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
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
Connect with a study center
IIMET Investigación e Innovación en Medicina Traslacional
Guadalajara, Jalisco 44610
MexicoActive - Recruiting
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