Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface.

March 18, 2025 updated by: Laboratorios Sophia S.A de C.V.

Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface of Ophthalmologically and Clinically Healthy Volunteers.

This is a phase I clinical study to evaluate the safety and tolerability of PRO-190 ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, changes in the ocular comfort index (OCI) score, and IOP measurement compared to Systane Ultra®.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The variables to be evaluated include:

Primary (safety):

Incidence Unexpected Related Adverse Reactions

Secondary:

Changes in the ocular comfort index (OCI) score in between interventions Changes in Best Corrected Visual Acuity (BCVA) Changes in tear film breakup time Changes in intraocular pressure (IOP) Changes in the integrity of the ocular surface (fluorescein staining) Changes in lissamine green staining

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Having the ability to voluntarily give their signed informed consent.
  • Clinically healthy subjects.
  • Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.
  • Age ≥ 18 years.
  • No history of contact lens wear
  • 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 ied consent form [ICF]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
  • Having vital signs within normal parameters.
  • Best corrected visual acuity (BCVA) of 20/30 or better in both eyes.
  • Having an intraocular pressure ≥ 10 and ≤ 21 mmHg.

Exclusion Criteria:

  • History of hypersensitivity to 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.
  • In the case of women: being pregnant, breastfeeding, or planning to become pregnant within the study period.
  • Having participated in any clinical research study 30 days prior to inclusion in this study.
  • Having previously participated in this same study.
  • History of any chronic-degenerative disease, including Diabetes Mellitus or Systemic Arterial 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 the study.
  • Presenting unresolved lesions or traumas at the time of entry into the study.
  • Having been subjected to non-ophthalmological surgical procedures in the last 3 months.
  • 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 who directly participates in 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, could affect 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 weight of the research products (RP) compared to the initial weight.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRO-190

Propylene glycol 0.3% - Polyethylene glycol 400 0.3%. Ophthalmic solution.

Dosage: 1 drop QID [4] (4 times per day, at least three hours apart between doses) for 7 days in both eyes,

Route of administration: Ophthalmic.
Drug: PRO-190
Propylene glycol 0.3% - Polyethylene glycol 400 0.3%. Ophthalmic solution.
Active Comparator: Systane Ultra®

Propylene glycol 0.3% - Polyethylene glycol 400 0.4%. Ophthalmic solution.

Dosage: 1 drop QID [4] (4 times per day, at least three hours apart between doses) for 7 days in both eyes,

Route of administration: Ophthalmic.
Drug: Systane Ultra®
Propylene glycol 0.3% - Polyethylene glycol 400 0.4%. Ophthalmic solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Unexpected Related Adverse Reactions
Time Frame: Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), 8 (Final Visit) and 12 (Safety Call) after the inclusion of each subject.
Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention.
Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), 8 (Final Visit) and 12 (Safety Call) after the inclusion of each subject.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the ocular comfort index (OCI) score in between interventions
Time Frame: Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.
Changes in the Ocular Comfort Index (OCI) score in between interventions, the subjects will be questioned regarding this symptoms' incidence.
Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.
Changes in Best Corrected Visual Acuity (BCVA)
Time Frame: Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.
The BCVA will be evaluated through Snellen chart.
Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.
Changes in tear film breakup time
Time Frame: Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.
The most common method for assessing stability is with fluorescein. The precorneal layer colored with fluorescein will change to less fluorescent or non-fluorescent regions. The time from the last blink to the appearance of these regions is the tear film breakup time.
Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.
Changes in intraocular pressure (IOP)
Time Frame: Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.
Previous instillation of topical anesthetic, the IOP will be measured through a Goldmann tonometer during visits.
Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.
Changes in the integrity of the ocular surface (fluorescein staining)
Time Frame: Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.
Changes in the integrity of the ocular surface using fluorescein staining and evaluated through the Oxford scale. The standard Oxford scale for fluorescein staining has the following criteria: Grade 0- Equal to or less than panel A; Grade I- Equal to or less than panel B, greater than panel A; Grade II- Equal to or less than panel C, greater than panel B; Grade III- Equal or less than panel D, greater than panel C; Grade IV- Equal or less than panel E, greater than panel D; Grade V- Greater than panel E.
Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.
Changes in lissamine green staining
Time Frame: Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.
Direct observation with slit lamp, graded according to (changes in ocular surface staining using the Sjögren's International Collaborative Clinical Alliance [SICCA].)
Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Sophia S.A de C.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 30, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOPH190-0923/I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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