SafetyPhase 1PRO-172NCT04693429

Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+

A Phase 1 study testing Bepotastine Besilate in people with Safety and Tolerability, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Clinical phase I, controlled, non comparative, open, single center study evaluating the safety and tolerability of ophthalmic solution PRO-172 when applied on the ocular surface of healthy volunteers. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Safety, Tolerability, Ocular Surface
What is being tested?: Bepotastine Besilate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteMexico
Study dates: 24 Sep 2020to 8 Dec 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Clinically healthy volunteers
Being capable of voluntarily grant a signed informed consent.
Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures.
Being between 18 and 45 years old.
Women in child-bearing age must assure the continuation (start ≥ 30 days prior to informed consent signing) of a hormonal contraceptive method of intrauterine device (IUD) during the study.
Having a best corrected visual acuity equal or better than 20/30 in both eyes.
Showing normal vital signs.
Having an intraocular pressure between 10 and 21 mmHg.

Who cannot join

Using any kind of ophthalmic topical product.
Using drugs or herbal products, through any administration route.
For women: pregnancy, breastfeeding or planning to become pregnant during the time of the study.
Having participated in clinical trials 90 days prior to inclusion in this study.
Having participated previously in this study.
Using contact lenses and not being able to suspend such use during the period of the study.

Show all 13Show fewer

Being unable to follow the lifestyle modification considerations required for the study.
Having started the use of hormonal contraceptives of IUD within 30 days previous of inclusion in this study.
Suffering any chronic degenerative diseases.
Suffering active inflammatory of infectious disease when entering this study.
Suffering unresolved lesions or traumas when entering this study.
Having a previous history of any kind of ocular surgery.
Having a previous history of any surgical procedure, non ophthalmological, within the last 3 months.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.
Guadalajara, Jalisco, 44190

Other trials in Mexico

About this study

Official title: Phase I Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution, Manufactured by Laboratorios Sophia, S.A. de C.V., When Applied on the Ocular Surface of Healthy Volunteers

Conditions: Safety, Tolerability, Ocular Surface, Ocular Comfort
Being tested: Bepotastine Besilate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bepotastine BesilateDrug
Also called PRO-172
Bepotastine Besilate 1.5% QID (quater in die) for 7 days

Study groups in NCT04693429
Study group	Role	What they receive
PRO-172	Experimental	PRO-172 Ophthalmic Solution QID (four times per day). Single arm. Receives: Drug: Bepotastine Besilate

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Related Unexpected Adverse Events (AE)
Presence/absence of related non expected adverse events
Measured: Day 10
Ocular Comfort Index
Ocular Comfort Index (OCI) Questionnaire for evaluation of dry eye symptoms in a scale from 0 to 100. Greater scores mean a worse outcome.
Measured: Day 8

Secondary outcomes (5)

Changes in Best Corrected Visual Acuity (BCVA)
Visual acuity (VA) is a test of visual function. It will be evaluated with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20.This score can be expressed in fraction (i.e. 20/20) decimal (i.e. 1.0), or LogMAR (i.e. 0) formats. In this study, VA is expressed in decimal format. In decimal format, a lower number is a worse outcome.
Measured: Baseline vs Day 8
Conjunctival and Corneal Staining With Lissamine Green
Conjunctival and corneal staining with lissamine green. The evaluation will take place after applying the lissamine green stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V).
Measured: Day 8
Conjunctival and Corneal Staining With Fluorescein
Conjunctival and corneal staining with fluorescein. The evaluation will take place after applying the fluorescein tain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V).
Measured: Day 8
Conjunctival Hyperemia
Rate of conjunctival hyperemia will be evaluated through the Efron scale which includes 5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (3), and Severe (4).
Measured: Day 8
Chemosis Incidence
Chemosis incidence will be evaluated at the end of the treatment at the final visit
Measured: Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 20208 Dec 2020

First posted5 Jan 2021
Study start24 Sep 2020
Primary completion27 Nov 2020
Study completion8 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SafetyStudies 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: Other
Allocation: Not applicable
Intervention model: Single group
Model description: Controlled, single center, non comparative
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04693429
Sponsor's protocol ID: SOPH172-0919/I
Acronym: PRO-172
Status last verified: Jul 2025
First submitted: 22 Dec 2020
Last updated: 16 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution, Manufactured by Laboratorios Sophia, S.A. de C.V., When Applied on the Ocular Surface of Healthy Volunteers
ClinicalTrials.gov ID: NCT04693429
Acronym / sponsor ID: PRO-172 / SOPH172-0919/I
Conditions: Safety, Tolerability, Ocular Surface, Ocular Comfort
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
Study start: 24 Sep 2020 (actual)
Primary completion: 27 Nov 2020 (actual)
Study completion: 8 Dec 2020 (actual)
First posted: 5 Jan 2021 (actual)
Results: Posted 16 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Controlled, single center, non comparative

Arm	Type	Receives
PRO-172	Experimental	Drug: Bepotastine BesilatePRO-172 Ophthalmic Solution QID (four times per day). Single arm.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Clinically healthy volunteers
Being capable of voluntarily grant a signed informed consent.
Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures.
Being between 18 and 45 years old.
Women in child-bearing age must assure the continuation (start ≥ 30 days prior to informed consent signing) of a hormonal contraceptive method of intrauterine device (IUD) during the study.

Key exclusion criteria (13 listed)

Using any kind of ophthalmic topical product.
Using drugs or herbal products, through any administration route.
For women: pregnancy, breastfeeding or planning to become pregnant during the time of the study.
Having participated in clinical trials 90 days prior to inclusion in this study.
Having participated previously 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
Bepotastine BesilateAlso: PRO-172Bepotastine Besilate 1.5% QID (quater in die) for 7 days	Drug	PRO-172

Primary outcome

Incidence of Related Unexpected Adverse Events (AE)
Time frame: Day 10
Presence/absence of related non expected adverse events
Ocular Comfort Index
Time frame: Day 8
Ocular Comfort Index (OCI) Questionnaire for evaluation of dry eye symptoms in a scale from 0 to 100. Greater scores mean a worse outcome.

5 secondary outcomes

Changes in Best Corrected Visual Acuity (BCVA)
Time frame: Baseline vs Day 8
Conjunctival and Corneal Staining With Lissamine Green
Time frame: Day 8
Conjunctival and Corneal Staining With Fluorescein
Time frame: Day 8
Conjunctival Hyperemia
Time frame: Day 8
Chemosis Incidence
Time frame: Day 8

Results and safety

Results posted to the registry on 16 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PRO-172	22	22

Primary outcome: Incidence of Related Unexpected Adverse Events (AE)

Time frame: Day 10. Number. Unit: Number of unexpected related AE

Measure	PRO-172 n = 22
Value	12

Population analysed: The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify adherence to stipulated procedures in the protocol.

Primary outcome: Ocular Comfort Index

Time frame: Day 8. Mean (Standard Deviation). Unit: score on a scale

Measure	PRO-172 n = 22
Value	17.70 (11.76)

Population analysed: The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From day 1 (basal visit) to the safety call on day 10 (± 1 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PRO-172	0 of 22 (0%)	17 of 22 (77.3%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bepotastine Besilate in people with Safety and Tolerability, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.

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 8 inclusion and 13 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: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 16 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Related Unexpected Adverse Events (AE) (time frame: Day 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04693429.

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 16 Jul 2025.