CataractPhase 3PRO-145/IIINCT03693989
Clinical Study of the Efficacy of the Ophthalmic Emulsion PRO-145 for Inflammation and Pain After Phacoemulsification
A Phase 3 study testing Difluprednate 0.05% and Prednefrin in people with Cataract, run by Laboratorios Sophia S.A de C.V. at 5 sites in Mexico.
Trial summary
objective: To evaluate the efficacy of the ophthalmic emulsion PRO-145 in the treatment of inflammation and pain after phacoemulsification. Hypothesis: The use of the ophthalmic emulsion PRO-145 is effective in decreasing the inflammatory response evaluated by means of cellularity in the anterior chamber, after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Difluprednate 0.05% and Prednefrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 5 sitesMexico
- Study dates
- 4 Oct 2018to 22 Oct 2019
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Age ≥ 18 years.
- Both sexes.
- Postoperative cataract surgery by phacoemulsification. o That they have met the criteria for phacoemulsification and a classification of the lens opacity classification system (LOCS) III cataract of Opalescence of the nucleus (NO) ≥2 and Kernel color (NC) ≥2.
Who cannot join
- Pregnant women, lactating or planning to get pregnant.
- Women of reproductive age and who do not have a hormonal contraceptive method, intrauterine device or bilateral tubal obstruction.
- Participation in another clinical research study ≤ 30 days before the baseline visit.
- Have previously participated in this same study with the contralateral eye.
- That they can not comply with their attendance at appointments or with all the requirements of the protocol.
- Medical and therapeutic criteria.
Show all 32Show fewer
- Surgery in both eyes in the same surgical shift.
- Time> 24 hours after having surgery.
- Intraocular lens placement outside the bag.
- Presentation of rupture of the posterior capsule, with or without the presence of vitreous.
- Carrying out an iridectomy, or lesion of the pupillary sphincter during phacoemulsification surgery.
- Scheduled for surgical intervention in the contralateral eye during the study period.
- History of glaucoma or ocular hypertension.
- History of increased Intraocular pressure (IOP) with the use of steroids.
- Intraocular pressure (IOP) ≥24.
- History of uveitis.
- Presence of corneal abrasion or corneal ulceration in the study eye.
- Use of steroids or topical non steroidal anti inflammatory drugs, 24 hours prior to surgery and until the start of instillation of investigational drugs.
- Use of anticoagulants, systemic steroids or immunomodulators in the last two weeks
- Periocular injection of any steroid in the study eye 4 weeks before the start of the instillation of the investigational drugs.
- Use of storage steroids 2 months prior to the start of instillation of investigational drugs.
- Presence or suspicion of keratitis and / or viral, bacterial or fungal conjunctivitis.
- Presence or suspicion of endophthalmitis.
- Presence or suspicion of toxic syndrome of the anterior segment.
- Severe corneal edema that does not allow assessment of the anterior chamber
- Macular diseases.
- Diabetes Mellitus with glycosylated hemoglobin (A1C) ≥ 6.5% (48 mmol / mol) or fasting glucose (no caloric intake by ≥ 8 hours) of ≥ 126 mg / dL (7.0 mmol / L).
- Any disease or condition that requires the use of topical or systemic nonsteroidal anti-inflammatories (NSAIDs) during the time of intervention.
- Any disease or condition that requires the use of steroids other than topical ophthalmic application.
- Subjects with a single eye.
- Any condition or disease that at the discretion of the principal investigator (IP) does not make the subject suitable for the study.
- Known hypersensitivity to the components of the products under investigation.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Mexico5 sites
Catarata y Glaucoma de Occidente
Guadalajara, Jalisco, 44160
Novam y Vita
Guadalajara, Jalisco, 44620
Hospital de la luz
Mexico City, 06030
Fundación de asistencia privada Conde de Valenciana
Mexico City, 06800
Vision Cirugia Ambulatoria
Monterrey, Nuevo León, 64710
About this study
Official title: Clinical Study of the Efficacy of the Ophthalmic Emulsion PRO-145 for the Management of Inflammation and Pain After Phacoemulsification Compared to Prednisolone Acetate 1%.
objective: To evaluate the efficacy of the ophthalmic emulsion PRO-145 in the treatment of inflammation and pain after phacoemulsification.
Hypothesis:
Read more
The use of the ophthalmic emulsion PRO-145 is effective in decreasing the inflammatory response evaluated by means of cellularity in the anterior chamber, after phacoemulsification.
Methodology:
Phase III clinical trial, double-blind, controlled, parallel group, multicentre, randomized.
