ConjunctivitisPhase 1PRO-174/INCT03519516
Safety and Tolerability of the PRO-174 Versus Sophixín Ofteno®, on the Ocular Surface of Healthy Subjects
A Phase 1 study testing PRO-174 and Sophixín Ofteno® in people with Conjunctivitis and Conjunctivitis, Bacterial, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial summary
Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution PRO-174 versus Sophixín Ofteno®, elaborated by Laboratorios Sophia, S.A. of C.V. on the ocular surface of ophthalmologically 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
- Conjunctivitis, Conjunctivitis, Bacterial
- What is being tested?
- PRO-174 and Sophixín Ofteno®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 25 Jan 2018to 10 Jun 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. (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
- General criteria
- 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.
- Pregnant or lactating women.
- Women of childbearing age, who do not ensure a hormonal contraceptive method or intrauterine device during the study period or without a history of bilateral tubal obstruction, oophorectomy or hysterectomy; as fertile age we understand women who have not had their menopause, defined as 12 months since the last menstruation in women over 40 years.
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- Subjects with participation in clinical research studies 90 days prior to inclusion in the present study.
- Diagnosis of liver disease or elevation to three times 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 amount and frequency)
- Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period).
- Contact lens users.
- An occlusive iridocorneal angle, defined as a trabecular mesh visible at less than 90 ° from the angular circumference to gonioscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Trial, to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-174 Versus Sophixín Ofteno®, Elaborated by Laboratorios Sophia on the Ocular Surface of Ophthalmological and Clinically Healthy Subjects
Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution PRO-174 versus Sophixín Ofteno®, elaborated by Laboratorios Sophia, S.A. of C.V. on the ocular surface of ophthalmologically and clinically healthy subjects.
Goals:
To evaluate the safety and tolerability of the formulation PRO-174 manufactured by Laboratorios Sophia, S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
The ophthalmic solution PRO-174 presents a safety and tolerability profile similar to the comparator in healthy subjects.
Read the detailed description
Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution PRO-174 versus Sophixín Ofteno®, elaborated by Laboratorios Sophia, S.A. of C.V. on the ocular surface of ophthalmologically and clinically healthy subjects.
Goals:
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Number of patients:
30 subjects, divided into 2 groups [15 subjects (30 eyes) exposed per group]
Test product, dose and route of administration, lot number:
- PRO-174. Levofloxacin 0.5% ophthalmic solution. Prepared by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
- Dosage: 1 drop every 2 hours during the waking period (8 daily applications), on day 1 and 2; continuing with 1 drop every 4 hours during the waking period (4 daily applications) from day 3 to 7. Both eyes.
- Route of administration: ophthalmic
Duration of treatment: 7 days
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 the quantitative variables for the difference between the groups. The intra-group difference will be made with the Wilcoxon rank test. The difference between the qualitative variables will be analyzed by means of X2 (Chi2). An alpha ≤ 0.05 will be considered significant.
- Conditions
- Conjunctivitis, Conjunctivitis, Bacterial
- Being tested
- PRO-174, Sophixín Ofteno®
- Keywords
- ocular antibiotic, quinolone, levofloxacin, ophthalmic antibiotic, antibiotic in drops
- Medical subject headings
- Conjunctivitis, Conjunctivitis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-174Drug
Also called PRO174, Levofloxacin Ophthalmic Solution
Pharmaceutical form: ophthalmic solution
- Prepared by: Laboratorios Sophia, S.A. of C.V.
- Description of the solution: transparent solution, free of visible particles.
- Description of container: sterile multi-dose bottle
Sophixín Ofteno®Drug
Also called Ciprofloxacin Ophthalmic solution
- Active substance: Ciprofloxacin 0.3%
- Pharmaceutical form: Ophthalmic solution
- Prepared by: Laboratorios Sophia, S.A. of C.V.
- Description of the solution: transparent solution, free of visible particles.
- Description of container: sterile multi-dose bottle
| Study group | Role | What they receive |
|---|---|---|
| PRO-174 | Experimental | Active ingredient: Levofloxacin 0.5%
o Dosage: 1 drop in both eyes, 8 times a day during the waking period Receives: Drug: PRO-174 |
| Sophixín Ofteno® | Active comparator | o Dosage: 1 drop in both eyes, 8 times a day during the waking period Receives: Drug: Sophixín Ofteno® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events (EAS)
primary security variable 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 12 days of evaluation, including the safety call (day 12).
Ocular Burning (OB)
primary tolerability variable
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.
Measured: will be evaluated at the end of the treatment at the final visit (day 7)
Secondary outcomes (8)
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 7)
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 and mayor to 10 seconds.
Measured: will be evaluated at the end of the treatment at the final visit (day 7)
Number of Eyes With Epithelial Defects (ED) by Grade
The epithelial defects will be evaluated by means of two stains, green lysine 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.
Measured: will be evaluated at the end of the treatment at the final visit (day 7)
Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade
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 7)
Number of Eyes With Foreign Body Sensation (FBS) by Grade
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.
Measured: will be evaluated at the end of the treatment at the final visit (day 7)
Number of Eyes With Ocular Pruritus (P) by Grade
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.
Measured: will be evaluated at the end of the treatment at the final visit (day 7)
Number of Eyes of 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 7)
Visual Capacity
The visual capacity variable will be reported using as a unit of measure a fraction, this is taken from a visual test with the Snellen primer, it is a Nominal type variable. where the optimal vision is 20/20 and higher scores indicate worse visual acuity.
Snellen Scale: 20/200, 20/100, 20/70, 20/50, 20/40, 20/30, 20/25, 20/20, 20/15, 20/12, 20/10
only the denominator of the fraction of each case is reported and averaged per group.
Measured: will be evaluated at the end of the treatment at the final visit (day 7)
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 start25 Jan 2018
- Primary completion25 May 2018
- Study completion10 Jun 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 ConjunctivitisStudies 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
- 30 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
- NCT03519516
- Sponsor's protocol ID
- SOPH174-0816/I
- Acronym
- PRO-174/I
- Status last verified
- Oct 2019
- First submitted
- 26 Apr 2018
- Last updated
- 25 Oct 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 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial, to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-174 Versus Sophixín Ofteno®, Elaborated by Laboratorios Sophia on the Ocular Surface of Ophthalmological and Clinically Healthy Subjects
- ClinicalTrials.gov ID
- NCT03519516
- Acronym / sponsor ID
- PRO-174/I / SOPH174-0816/I
- Conditions
- Conjunctivitis, Conjunctivitis, Bacterial
- Keywords
- ocular antibiotic, quinolone, levofloxacin, ophthalmic antibiotic, antibiotic in drops
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 10 Jun 2018 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Posted 25 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution PRO-174 versus Sophixín Ofteno®, elaborated by Laboratorios Sophia, S.A. of C.V. on the ocular surface of ophthalmologically and clinically healthy subjects.
Goals:
To evaluate the safety and tolerability of the formulation PRO-174 manufactured by Laboratorios Sophia, S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
The ophthalmic solution PRO-174 presents a safety and tolerability profile similar to the comparator in healthy subjects.
Detailed description
Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution PRO-174 versus Sophixín Ofteno®, elaborated by Laboratorios Sophia, S.A. of C.V. on the ocular surface of ophthalmologically and clinically healthy subjects.
Goals:
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Number of patients:
30 subjects, divided into 2 groups [15 subjects (30 eyes) exposed per group]
Test product, dose and route of administration, lot number:
- PRO-174. Levofloxacin 0.5% ophthalmic solution. Prepared by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
- Dosage: 1 drop every 2 hours during the waking period (8 daily applications), on day 1 and 2; continuing with 1 drop every 4 hours during the waking period (4 daily applications) from day 3 to 7. Both eyes.
- Route of administration: ophthalmic
Duration of treatment: 7 days
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 the quantitative variables for the difference between the groups. The intra-group difference will be made with the Wilcoxon rank test. The difference between the qualitative variables will be analyzed by means of X2 (Chi2). An alpha ≤ 0.05 will be considered significant.
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-174 | Experimental | Drug: PRO-174Active ingredient: Levofloxacin 0.5% o Dosage: 1 drop in both eyes, 8 times a day during the waking period |
| Sophixín Ofteno® | Active comparator | Drug: Sophixín Ofteno®o Dosage: 1 drop in both eyes, 8 times a day during the waking period |
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 (13 listed)
- General criteria
- 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.
- Pregnant or lactating women.
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-174Also: PRO174, Levofloxacin Ophthalmic SolutionPharmaceutical form: ophthalmic solution * Prepared by: Laboratorios Sophia, S.A. of C.V. * Description of the solution: transparent solution, free of visible particles. * Description of container: sterile multi-dose bottle | Drug | PRO-174 |
| Sophixín Ofteno®Also: Ciprofloxacin Ophthalmic solution* Active substance: Ciprofloxacin 0.3% * Pharmaceutical form: Ophthalmic solution * Prepared by: Laboratorios Sophia, S.A. of C.V. * Description of the solution: transparent solution, free of visible particles. * Description of container: sterile multi-dose bottle | Drug | Sophixín Ofteno® |
Primary outcome
Number of Adverse Events (EAS)
Time frame: during the 12 days of evaluation, including the safety call (day 12).
primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent.
Ocular Burning (OB)
Time frame: will be evaluated at the end of the treatment at the final visit (day 7)
primary tolerability variable 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.
8 secondary outcomes
Intraocular Pressure (IOP)
Time frame: will be evaluated at the end of the treatment at the final visit (day 7)
Breakup Time (BUT)
Time frame: will be evaluated at the end of the treatment at the final visit (day 7)
Number of Eyes With Epithelial Defects (ED) by Grade
Time frame: will be evaluated at the end of the treatment at the final visit (day 7)
Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade
Time frame: will be evaluated at the end of the treatment at the final visit (day 7)
Number of Eyes With Foreign Body Sensation (FBS) by Grade
Time frame: will be evaluated at the end of the treatment at the final visit (day 7)
Number of Eyes With Ocular Pruritus (P) by Grade
Time frame: will be evaluated at the end of the treatment at the final visit (day 7)
Number of Eyes of Chemosis
Time frame: will be evaluated at the end of the treatment at the final visit (day 7)
Visual Capacity
Time frame: will be evaluated at the end of the treatment at the final visit (day 7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 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-174 and Sophixín Ofteno® in people with Conjunctivitis and Conjunctivitis, Bacterial, 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 25 Oct 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 25 Oct 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?
Number of Adverse Events (EAS) (time frame: during the 12 days of evaluation, including the safety call (day 12).). 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 NCT03519516, 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 25 Oct 2019.