Efficacy and Safety of PRO-155 on Inflammation of the Conjunctival Surface in Subjects With Grade… (NCT03521791) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of PRO-155 on Inflammation of the Conjunctival Surface in Subjects With Grade I-III Pterygium vs Placebo.
Mexico166 participantsStarted 2017-12-13
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Conjunctival Hyperemia (CH)
Timeframe: will be evaluated at the end of the treatment at the final visit (day 21)
2
Breakup Time (BUT)
Timeframe: will be evaluated at the end of the treatment at the final visit (day 21)