GlaucomaPhase 1PRO-122/INCT03966365
Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®
A Phase 1 study testing PRO-122 and Krytantek Ofteno® in people with Glaucoma, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial summary
Therapeutic indication: Ocular hypotensive Use: Primary open-angle glaucoma and ocular hypertension. Objectives: To evaluate the safety and tolerability of the preservative-free formulation PRO-122 manufactured by Sophia Laboratories, S.A. of C.V. on the ocular surface of 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
- Glaucoma
- What is being tested?
- PRO-122 and Krytantek Ofteno®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteMexico
- Study dates
- 2 May 2019to 30 Aug 2019
- 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
- Ability to give your signed informed consent, and show willingness to comply with study procedures and to modify your lifestyle activities (Section 6.2.2)
- Age between 18 to 45 years.
- Indistinct sex.
- Women must ensure a hormonal contraceptive method or intrauterine device during the study period.
- Blood tests: within normal parameters or with a range of ± 20% as long as the subject is clinically healthy.
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- Blood count (BH): Hemoglobin, erythrocytes, hematocrit, total leukocytes, platelets, mean corpuscular volume and mean corpuscular hemoglobin.
- Blood chemistry of three elements (QS): Glucose, urea and creatinine.
- Liver function tests (PFH): Aspartate Aminotransferase and Alanine Aminotransferase, total bilirubin, direct and indirect.
- Visual ability 20/30 or better in both eyes.
- Vital signs within normal parameters.
- Intraocular pressure ≥10 and ≤ 21 mmHg.
Who cannot join
- Users of topical ophthalmic products of any kind.
- Users of medicines, or herbal products, by any other route of administration, with the exception of hormonal contraceptives in the case of women.
- Women who are pregnant or breastfeeding.
- Participation in clinical research studies 90 days prior to inclusion in the present study.
- Previous participation in this same study.
- Users of contact lenses.
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- 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 admission to the study.
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
About this study
Official title: Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®, Elaborated by Sophia Laboratories, S.A. of C.V. on the Ocular Surface of Ophthalmologically and Clinically Healthy Subjects
Therapeutic indication: Ocular hypotensive Use: Primary open-angle glaucoma and ocular hypertension.
Objectives: To evaluate the safety and tolerability of the preservative-free formulation PRO-122 manufactured by Sophia Laboratories, S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis: The ophthalmic solution PRO-122 presents a profile of safety and tolerability similar to Krytantek Ofteno®, in healthy subjects.
Methodology: Phase I clinical trial, controlled, parallel group, double blind, randomized.
Number of patients: n=24 12 subjects per group (both eyes). Main inclusion criteria:Clinically healthy subjects.
Read the detailed description
Number of patients: n = 24 12 subjects per group (both eyes). Main inclusion criteria: Clinically healthy subjects.
Treatment duration: 7 days. Duration of subject in the study: 15 to 22 days.
Adverse events will be reported and cataloged based on the MedDRA dictionary and will be reported to the corresponding regulatory entity.
The sponsor will carry out monitoring or quality visits to the research sites where it corroborates the information of the source documents and will contrast them with the information presented in the electronic CRF. Electronic case report forms will be evaluated by the clinical research associate and the clinical team of the sponsor (medical ophthalmologist researcher and pharmacologist of clinical safety).
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 by means of the Mann-Whitney U test for the quantitative variables for the difference between the groups. The difference between the qualitative variables will be analyzed by means of X2 (Chi2). An alpha ≤ 0.05 will be considered significant.
- Conditions
- Glaucoma
- Being tested
- PRO-122, Krytantek Ofteno®
- Keywords
- Glaucoma, Krytantek, Krytantek PF, PRO-122
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-122Drug
Also called timolol 0.5%, brimonidine 0.2%, dorzolamide 2%, Krytantek PF
- PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
- Route of administration: topical ophthalmic.
Krytantek Ofteno®Drug
Also called timolol 0.5%, brimonidine 0.2%, dorzolamide 2%
- - 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
- - Route of administration: topical ophthalmic.
| Study group | Role | What they receive |
|---|---|---|
| PRO-122 | Experimental | - Dosage: 1 drop every 12 hours, in both eyes Receives: Drug: PRO-122 |
| Krytantek Ofteno® | Active comparator | - Dosage: 1 drop every 12 hours, in both eyes Receives: Drug: Krytantek Ofteno® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
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. it will be evaluated by the number of reported cases per group.
Measured: during the 14 days of evaluation, including the safety call (day 14)
Eye 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).The Eye comfort index contains items that focus on the discomfort associated with alterations of the ocular surface.
Values closer or equal to one hundred (100) correspond to greater discomfort, while values closer or equal to zero (0) correspond to greater comfort.
Measured: will be evaluated at the end of the treatment, at the final visit (day 8)
Secondary outcomes (4)
Number of Eyes With Epithelial Defects by Grade
The epithelial defects will be evaluated by means of two stains, green lissamine 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 8)
Visual Ability
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 or 1.0 in decimal and the worst 20/200 or 0.1 in decimal number.
For the appropriate management of the data, the result of the fraction obtained from the snellen scale is transformed to decimals, in this case subjects close to or equal to 1.0 have better visual acuity while subjects close to or equal to 0.1 have worse visual acuity.
