Study to Evaluate the Safety and Tolerability of Pro-143 Ophthalmic Solution in Healthy Volunteers.
Overview
- Phase
- Phase 1
- Intervention
- PRO-143 Ophthalmic Solution
- Conditions
- Conjunctivitis, Bacterial
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Locations
- 1
- Primary Endpoint
- Conjunctival bulbar hyperemia
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
Study to evaluate the safety and tolerability of PRO-143 solution ophthalmic in healthy volunteers.
Detailed Description
A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of PRO-143 ophthalmic solution 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 systemics 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
PRO-143 Ophthalmic Solution
PRO-143 Ophthalmic Solution applied four times per day (c/6 hours) during 10 days.
Intervention: PRO-143 Ophthalmic Solution
Outcomes
Primary Outcomes
Conjunctival bulbar hyperemia
Time Frame: 10 days
Conjunctival hyperemia is defined as the simplest reaction of the conjunctiva to a stimulus, a red appearance secondary to the vasodilation of the conjunctival vessels of variable intensity. He will graduate using the Efron scale. 0 Normal , 1 Very slight, 2 Mild, 3 Moderate, 4 Severe.
Number of Participants with adverse events
Time Frame: 10 days
he evaluation of adverse events requires a questioning conducted by the principal investigator and the appropriate exploratory techniques for its detection. the number of adverse events per study group will be considered for the analysis
Secondary Outcomes
- Intraocular pressure (IOP)(10 days)
- Visual ability (VA)(10 days)
- Eye comfort index (ICO)(10 days)