Dry Eye SyndromesPhase 1PRO-165NCT03697876
Safety and Tolerability of the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel
A Phase 1 study testing PRO-165 and Artelac in people with Dry Eye Syndromes, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial summary
Objective: To assess the safety and tolerability of the PRO-165 formulation on the ocular surface of ophthalmologically and clinically healthy subjects. Hypothesis: Ophthalmic gel PRO-165 presents a safety and tolerability profile similar to Artelac® Nightime Gel in ophthalmological and clinically healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- PRO-165 and Artelac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteMexico
- Study dates
- 20 Aug 2018to 26 Jun 2024
- 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
- Signed informed consent.
- Systemically and ophthalmologically healthy subjects evaluated during the clinical history.
- Age between 18 to 45 years.
- Both genders.
- Blood tests (complete blood count, three element blood chemistry and liver function tests within normal parameters specified by the reference laboratory with a lower and upper margin of 10%)
- Vital signs within normal parameters. (Vital signs at rest: blood pressure ≤ 139/89 mmHg, heart rate 60 -100 beats per minute and respiratory rate of 12-24 breaths per minute)
- Visual capacity 20/30 or better, in both eyes.
- Intraocular pressure ≥11 and ≤ 21 mmHg.
Who cannot join
- Subjects with a history of hypersensitivity to any of the components of the research products.
- Subject users of topical ophthalmic medications of any pharmacological group.
- Subject users of medication by any other route of administration.
- Women who are pregnant or lactating.
- Women without a history of bilateral tubal obstruction, oophorectomy or hysterectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period.
- Subjects with participation in clinical research studies 90 days prior to inclusion in the present study.
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- Known diagnosis of liver disease
- Inability to attend or answer the evaluations made in each of the visits.
- Positive tobacco use (specified as cigarette consumption regardless of quantity and frequency)
- Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period).
- Contact lens users.
- Medical and therapeutic exclusion criteria.
- History of any chronic-degenerative disease.
- Inflammatory or infectious disease, active at the time of study entry.
- Injuries or traumatisms not resolved at the time of entry into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel, on the Ocular Surface of Ophthalmological and Clinically Healthy Subjects
Objective: To assess the safety and tolerability of the PRO-165 formulation on the ocular surface of ophthalmologically and clinically healthy subjects.
Hypothesis: Ophthalmic gel PRO-165 presents a safety and tolerability profile similar to Artelac® Nightime Gel in ophthalmological and clinically healthy subjects.
Phase I clinical study, controlled, of parallel groups, double blind, randomized, exploratory Therapeutic indication of PRO-165: Eye lubricant
Read the detailed description
The study subjects will be recruited from various research centers in western and central Mexico.
Each research center has a monitoring plan specified according to the recruitment capabilities of the same, which must be at least once a month, where the queries of your data entered into the electronic case report report will be reported to the center. (e-CRF) for which it has as time limit the next monitoring visit to make the pertinent changes.
The report of adverse events will be made according to the standard operating procedure (PNO) where it specifies, according to Official Mexican Standard 220 (NOM 220), that the signs or symptoms of adverse events will be reported based on the Medical Dictionary. for Regulatory Activities, for which the sponsor has version 20.1 in Spanish. For serious adverse events (SAEs) will be reported in accordance with the standardized operation procedure of pharmacovigilance of the sponsor, which adheres to the guidelines of NOM 220 and international regulations, these will be reported in the regulatory framework to the regulatory entity within a period of time no more than 7 days.
The study is registered in the National Registry of Clinical Trials (RNEC), entity equivalent to Clinical Trials in Mexico.
The quality assurance plan is carried out by the sponsor through the Quality Assurance agent in Clinical Research, whose function is to conduct inspections and audits of the research sites to document and generate reports of deviations from the protocol. In addition to the visits of the monitoring plan, the reliability of the data is guaranteed.
To verify the integrity, veracity and reliability of the data entered into the e-CRF, the monitors of each center will check the information uploaded to the portal with that reported in the source document of the principal investigator (PI), such as clinical notes, clinical history and documents. and formats attached to the research protocol, physical case report format, as well as those provided by the sponsor to the PI (subject's diary and quality and satisfaction survey).
The e-CRF used for this clinical study is provided by an internationally certified provider with the highest quality standards, protection of information under current regulations and confidentiality guarantee. The information that the PIs enter into the e-CRF is collated and verified by the clinical monitors and by the service provider's personnel, later reviewed and approved by the medical ophthalmologist researcher and by the Clinical Security Pharmacologist, who authorize the monitored data of clinical information and safety of the study molecule, respectively.
