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

Laboratorios Sophia

Status and phase

Completed

Phase 4

Conditions

Ocular Pain

Post-surgical Inflammation

Pterygium

Ocular Inflammation

Treatments

Other: Placebo

Drug: PRO-155

Study type

Interventional

Funder types

Industry

Identifiers

NCT03521791

SOPH155-0415/IV

Details and patient eligibility

About

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.

Full 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

Enrollment

166 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.