Clinical trial NCT03521791: Efficacy and Safety of PRO-155 on Inflammation of the Conjunctival Surface in Subjects With Grade I-III Pterygium vs Placebo.
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pterygium
Ocular Pain
Ocular Inflammation
Post-surgical Inflammation
Keywords: zebesten
ocular anti-inflammatory
ocular analgesic
pterygium
anti-inflammatory non-steroidal ophthalmic
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2018-05-11
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Conjunctival Hyperemia (CH)
timeFrame: will be evaluated at the end of the treatment at the final visit (day 21)
measure: Breakup Time (BUT)
timeFrame: will be evaluated at the end of the treatment at the final visit (day 21)
Secondary outcomes:
measure: Epithelial Defects (ED) Green Lissamine
timeFrame: will be evaluated at the end of the treatment at the final visit (day 21)
measure: Intraocular Pressure (IOP)
timeFrame: will be evaluated at the end of the treatment at the final visit (day 21)
measure: Presence of Adverse Events (EAS)
timeFrame: will be evaluated at the end of the treatment at the final visit (day 36)
measure: Visual Capacity
timeFrame: will be evaluated at the end of the treatment at the final visit (day 21)
measure: Number of Eyes With Chemosis
timeFrame: will be evaluated at the end of the treatment at the final visit (day 21)
measure: Number of Eyes With Foreign Body Sensation (FBS)
timeFrame: will be evaluated at the end of the treatment at the final visit (day 21)
measure: Epithelial Defects (ED) Fluorescein Stain
timeFrame: will be evaluated at the end of the treatment at the final visit (day 21)
Other outcomes:
measure: Number of Eyes With Ocular Burning (OB)
timeFrame: will be evaluated at the end of the treatment at the final visit (day 21)
Locations:
city: Guadalajara
country: Mexico
facility: catarata y glaucoma de occidente S.A de C.V.
state: Jalisco
city: Guadalajara
country: Mexico
facility: Novam y Vita
state: Jalisco
city: Ciudad de México
country: Mexico
facility: Consultorio PRivado Miguel Angel Villanueva
Study officials:
affiliation: Laboratorios Sophia S.A de C.V.
name: Leopoldo Baiza Durán, MD
role: STUDY_DIRECTOR
References: