Study Evaluating PRO-232 an Ophthalmic Solution Compared to Placebo. (NCT06352541) | Clinical Trial Compass
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 range18 Years – 45 Years
SexALL
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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…
What they're measuring
1
Incidence Unexpected Related Adverse Reactions
Timeframe: Days 0 (Basal Visit) 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)