Study to Evaluate the Safety and Tolerability of PRO-231 Ophthalmic Solution Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects.

Last updated: April 11, 2024
Sponsor: Laboratorios Sophia S.A de C.V.
Overall Status: Active - Recruiting

Phase

1

Condition

Eye Disorders/infections

Allergy

Conjunctivitis, Bacterial

Treatment

PRO-231

VIGAMOXI®

Clinical Study ID

NCT06363292
SOPH231-1221/I
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a phase I clinical study evaluating the safety and tolerability of PRO-231 ophthalmic solution through the incidence of unexpected adverse events, incidence of conjunctival hyperemia and chemosis, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, compared to VIGAMOXI®.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Having the ability to voluntarily give their signed informed consent.
  • Ophthalmologically and clinically healthy subjects.
  • Being able to and willing to comply with scheduled visits, treatment plan, and otherstudy procedures.
  • Age between 18 to 45 years.
  • Male or female gender.
  • Women of childbearing potential who have not undergone Bilateral Tubal Occlusion (BTO [Tubal Ligation]), hysterectomy, or bilateral oophorectomy must ensure continuation (initiated ≥ 30 days prior to signing the informed consent form [ICF]) of the use of ahormonal contraceptive method or intrauterine device (IUD) during the study period.
  • Best corrected visual acuity (BCVA) of 20/30 or better in both eyes.
  • Corneal staining ≤ grade I on the Oxford Scale.
  • Having an intraocular pressure ≥ 10 and ≤ 21 mmHg.

Exclusion

Exclusion Criteria:

  • History of hypersensitivity to fluoroquinolones, steroid anti-inflammatories, or anyof the components of the drugs under investigation.
  • Use of ophthalmic medications from any pharmacological group.
  • Use of medications by any other route of administration.
  • Use of non-steroidal anti-inflammatory drugs, steroid anti-inflammatory drugs, orantibiotics by any route of administration in the last 30 days.
  • History of eye surgery in the last 6 months.
  • Use of contact lenses for a period less than two weeks prior to the start of thestudy, and during the intervention period of this study.
  • In the case of women: being pregnant, breastfeeding, or planning to become pregnantwithin the study period.
  • Having participated in any clinical research study 30 days prior to inclusion in thisstudy.
  • Having previously participated in this same study.
  • History of any chronic-degenerative disease, including Diabetes Mellitus or SystemicArterial Hypertension.
  • Diagnosis of glaucoma or ocular hypertension.
  • Known diagnosis of liver or heart disease.
  • Presenting active inflammatory or infectious disease at the time of entry into thestudy.
  • Presenting unresolved lesions or traumas at the time of entry into the study.
  • Having been subjected to non-ophthalmological surgical procedures in the last 3months.
  • Being or having an immediate family member (e.g., spouse, parent/legal guardian,sibling, or child) who is an employee of the research site or the sponsor, and whodirectly participates in this study.
  • Active smoking (specified as the consumption of cigarettes regardless of the amountand frequency, 4 weeks prior to study inclusion and during the intervention period ofthis study).
  • Active alcoholism (specified as the consumption of alcoholic beverages, regardless ofthe amount and frequency, 72 hours prior to study inclusion and during theintervention period of this study). Elimination Criteria
  • Withdrawal of their consent to participate in the study (informed consent form).
  • Occurrence of a serious adverse event, whether related or not to the interventions,that in the opinion of the principal investigator (PI) and/or the sponsor, couldaffect the patient's fitness to safely continue with the study procedures.
  • Non-tolerability or hypersensitivity to any of the compounds used during the tests -(fluorescein, tetracaine).
  • Non-tolerability or hypersensitivity to any of the drugs under investigation.
  • Adherence < 80% determined by the subject's diary and corroborated by the final weightof the research products (RP) compared to the initial weight.

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: PRO-231
Phase: 1
Study Start date:
January 30, 2024
Estimated Completion Date:
May 30, 2024

Study Description

This is a Phase I, controlled, comparative, parallel-group, single-blind, single-center, controlled clinical trial. The variables to be evaluated include:

Primary (safety):

  • Incidence of unexpected adverse events related to the interventions

  • Incidence of conjunctival hyperemia and chemosis

  • Changes in Best Corrected Visual Acuity (BCVA) assessed with Snellen chart

  • Changes in ocular surface integrity using fluorescein staining, using the standard Oxford scale.

Primary (tolerability):

  • Changes in the ocular comfort index (OCI) score

Secondary (safety):

  • Incidence of unexpected adverse events related to the interventions(excluding conjunctival hyperemia and/or chemosis).

Secondary (tolerability):

  • Presence of other ocular symptoms (burning, foreign body sensation, pruritus and lacrimation).

Connect with a study center

  • IIMET Investigación e Innovación en Medicina Traslacional

    Guadalajara, Jalisco 44610
    Mexico

    Active - Recruiting

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