Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.

Study Overview
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Brief Summary
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Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.

Detailed Description
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A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.

Official Title
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Fase 1 Study to Evaluate the Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.

Conditions
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Inflammation, Cataract

Intervention / Treatment
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* Drug: Bromfenac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female. Age ≥ 18 years old at screening visit Exclusion Criteria: Any ocular or systemic condition. Patient with one blind eye. Visual acuity of 20/40 in any eye. Use of ocular or systemic medications. Contraindications or sensitivity to any component of the study treatments. Contact lens users. Ocular surgery within the past 3 months.. Women who were not using an effective means of contraception or who were pregnant or nursing. Participation in any studies of investigational drugs within 90 days previous to the inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bromfenac<br>Drug: Bromfenac ophthalmic solution 1 drop 4 times per day | Drug: Bromfenac<br>* Drug: Bromfenac Other names: PRO-155<br>* Other names: PROJECT SOPHIA PRO-155;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | A Snellen chart is an eye chart that can be used to measure visual acuity. consisting of a scale ranging from 20 to 200, where 20 is the best visual capacity and 200 is the worst | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | will be reported the presence of adverse events presented in the study group during the intervention period . | 10 days | 
| Findings in Posterior Segment | Abnormal bores will be reported when assessing the integrity of the posterior segment, the unit of measure will be number of findings. | 10 days | 
| Intraocular Pressure (IOP) | Intraocular pressure (IOP) measurement by applanation tonometry. The unit of measurement will be millimeters of mercury (mmhg) the normal range will be considered 11 to 21 mmhg. | 10 days | 
| Hyperemia | The red eye will be evaluated by the absence or presence of hyperemia. | 10 days | 
| Burning | Eye ocular burning will be reported according to the following scale: absent, mild, moderate and severe. | 10 days | 
| Tearing | Tearing will be reported according to the following scale: absent, mild, moderate and severe. | 10 days | 
| Foreign Body Sensation | Foreign body sensation will be reported according to the following scale: absent, mild, moderate and severe. | 10 days | 
| Photophobia | photophobia will be reported according to the following scale: absent, mild, moderate and severe. | 10 days | 
| Chemosis | chemosis will be reported according to the following scale: absent, mild, moderate and severe. | 10 days | 
| Corneal Damage by Fluorescein Staining Test | Corneal damage will be reported by Fluorescein eye staining using the following scale: absent, mild, moderate, and severe. | 10 days | 
| Corneal Damage by Lissamine Green Staining Test | Corneal damage will be reported by lissamine green staining using the following scale: absent, mild, moderate, and severe. | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRO-155, Ocular NSAIDs, Safety and tolerability, Ocular Inflammation, Ocular Paint