NCT01535443
Completed
Phase 1
Fase 1 Study to Evaluate the Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.
Overview
- Phase
- Phase 1
- Intervention
- Bromfenac
- Conditions
- Inflammation
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Visual Acuity
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.
Detailed 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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Bromfenac
Drug: Bromfenac ophthalmic solution 1 drop 4 times per day
Intervention: Bromfenac
Outcomes
Primary Outcomes
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
- Findings in Posterior Segment(10 days)
- Intraocular Pressure (IOP)(10 days)
- Hyperemia(10 days)
- Chemosis(10 days)
- Corneal Damage by Fluorescein Staining Test(10 days)
- Corneal Damage by Lissamine Green Staining Test(10 days)
- Burning(10 days)
- Tearing(10 days)
- Foreign Body Sensation(10 days)
- Photophobia(10 days)
- Adverse Events(10 days)
Study Sites (1)
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