- Conditions
- Dry Eye Syndromes
- Being tested
- PRO-165, Artelac
- Keywords
- PRO-165, sodium hyaluronate, Chondroitin sulfate 0.18%
- 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-165Drug
Also called sodium hyaluronate 0.2%, chondroitin sulfate + sodium hyaluronate, chondroitin sulfate 0.18%
PRO-165 Chondroitin sulfate 0.18% / sodium hyaluronate 0.2%, ophthalmic gel. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
ArtelacDrug
Also called Carbomer 0.2%
Artelac® Nightime Gel. 0.2% Carbomer, ophthalmic gel. Made in Germany by: Dr. Gerhard Mann Chem Pharm. Imported and marketed by: Bausch \& Lomb México, S.A. de C.V.
| Study group | Role | What they receive |
|---|---|---|
| PRO-165 | Experimental | Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac Receives: Drug: PRO-165 |
| 1. Artelac® Nightime Gel | Active comparator | Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
The Principal Investigator will register the Events Adverse (EA) that the subjects of the study will present. The EAs will be expressed as absent or present and the number of cases will be counted by study group.
Measured: Throughout the 13 days of evaluation, including the safety call (day 13).
Ocular Comfort Index
It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100). A higher score is a worse outcome.
Similar to the index for ocular surface diseases, the ocular comfort index (ICO) evaluates symptoms. The ICO contains 6 items that focus on the discomfort associated with the ocular surface. Each of these questions has two parts, which inquire separately the frequency and severity of the symptoms.
The evaluator will deliver the questionnaire to the subject and allow the subject to answer it calmly without any pressure and / or coercion, will only assist him if he has difficulty understanding any of the questions.
Measured: Baseline Visit (day 0) and Final Visit (day 11)
Secondary outcomes (5)
Visual Acuity (VA)
Visual acuity (VA) is a test of visual function. It will be evaluated without refractive correction 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 both fraction (i.e. 20/20) or decimal (i.e. 0.5) formats. In this study, VA is expressed in fraction format.
Measured: Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11)
Intraocular Pressure (IOP)
Tonometry is the objective measure of Intraocular pressure, based primarily on the force required to flatten the cornea, or the degree of corneal indentation produced by a fixed force. Goldman's tonometry is based on the Imbert-Fick principle. the result will be expressed in millimeters of mercury and the comparison between groups will be carried out.
Measured: Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11).
Number of Participants With Post-instillation Symptomatology
The subject will be questioned if after applying the medication he felt burning, pruritus, a foreign body sensation and blurred vision.
Presence or absence: it will be marked as present (1) or absent (0) for each of the symptoms questioned
Measured: Final Visit (day 11)
Tear Breakup Time (TBUT)
Tear Breakup Time (TBUT) is a continuous variable that will be measured in seconds, evaluating the time it takes to break it, is done by direct counting and the normality range and mayor to 10 seconds.
Measured: Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11).
Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale)
The epithelial defects will be evaluated by means of two stains, lysamine green and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the Oxford Scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects. The outcome describes the number of pariticipants who presented which grade according to the Oxford Scale.
Measured: Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start20 Aug 2018
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
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 Dry Eye SyndromesStudies 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
- controlled, of parallel groups, double blind, randomized, exploratory
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leopoldo Baiza Durán, MD, Study director, Laboratorios Sophia S.A de C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697876
- Sponsor's protocol ID
- SOPH165-0217/I
- Acronym
- PRO-165
- Status last verified
- Dec 2025
- First submitted
- 3 Oct 2018
- Last updated
- 9 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The principal investigator must request the authorization of the sponsor in writing to disseminate or communicate any type of information about the investigation.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. 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 the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel, on the Ocular Surface of Ophthalmological and Clinically Healthy Subjects
- ClinicalTrials.gov ID
- NCT03697876
- Acronym / sponsor ID
- PRO-165 / SOPH165-0217/I
- Conditions
- Dry Eye Syndromes
- Keywords
- PRO-165, sodium hyaluronate, Chondroitin sulfate 0.18%
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Posted 9 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To assess the safety and tolerability of the PRO-165 formulation on the ocular surface of ophthalmologically and clinically healthy subjects.
Hypothesis: Ophthalmic gel PRO-165 presents a safety and tolerability profile similar to Artelac® Nightime Gel in ophthalmological and clinically healthy subjects.
Phase I clinical study, controlled, of parallel groups, double blind, randomized, exploratory Therapeutic indication of PRO-165: Eye lubricant
Detailed description
The study subjects will be recruited from various research centers in western and central Mexico.
Each research center has a monitoring plan specified according to the recruitment capabilities of the same, which must be at least once a month, where the queries of your data entered into the electronic case report report will be reported to the center. (e-CRF) for which it has as time limit the next monitoring visit to make the pertinent changes.
The report of adverse events will be made according to the standard operating procedure (PNO) where it specifies, according to Official Mexican Standard 220 (NOM 220), that the signs or symptoms of adverse events will be reported based on the Medical Dictionary. for Regulatory Activities, for which the sponsor has version 20.1 in Spanish. For serious adverse events (SAEs) will be reported in accordance with the standardized operation procedure of pharmacovigilance of the sponsor, which adheres to the guidelines of NOM 220 and international regulations, these will be reported in the regulatory framework to the regulatory entity within a period of time no more than 7 days.
The study is registered in the National Registry of Clinical Trials (RNEC), entity equivalent to Clinical Trials in Mexico.
The quality assurance plan is carried out by the sponsor through the Quality Assurance agent in Clinical Research, whose function is to conduct inspections and audits of the research sites to document and generate reports of deviations from the protocol. In addition to the visits of the monitoring plan, the reliability of the data is guaranteed.
To verify the integrity, veracity and reliability of the data entered into the e-CRF, the monitors of each center will check the information uploaded to the portal with that reported in the source document of the principal investigator (PI), such as clinical notes, clinical history and documents. and formats attached to the research protocol, physical case report format, as well as those provided by the sponsor to the PI (subject's diary and quality and satisfaction survey).
The e-CRF used for this clinical study is provided by an internationally certified provider with the highest quality standards, protection of information under current regulations and confidentiality guarantee. The information that the PIs enter into the e-CRF is collated and verified by the clinical monitors and by the service provider's personnel, later reviewed and approved by the medical ophthalmologist researcher and by the Clinical Security Pharmacologist, who authorize the monitored data of clinical information and safety of the study molecule, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- controlled, of parallel groups, double blind, randomized, exploratory
| Arm | Type | Receives |
|---|---|---|
| PRO-165 | Experimental | Drug: PRO-165Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac |
| 1. Artelac® Nightime Gel | Active comparator | –Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signed informed consent.
- Systemically and ophthalmologically healthy subjects evaluated during the clinical history.
- Age between 18 to 45 years.
- Both genders.
- Blood tests (complete blood count, three element blood chemistry and liver function tests within normal parameters specified by the reference laboratory with a lower and upper margin of 10%)
Key exclusion criteria (15 listed)
- Subjects with a history of hypersensitivity to any of the components of the research products.
- Subject users of topical ophthalmic medications of any pharmacological group.
- Subject users of medication by any other route of administration.
- Women who are pregnant or lactating.
- Women without a history of bilateral tubal obstruction, oophorectomy or hysterectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period.
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-165Also: sodium hyaluronate 0.2%, chondroitin sulfate + sodium hyaluronate, chondroitin sulfate 0.18%PRO-165 Chondroitin sulfate 0.18% / sodium hyaluronate 0.2%, ophthalmic gel. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. | Drug | PRO-165 |
| ArtelacAlso: Carbomer 0.2%Artelac® Nightime Gel. 0.2% Carbomer, ophthalmic gel. Made in Germany by: Dr. Gerhard Mann Chem Pharm. Imported and marketed by: Bausch \& Lomb México, S.A. de C.V. | Drug | – |
Primary outcome
Adverse Events
Time frame: Throughout the 13 days of evaluation, including the safety call (day 13).
The Principal Investigator will register the Events Adverse (EA) that the subjects of the study will present. The EAs will be expressed as absent or present and the number of cases will be counted by study group.
Ocular Comfort Index
Time frame: Baseline Visit (day 0) and Final Visit (day 11)
It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100). A higher score is a worse outcome. Similar to the index for ocular surface diseases, the ocular comfort index (ICO) evaluates symptoms. The ICO contains 6 items that focus on the discomfort associated with the ocular surface. Each of these questions has two parts, which inquire separately the frequency and severity of the symptoms. The evaluator will deliver the questionnaire to the subject and allow the subject to answer it calmly without any pressure and / or coercion, will only assist him if he has difficulty understanding any of the questions.
5 secondary outcomes
Visual Acuity (VA)
Time frame: Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11)
Intraocular Pressure (IOP)
Time frame: Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11).
Number of Participants With Post-instillation Symptomatology
Time frame: Final Visit (day 11)
Tear Breakup Time (TBUT)
Time frame: Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11).
Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale)
Time frame: Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The principal investigator must request the authorization of the sponsor in writing to disseminate or communicate any type of information about the investigation.
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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.
Leopoldo Baiza Durán, MD study director
Laboratorios Sophia S.A de C.V.
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 PRO-165 and Artelac in people with Dry Eye Syndromes, 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 15 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 9 Jan 2026. 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 9 Jan 2026). 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?
Adverse Events (time frame: Throughout the 13 days of evaluation, including the safety call (day 13).). 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?
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 9 Jan 2026.