CompletedPhase 1

Study Evaluating PRO-232 an Ophthalmic Solution Compared to Placebo.

Mexico28 participantsStarted 2024-02-08

Plain-language summary

This is a phase I study evaluating safety and tolerability through the incidence of unexpected adverse events and IOP measurement, as well as through the incidence of stinging after its administration, compared to placebo.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 other study 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 a hormonal 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 Criteria: * History of hypersensitivity to fluoroquinolones, steroid anti-inflammatories, or any of 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, or antibiotics 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 the study, and during the intervention period of this study. * In the case of women: being pregnant, breastfeeding…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence Unexpected Related Adverse Reactions

Timeframe: Days 0 (Basal Visit) 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)

Changes in intraocular pressure (IOP)

Timeframe: Days 0 (Basal Visit) 3 (Visit 1), 8 (Final Visit)

Incidence of Stinging

Timeframe: Days 0 (Basal Visit, 3 (Visit 1) and 8 (Final Visit)

Trial details

NCT IDNCT06352541

SponsorLaboratorios Sophia S.A de C.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-28

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