Very mild | 39 | 29 |
| Mild | 25 | 36 |
| Moderate | 5 | 8 |
| Severe | 0 | 0 |
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.
| seconds | PRO-155 | Placebo |
|---|---|---|
| Breakup Time (BUT) | 8.29 ± 2.2 | 7.63 ± 2.3 |
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.
| eyes | PRO-155 | Placebo |
|---|---|---|
| Green lissamine grade 0 | 41 | 44 |
| Green lissamine grade 1 | 21 | 21 |
| Green lissamine grade 2 | 4 | 8 |
| Green lissamine grade 3 | 3 | 0 |
| Green lissamine grade 4 | 0 | 0 |
| Green lissamine grade 5 | 0 | 0 |
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
| mmHg | PRO-155 | Placebo |
|---|---|---|
| Intraocular Pressure (IOP) | 12.45 ± 2.1 | 13.08 ± 1.8 |
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
| Participants | PRO-155 | Placebo |
|---|---|---|
| Presence of Adverse Events (EAS) | 13 | 19 |
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.
| LogMAR | PRO-155 | Placebo |
|---|---|---|
| Visual Capacity | 0.043 ± 0.1 | 0.059 ± 0.2 |
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.
| eyes | PRO-155 | Placebo |
|---|---|---|
| Number of Eyes With Chemosis | 0 | 0 |
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.
| eyes | PRO-155 | Placebo |
|---|---|---|
| Number of Eyes With Foreign Body Sensation (FBS) | 10 | 18 |
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.
| eyes | PRO-155 | Placebo |
|---|---|---|
| Fluorescein Grade 0 | 31 | 31 |
| Fluorescein Grade 1 | 27 | 33 |
| Fluorescein Grade 2 | 11 | 9 |
| Fluorescein Grade 3 | 0 | 0 |
| Fluorescein Grade 4 | 0 | 0 |
| Fluorescein Grade 5 | 0 | 0 |
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.
| eyes | PRO-155 | Placebo |
|---|---|---|
| Number of Eyes With Ocular Burning (OB) | 8 | 11 |
Collected over Adverse events were monitored and recorded throughout the study, an average of 8 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PRO-155 | 0/76 (0%) | 0/76 (0%) | 13/76 (17.1%) |
| Placebo | 0/90 (0%) | 0/90 (0%) | 19/90 (21.1%) |
| Event | PRO-155 | Placebo |
|---|---|---|
| conjunctival hyperemiaEye disorders | 3/76 | 11/90 |
| ocular burningEye disorders | 5/76 | 5/90 |
| photophobiaEye disorders | 2/76 | 4/90 |
| Eye pruritusEye disorders | 0/76 | 3/90 |
| Foreign body sensation in eyesEye disorders | 2/76 | 3/90 |
| ocular painEye disorders | 0/76 | 2/90 |
| StyeEye disorders | 1/76 | 0/90 |
| HeadacheNervous system disorders | 1/76 | 0/90 |
| sore throatGeneral disorders | 1/76 | 0/90 |
| Corneal epithelium defectEye disorders | 1/76 | 0/90 |
| Age, Continuous(years) | PRO-155 | Placebo | Total |
|---|---|---|---|
| Mean | 53.8 ± 13.3 | 57.17 ± 14.4 | 55.51 ± 13.45 |
| Sex: Female, Male(Participants) | PRO-155 | Placebo | Total |
|---|---|---|---|
| Female | 30 | 30 | 60 |
| Male | 11 | 12 | 23 |
| Race (NIH/OMB)(Participants) | PRO-155 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 41 | 42 | 83 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Sep 2018, 9 months.
Results were first posted in Nov 2019, 1 year 2 months after primary completion.
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