Skip to main content
OpenTrials
Completed

NCT Number: NCT01535443

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Inflammation Cataract Eye Diseases Lens Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Unidad Medica "Grupo Pediátrico"

Guadalajara, Jalisco, 44690, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bromfenac

Drug

Drug: Bromfenac Other names: PRO-155

Other names: PROJECT SOPHIA PRO-155

Primary outcomes

  1. Visual Acuity

    Time frame: 10 days

    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

Secondary outcomes

  1. Adverse Events

    Time frame: 10 days

    will be reported the presence of adverse events presented in the study group during the intervention period .

  2. Findings in Posterior Segment

    Time frame: 10 days

    Abnormal bores will be reported when assessing the integrity of the posterior segment, the unit of measure will be number of findings.

  3. Intraocular Pressure (IOP)

    Time frame: 10 days

    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.

  4. Hyperemia

    Time frame: 10 days

    The red eye will be evaluated by the absence or presence of hyperemia.

  5. Burning

    Time frame: 10 days

    Eye ocular burning will be reported according to the following scale: absent, mild, moderate and severe.

  6. Tearing

    Time frame: 10 days

    Tearing will be reported according to the following scale: absent, mild, moderate and severe.

  7. Foreign Body Sensation

    Time frame: 10 days

    Foreign body sensation will be reported according to the following scale: absent, mild, moderate and severe.

  8. Photophobia

    Time frame: 10 days

    photophobia will be reported according to the following scale: absent, mild, moderate and severe.

  9. Chemosis

    Time frame: 10 days

    chemosis will be reported according to the following scale: absent, mild, moderate and severe.

  10. Corneal Damage by Fluorescein Staining Test

    Time frame: 10 days

    Corneal damage will be reported by Fluorescein eye staining using the following scale: absent, mild, moderate, and severe.

  11. Corneal Damage by Lissamine Green Staining Test

    Time frame: 10 days

    Corneal damage will be reported by lissamine green staining using the following scale: absent, mild, moderate, and severe.

Sponsors and collaborators

Lead sponsor

Laboratorios Sophia S.A de C.V.

Industry

Registry information

Official study title

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

Acronym: PRO-155

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 17, 2012
Registry last updated
Oct 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.