Number of patients:
178 subjects divided into 2 groups (89 subjects per group), who will provide an eye for the evaluation of efficacy.
Diagnosis and main inclusion criteria:
Diagnosis: Postoperative phacoemulsification and foldable intraocular lens placement in a bag.
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
- Cataract
- Being tested
- Difluprednate 0.05%, Prednefrin
- Keywords
- corticosteroid, anti-inflammatory steroid, phacoemulsification
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Difluprednate 0.05%Drug
Also called PRO-145
Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.
PrednefrinDrug
Also called Difluprednate
1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.
- Route of administration: topical ophthalmic
| Study group | Role | What they receive |
|---|---|---|
| PRO-145. | Experimental | Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. Receives: Drug: Difluprednate 0.05% |
| Prednefrin | Active comparator | Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V. Receives: Drug: Prednefrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Ability (VA)
The VA will be evaluated basally, without refractive correction with the Snellen chart. Which will be located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The result of the Snellen fraction will be transformed to its decimal equivalent in LogMAR, ex. 20/20= 1.0, 20/25=0.8, 20/40= 0.5, 20/200= 1.0, etc. The subjects will be averaged by group.
Measured: day 28 at the final visit
Adverse Events
The evaluation of adverse events requires a questioning conducted by the principal investigator and the appropriate exploratory techniques for its detection.
the number of cases with adverse events will be reported per study arm
Measured: day 28 at the final visit
Secondary outcomes (7)
Cellularity in the Anterior Chamber
unit: degrees, Direct observation (Biomicroscopy).
Scale for anterior chamber cellularity. Grade/Number of cells
Grade / Number of cells
0 Any
½ + 1-5
- + 6-15
- + 16-25
- + 26-60
- + More than 60 the cellularity will be measured according to the scale that is added next, considering as normal the degree 0, and abnormal any other degree.
Measured: day 28 at the final visit
Clinical Corneal Edema
The evaluation of clinical edema will be evaluated by the Efron scale, which is a series of factorial sections of the cornea, including features such as grooves and folds. The Efron scale has a strong correlation with variations in intensity. The number will be reported according to the rating awarded.
Efron Scale: 0 Normal, 1 very slight, 2 mild, 3 moderate and 4 severe.
Measured: day 28 at the final visit
Flare
In the presence of intraocular inflammation, the increased permeability of the non-pigmented layer of the ciliary epithelium, the posterior epithelium of the iris and the vascular endothelium of the iris results in the accumulation of cells and proteins (visible to the examiner as flare) in the anterior chamber. Using a light beam of 0.2mm X 0.2mm directed obliquely to the anterior chamber with a forward inclination of the light source (slit lamp tower) the degree of flare and cellularity will be determined according to the group of work of standardization for the nomenclature of uveitis.
Flare scale
0 There is no flare
- + Mild
- + Moderate (iris and crystalline clearly visible)
- + Marking (iris and crystalline slightly blurred)
- + More than 60 (fibrin)
Measured: day 28 at the final visit
Central Thickness of the Retina
By means of optical coherence tomography (OCT) the Retinal central thickness (GCR) will be measured. OCT is a noninvasive imaging test that uses light waves to take photographs of the cross section of the retina (the light-sensitive tissue that lines the back of the eye).With a OCT, each of the characteristic layers of the retina can be observed, allowing mapping and measuring its thickness a micrometer result will be obtained and the analysis will be carried out between groups.
Measured: day 28 at the final visit
Conjunctival Hyperemia
Conjunctival hyperemia is defined as the simplest reaction of the conjunctiva to a stimulus, a red appearance secondary to the vasodilation of the conjunctival vessels of variable intensity, we will use the Efron scale for conjunctival hyperemia.
0 normal
- very slight
- mild
- moderate
- severe
Measured: day 28 at the final visit
Intraocular Pressure
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: day 28 at the final visit
Symptomatology Post Instillation
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: day 28 at the final visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start4 Oct 2018
- Primary completion7 Aug 2019
- Study completion22 Oct 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 CataractStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind, controlled, parallel group, multicentre, randomized
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 178 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
- NCT03693989
- Sponsor's protocol ID
- SOPH145-0716 / III
- Acronym
- PRO-145/III
- Status last verified
- Nov 2019
- First submitted
- 1 Oct 2018
- Last updated
- 2 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Palacio-Pastrana C, Chavez-Mondragon E, Soto-Gomez A, Suarez-Velasco R, Montes-Salcedo M, Fernandez de Ortega L, Nasser-Nasser L, Baiza-Duran L, Olvera-Montano O, Munoz-Villegas P. Difluprednate 0.05% versus Prednisolone Acetate Post-Phacoemulsification for Inflammation and Pain: An Efficacy and Safety Clinical Trial. Clin Ophthalmol. 2020 Jun 12;14:1581-1589. doi: 10.2147/OPTH.S254705. eCollection 2020.
