A Phase 1 interventional study of PRO-190 and Systane Ultra® in Dry Eye, Dry Eyes Chronic and Dry Eye Syndromes, sponsored by Laboratorios Sophia S.A de C.V.. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by Laboratorios Sophia S.A de C.V. · Phase 1, Interventional, and Treatment
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®.
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
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's planned enrollment of 32 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Laboratorios Sophia S.A de C.V. is the lead sponsor of 45 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Elimination Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 0.4%. 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 0.3%. Ophthalmic solution.
Propylene glycol 0.3% - Polyethylene glycol 400 0.4%. Ophthalmic solution.
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.
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.
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.
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.
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.
Changes in the integrity of the ocular surface (fluorescein staining)
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.
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 lissamine green staining
Direct observation with slit lamp, graded according to (changes in ocular surface staining using the Sjögren's International Collaborative Clinical Alliance \[SICCA\].)
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.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2025; primary completion for Dec 2026, 12 months later.
Of 34 phase 1 interventional studies under Dry Eye Syndromes, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 13. This study's planned 12 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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