Dry EyePhase 1PRO-167/INCT03520348
Safety and Tolerability of the Ophthalmic Gel PRO-167 Versus Corneregel® on Healthy Subjects.
A Phase 1 study testing PRO-167 and Corneregel in people with Dry Eye and Dry Eye Syndrome of Unspecified Lacrimal Gland, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial summary
Title of the study: Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic gel PRO-167 versus Corneregel®, on the ocular surface of ophthalmological and clinically healthy subjects. Methodology: Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory. 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, Dry Eye Syndrome of Unspecified Lacrimal Gland
- What is being tested?
- PRO-167 and Corneregel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteMexico
- Study dates
- 4 Oct 2017to 16 Jul 2018
- 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, blood chemistry of three elements 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.
- 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 breastfeeding.
- Women without a history of hysterectomy, oophorectomy, 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.
Show all 11Show fewer
- Diagnosis of liver disease or triple the normal upper value of any of the following liver enzymes: aspartate transferase (AST), alanine transferase (ALT) or bilirubin.
- Inability to attend or answer the evaluations made in each of the visits.
- Positive smoking (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
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-167 Versus Corneregel®, on the Ocular Surface of Ophthalmological and Clinically Healthy Subjects.
Title of the study:
Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic gel PRO-167 versus Corneregel®, on the ocular surface of ophthalmological and clinically healthy subjects.
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Goals:
To evaluate the safety and tolerability of the ophthalmic gel PRO-167 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
Ophthalmic gel PRO-167 has a safety and tolerability profile similar to that of its comparator in healthy subjects.
Read the detailed description
Therapeutic indication:
Corneal surface reepithelizing
Statistical methodology:
The data will be expressed with measures of central tendency: mean and standard deviation for the quantitative variables. The qualitative variables will be presented in frequencies and percentages. The statistical analysis will be carried out through the Mann-Whitney U test for quantitative variables. The difference between the qualitative variables will be analyzed by means of square chi (Chi2). An alpha ≤ 0.05 will be considered significant.
Study period:
3 to 4 months
Development phase: I
Number of patients:
24 subjects, divided into 2 groups (12 eyes exposed per group)
Test product, dose and route of administration, lot number:
PRO-167. Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico.
- Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.
- Route of administration: ophthalmic.
Reference product, dose and route of administration, lot:
- Corneregel. Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany.
- Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.
- Route of administration: ophthalmic
Evaluation criteria:
Primary security outcome variable:
- Density of goblet cells.
Secondary security variables:
- Epithelial defects in cornea and conjunctiva.
- Presence of adverse events.
Secondary outcome variables:
- Intraocular pressure.
- Visual ability
- Break time of the tear film.
Outcome variables of tolerability:
- Burning.
- Foreign body sensation.
- Itching.
- Eye comfort index.
- Being tested
- PRO-167, Corneregel
- Keywords
- dry eye, eye lubricants, eye lubricant gel, PRO-167
- 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-167Drug
Also called dexpanthenol
Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Route of administration: ophthalmic
CorneregelDrug
Also called dexpanthenol
Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany. Route of administration: ophthalmic
| Study group | Role | What they receive |
|---|---|---|
| PRO-167 | Experimental | Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom Receives: Drug: PRO-167 |
| Corneregel® | Active comparator | Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac. Receives: Drug: Corneregel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goblet Cell Density (GCD)
the cells will be measured per square millimeter, it is a continuous variable taken by means of cytology per impression, the normal value is higher than 500 cells per square millimeter
Measured: will be evaluated at the end of the treatment at the final visit (day 11)
Secondary outcomes (9)
Presence of Adverse Events (EAS)
the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent.
Measured: during the 11 days of evaluation, including the safety call (day 13).
Intraocular Pressure (IOP)
the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg
Measured: will be evaluated at the end of the treatment at the final visit (day 11)
Breakup Time (BUT)
breakup time lacrimal film 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 greater than 10 seconds.
Measured: will be evaluated at the end of the treatment at the final visit (day 11)
Chemosis
The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.
Measured: will be evaluated at the end of the treatment at the final visit (day 11)
Ocular Burning (OB)
ocular burning is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time.
Measured: will be evaluated at the end of the treatment at the final visit (day 11)
Epithelial Defects (ED)
The epithelial defects will be evaluated by means of two stains, green lissamine, 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.
Measured: will be evaluated at the end of the treatment at the final visit (day 11)
Conjunctival Hyperemia (CH)
Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.
Measured: will be evaluated at the end of the treatment at the final visit (day 11)
Foreign Body Sensation (FBS)
Foreign body sensation is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale:
Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.
Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time.
Measured: will be evaluated at the end of the treatment at the final visit (day 11)
Ocular Pruritus (P)
Ocular pruritus is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale:
Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.
Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time.
