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

ConditionsDry EyeDry Eyes ChronicDry Eye Syndromes
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaboratorios Sophia S.A de C.V.

About this trial

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®.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PRO-190

    Drug

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

  • Systane Ultra®

    Drug

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

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: PRO-190Experimental treatment 1 intervention
Group B: Systane Ultra®Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence Unexpected Related Adverse Reactions

Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention.

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.

Secondary outcomes

1

Changes in the ocular comfort index (OCI) score in between interventions

Changes in the Ocular Comfort Index (OCI) score in between interventions, the subjects will be questioned regarding this symptoms' incidence.

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.
2

Changes in Best Corrected Visual Acuity (BCVA)

The BCVA will be evaluated through Snellen chart.

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.
3

Changes in tear film breakup time

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.

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.
4

Changes in intraocular pressure (IOP)

Previous instillation of topical anesthetic, the IOP will be measured through a Goldmann tonometer during visits.

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laboratorios Sophia S.A de C.V.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: