Dry EyePhase 1NCT06379685
Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface.
A Phase 1 study testing PRO-190 and Systane Ultra® in people with Dry Eye and Dry Eyes Chronic, run by Laboratorios Sophia S.A de C.V..
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye, Dry Eyes Chronic, Dry Eye Syndromes
- What is being tested?
- PRO-190 and Systane Ultra®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to 30 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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®.
Read the 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
- Conditions
- Dry Eye, Dry Eyes Chronic, Dry Eye Syndromes
- Being tested
- PRO-190, Systane Ultra®
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-190Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| PRO-190 | Experimental | 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. Receives: Drug: PRO-190 |
| Systane Ultra® | Active comparator | 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. Receives: Drug: Systane Ultra® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Unexpected Related Adverse Reactions
Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention.
Measured: 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 (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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].)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start30 Dec 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase I, controlled, comparative, controlled, comparative.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379685
- Sponsor's protocol ID
- SOPH190-0923/I
- Status last verified
- Mar 2025
- First submitted
- 15 Apr 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06379685
- Acronym / sponsor ID
- SOPH190-0923/I
- Conditions
- Dry Eye, Dry Eyes Chronic, Dry Eye Syndromes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase I, controlled, comparative, controlled, comparative.
| Arm | Type | Receives |
|---|---|---|
| PRO-190 | Experimental | Drug: PRO-190Propylene 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. |
| Systane Ultra® | Active comparator | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRO-190Propylene glycol 0.3% - Polyethylene glycol 400 0.3%. Ophthalmic solution. | Drug | PRO-190 |
| Systane Ultra®Propylene glycol 0.3% - Polyethylene glycol 400 0.4%. Ophthalmic solution. | Drug | Systane Ultra® |
Primary outcome
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.
6 secondary outcomes
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 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.
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.
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.
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 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRO-190 and Systane Ultra® in people with Dry Eye and Dry Eyes Chronic, run by Laboratorios Sophia S.A de C.V..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alejandra Sanchez-Rios, MD (33 3001 4200, alejandra.sanchez@sophia.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.