Measured: will be evaluated at the end of the treatment at the 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 posted9 May 2018
- Study start4 Oct 2017
- Primary completion22 May 2018
- Study completion16 Jul 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 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
- NCT03520348
- Sponsor's protocol ID
- SOPH167-0816/I
- Acronym
- PRO-167/I
- Status last verified
- May 2019
- First submitted
- 27 Apr 2018
- Last updated
- 19 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Munoz-Villegas P, Navarro-Sanchez AA, Sanchez-Rios A, Olvera-Montano O, Baiza-Duran LM. Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials. Ther Clin Risk Manag. 2021 Oct 21;17:1123-1134. doi: 10.2147/TCRM.S331294. eCollection 2021.
PubMed 34707360
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. 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-167 Versus Corneregel®, on the Ocular Surface of Ophthalmological and Clinically Healthy Subjects.
- ClinicalTrials.gov ID
- NCT03520348
- Acronym / sponsor ID
- PRO-167/I / SOPH167-0816/I
- Keywords
- dry eye, eye lubricants, eye lubricant gel, PRO-167
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 22 May 2018 (actual)
- Study completion
- 16 Jul 2018 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Posted 19 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Title of the study:
Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic gel PRO-167 versus Corneregel®, on the ocular surface of ophthalmological and clinically healthy subjects.
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Goals:
To evaluate the safety and tolerability of the ophthalmic gel PRO-167 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
Ophthalmic gel PRO-167 has a safety and tolerability profile similar to that of its comparator in healthy subjects.
Detailed description
Therapeutic indication:
Corneal surface reepithelizing
Statistical methodology:
The data will be expressed with measures of central tendency: mean and standard deviation for the quantitative variables. The qualitative variables will be presented in frequencies and percentages. The statistical analysis will be carried out through the Mann-Whitney U test for quantitative variables. The difference between the qualitative variables will be analyzed by means of square chi (Chi2). An alpha ≤ 0.05 will be considered significant.
Study period:
3 to 4 months
Development phase: I
Number of patients:
24 subjects, divided into 2 groups (12 eyes exposed per group)
Test product, dose and route of administration, lot number:
PRO-167. Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico.
- Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.
- Route of administration: ophthalmic.
Reference product, dose and route of administration, lot:
- Corneregel. Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany.
- Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.
- Route of administration: ophthalmic
Evaluation criteria:
Primary security outcome variable:
- Density of goblet cells.
Secondary security variables:
- Epithelial defects in cornea and conjunctiva.
- Presence of adverse events.
Secondary outcome variables:
- Intraocular pressure.
- Visual ability
- Break time of the tear film.
Outcome variables of tolerability:
- Burning.
- Foreign body sensation.
- Itching.
- Eye comfort index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
| Arm | Type | Receives |
|---|---|---|
| PRO-167 | Experimental | Drug: PRO-167Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom |
| Corneregel® | Active comparator | Drug: CorneregelDose: a strip approximately 1 cm long, 4 times a day during the period of vigil, 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, blood chemistry of three elements and liver function tests within normal parameters specified by the reference laboratory with a lower and upper margin of 10%.
Key exclusion criteria (11 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 breastfeeding.
- Women without a history of hysterectomy, oophorectomy, 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-167Also: dexpanthenolDexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico. Route of administration: ophthalmic | Drug | PRO-167 |
| CorneregelAlso: dexpanthenolDexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany. Route of administration: ophthalmic | Drug | Corneregel® |
Primary outcome
Goblet Cell Density (GCD)
Time frame: will be evaluated at the end of the treatment at the final visit (day 11)
the cells will be measured per square millimeter, it is a continuous variable taken by means of cytology per impression, the normal value is higher than 500 cells per square millimeter
9 secondary outcomes
Presence of Adverse Events (EAS)
Time frame: during the 11 days of evaluation, including the safety call (day 13).
Intraocular Pressure (IOP)
Time frame: will be evaluated at the end of the treatment at the final visit (day 11)
Breakup Time (BUT)
Time frame: will be evaluated at the end of the treatment at the final visit (day 11)
Chemosis
Time frame: will be evaluated at the end of the treatment at the final visit (day 11)
Ocular Burning (OB)
Time frame: will be evaluated at the end of the treatment at the final visit (day 11)
Epithelial Defects (ED)
Time frame: will be evaluated at the end of the treatment at the final visit (day 11)
Conjunctival Hyperemia (CH)
Time frame: will be evaluated at the end of the treatment at the final visit (day 11)
Foreign Body Sensation (FBS)
Time frame: will be evaluated at the end of the treatment at the final visit (day 11)
Ocular Pruritus (P)
Time frame: will be evaluated at the end of the treatment at the 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 19 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34707360Munoz-Villegas P, Navarro-Sanchez AA, Sanchez-Rios A, Olvera-Montano O, Baiza-Duran LM. Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials. Ther Clin Risk Manag. 2021 Oct 21;17:1123-1134. doi: 10.2147/TCRM.S331294. eCollection 2021.
- 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.
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-167 and Corneregel in people with Dry Eye and Dry Eye Syndrome of Unspecified Lacrimal Gland, 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 11 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 19 Jul 2019. 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 19 Jul 2019). 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?
Goblet Cell Density (GCD) (time frame: will be evaluated at the end of the treatment at the final visit (day 11)). 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 NCT03520348, which also lists 1 linked publication.
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 Jul 2019.