The decimal equivalence scale is the result of the division of the fraction obtained in the Snellen chart. where 20/20 = 1.0; Do not confuse with Logmar scale where 20/20 = 0.0
Equivalences Snellen Scale = decimals: 20/200=0.1, 20/100=0.2, 20/50=0.4, 20/40=0.5, 20/30=0.66, 20/25=0.8, 20/20=1.0, etc.
Measured: will be evaluated at the end of the treatment, at the final visit (day 8)
Participants 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 8)
Participants With 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 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start2 May 2019
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
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 GlaucomaStudies 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, parallel group, double blind, randomized.
- Masking
- Double blind
- Who is masked
- 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
- NCT03966365
- Sponsor's protocol ID
- SOPH122-0518/I
- Acronym
- PRO-122/I
- Status last verified
- Dec 2019
- First submitted
- 24 May 2019
- Last updated
- 13 Dec 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 13 Dec 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 Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®, Elaborated by Sophia Laboratories, S.A. of C.V. on the Ocular Surface of Ophthalmologically and Clinically Healthy Subjects
- ClinicalTrials.gov ID
- NCT03966365
- Acronym / sponsor ID
- PRO-122/I / SOPH122-0518/I
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Krytantek, Krytantek PF, PRO-122
- 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
- 2 May 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Posted 13 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Therapeutic indication: Ocular hypotensive Use: Primary open-angle glaucoma and ocular hypertension.
Objectives: To evaluate the safety and tolerability of the preservative-free formulation PRO-122 manufactured by Sophia Laboratories, S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis: The ophthalmic solution PRO-122 presents a profile of safety and tolerability similar to Krytantek Ofteno®, in healthy subjects.
Methodology: Phase I clinical trial, controlled, parallel group, double blind, randomized.
Number of patients: n=24 12 subjects per group (both eyes). Main inclusion criteria:Clinically healthy subjects.
Detailed description
Number of patients: n = 24 12 subjects per group (both eyes). Main inclusion criteria: Clinically healthy subjects.
Treatment duration: 7 days. Duration of subject in the study: 15 to 22 days.
Adverse events will be reported and cataloged based on the MedDRA dictionary and will be reported to the corresponding regulatory entity.
The sponsor will carry out monitoring or quality visits to the research sites where it corroborates the information of the source documents and will contrast them with the information presented in the electronic CRF. Electronic case report forms will be evaluated by the clinical research associate and the clinical team of the sponsor (medical ophthalmologist researcher and pharmacologist of clinical safety).
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 by means of the Mann-Whitney U test for the quantitative variables for the difference between the groups. 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
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase I clinical trial, controlled, parallel group, double blind, randomized.
| Arm | Type | Receives |
|---|---|---|
| PRO-122 | Experimental | Drug: PRO-122- Dosage: 1 drop every 12 hours, in both eyes |
| Krytantek Ofteno® | Active comparator | Drug: Krytantek Ofteno®- Dosage: 1 drop every 12 hours, in both eyes |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- - Clinically healthy
- Ability to give your signed informed consent, and show willingness to comply with study procedures and to modify your lifestyle activities (Section 6.2.2)
- Age between 18 to 45 years.
- Indistinct sex.
- Women must ensure a hormonal contraceptive method or intrauterine device during the study period.
Key exclusion criteria (9 listed)
- Users of topical ophthalmic products of any kind.
- Users of medicines, or herbal products, by any other route of administration, with the exception of hormonal contraceptives in the case of women.
- Women who are pregnant or breastfeeding.
- Participation in clinical research studies 90 days prior to inclusion in the present study.
- Previous participation in this same 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-122Also: timolol 0.5%, brimonidine 0.2%, dorzolamide 2%, Krytantek PF* PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. * Route of administration: topical ophthalmic. | Drug | PRO-122 |
| Krytantek Ofteno®Also: timolol 0.5%, brimonidine 0.2%, dorzolamide 2%* - 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. * - Route of administration: topical ophthalmic. | Drug | Krytantek Ofteno® |
Primary outcome
Number of Adverse Events
Time frame: during the 14 days of evaluation, including the safety call (day 14)
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. it will be evaluated by the number of reported cases per group.
Eye Comfort Index
Time frame: will be evaluated at the end of the treatment, at the final visit (day 8)
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).The Eye comfort index contains items that focus on the discomfort associated with alterations of the ocular surface. Values closer or equal to one hundred (100) correspond to greater discomfort, while values closer or equal to zero (0) correspond to greater comfort.
4 secondary outcomes
Number of Eyes With Epithelial Defects by Grade
Time frame: will be evaluated at the end of the treatment, at the final visit (day 8)
Visual Ability
Time frame: will be evaluated at the end of the treatment, at the final visit (day 8)
Participants With Conjunctival Hyperemia (CH) by Grade
Time frame: will be evaluated at the end of the treatment, at the final visit (day 8)
Participants With Chemosis
Time frame: will be evaluated at the end of the treatment, at the final visit (day 8)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 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-122 and Krytantek Ofteno® in people with Glaucoma, 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 12 inclusion and 9 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 13 Dec 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 13 Dec 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 (time frame: during the 14 days of evaluation, including the safety call (day 14)). 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 NCT03966365, 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 13 Dec 2019.