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

Inflammation Clinical Trial

— PRO-155  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535443
• Other study ID #: BRON0611V1FI
• Status: Completed
• Phase: Phase 1
• Start date: September 2011
• Est. completion date: October 2011

Study information

• Verified date: October 2019
• Source: Laboratorios Sophia S.A de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Inflammation

Intervention

Drug:
• Bromfenac
Drug: Bromfenac Other names: PRO-155

Locations

Country	Name	City	State
Mexico	Unidad Medica "Grupo Pediátrico"	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Sophia S.A de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse Events	will be reported the presence of adverse events presented in the study group during the intervention period .	10 days
Secondary	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
Secondary	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
Secondary	Hyperemia	The red eye will be evaluated by the absence or presence of hyperemia.	10 days
Secondary	Burning	Eye ocular burning will be reported according to the following scale: absent, mild, moderate and severe.	10 days
Secondary	Tearing	Tearing will be reported according to the following scale: absent, mild, moderate and severe.	10 days
Secondary	Foreign Body Sensation	Foreign body sensation will be reported according to the following scale: absent, mild, moderate and severe.	10 days
Secondary	Photophobia	photophobia will be reported according to the following scale: absent, mild, moderate and severe.	10 days
Secondary	Chemosis	chemosis will be reported according to the following scale: absent, mild, moderate and severe.	10 days
Secondary	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
Secondary	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