Completed PHASE1 INTERVENTIONAL 3-arm NCT03524157

Safety and Tolerability of PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Healthy Subjects (PRO-087/I)

Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Ophthalmologically and Clinically Healthy Subjects

Sponsor: Laboratorios Sophia S.A de C.V.

Conditions Dry Eye Syndromes Lubricant Allergy Tear Disorder

Interventions PRO-087 Systane Ultra Xyel Ofteno

Updated 5 times since 2018 Last updated: May 9, 2019 Started: Jul 17, 2017 Primary completion: Feb 12, 2018 Completion: Mar 27, 2018

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Dry Eye Syndromes and Lubricant Allergy and is currently completed. Laboratorios Sophia S.A de C.V. leads this study, which shows 5 recorded versions since 2017 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Aug 2019 — Jan 2021 [monthly]

Completed PHASE1
Jun 2018 — Aug 2019 [monthly]

Completed PHASE1

First recorded

Jul 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Laboratorios Sophia S.A de C.V.

Data source: Laboratorios Sophia S.A de C.V.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Zapopan, Mexico