Phase 4
N=166
Efficacy and Safety of PRO-155 on Inflammation of the Conjunctival Surface in Subjects With Grade I-III Pterygium vs Placebo.
Pterygium · Ocular Pain · Ocular Inflammation · Post-surgical Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT03521791 ↗Enrolled (actual)
166
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Conjunctival Hyperemia (CH) — 0; 0; 39; 29 eyes — p=0.133
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- PRO-155 (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Conjunctival Hyperemia (CH) |
0; 0; 39; 29; 25; 36 | 0.133 |
| PRIMARY Breakup Time (BUT) |
8.29; 7.63 | 0.045 sig |
| SECONDARY Epithelial Defects (ED) Green Lissamine |
41; 44; 21; 21; 4; 8 | 0.333 |
| SECONDARY Intraocular Pressure (IOP) |
12.45; 13.08 | 0.058 |
| SECONDARY Presence of Adverse Events (EAS) |
13; 19 | 0.394 |
| SECONDARY Visual Capacity |
0.043; 0.059 | 0.056 |
| SECONDARY Number of Eyes With Chemosis |
0; 0 | — |
| SECONDARY Number of Eyes With Foreign Body Sensation (FBS) |
10; 18 | 0.114 |
| SECONDARY Epithelial Defects (ED) Fluorescein Stain |
31; 31; 27; 33; 11; 9 | 0.117 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03521791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.