PubMed 32606573
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Efficacy of the Ophthalmic Emulsion PRO-145 for the Management of Inflammation and Pain After Phacoemulsification Compared to Prednisolone Acetate 1%.
- ClinicalTrials.gov ID
- NCT03693989
- Acronym / sponsor ID
- PRO-145/III / SOPH145-0716 / III
- Conditions
- Cataract
- Keywords
- corticosteroid, anti-inflammatory steroid, phacoemulsification
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 7 Aug 2019 (actual)
- Study completion
- 22 Oct 2019 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Posted 2 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
objective: To evaluate the efficacy of the ophthalmic emulsion PRO-145 in the treatment of inflammation and pain after phacoemulsification.
Hypothesis:
The use of the ophthalmic emulsion PRO-145 is effective in decreasing the inflammatory response evaluated by means of cellularity in the anterior chamber, after phacoemulsification.
Methodology:
Phase III clinical trial, double-blind, controlled, parallel group, multicentre, randomized.
Number of patients:
178 subjects divided into 2 groups (89 subjects per group), who will provide an eye for the evaluation of efficacy.
Diagnosis and main inclusion criteria:
Diagnosis: Postoperative phacoemulsification and foldable intraocular lens placement in a bag.
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
- double-blind, controlled, parallel group, multicentre, randomized
| Arm | Type | Receives |
|---|---|---|
| PRO-145. | Experimental | Drug: Difluprednate 0.05%Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. |
| Prednefrin | Active comparator | Drug: PrednefrinPrednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent.
- Age ≥ 18 years.
- Both sexes.
- Postoperative cataract surgery by phacoemulsification. o That they have met the criteria for phacoemulsification and a classification of the lens opacity classification system (LOCS) III cataract of Opalescence of the nucleus (NO) ≥2 and Kernel color (NC) ≥2.
Key exclusion criteria (32 listed)
- Pregnant women, lactating or planning to get pregnant.
- Women of reproductive age and who do not have a hormonal contraceptive method, intrauterine device or bilateral tubal obstruction.
- Participation in another clinical research study ≤ 30 days before the baseline visit.
- Have previously participated in this same study with the contralateral eye.
- That they can not comply with their attendance at appointments or with all the requirements of the protocol.
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 |
|---|---|---|
| Difluprednate 0.05%Also: PRO-145Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator. | Drug | PRO-145. |
| PrednefrinAlso: Difluprednate1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator. - Route of administration: topical ophthalmic | Drug | Prednefrin |
Primary outcome
Visual Ability (VA)
Time frame: day 28 at the final visit
The VA will be evaluated basally, without refractive correction with the Snellen chart. Which will be located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The result of the Snellen fraction will be transformed to its decimal equivalent in LogMAR, ex. 20/20= 1.0, 20/25=0.8, 20/40= 0.5, 20/200= 1.0, etc. The subjects will be averaged by group.
Adverse Events
Time frame: day 28 at the final visit
The evaluation of adverse events requires a questioning conducted by the principal investigator and the appropriate exploratory techniques for its detection. the number of cases with adverse events will be reported per study arm
7 secondary outcomes
Cellularity in the Anterior Chamber
Time frame: day 28 at the final visit
Clinical Corneal Edema
Time frame: day 28 at the final visit
Flare
Time frame: day 28 at the final visit
Central Thickness of the Retina
Time frame: day 28 at the final visit
Conjunctival Hyperemia
Time frame: day 28 at the final visit
Intraocular Pressure
Time frame: day 28 at the final visit
Symptomatology Post Instillation
Time frame: day 28 at the final visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32606573Palacio-Pastrana C, Chavez-Mondragon E, Soto-Gomez A, Suarez-Velasco R, Montes-Salcedo M, Fernandez de Ortega L, Nasser-Nasser L, Baiza-Duran L, Olvera-Montano O, Munoz-Villegas P. Difluprednate 0.05% versus Prednisolone Acetate Post-Phacoemulsification for Inflammation and Pain: An Efficacy and Safety Clinical Trial. Clin Ophthalmol. 2020 Jun 12;14:1581-1589. doi: 10.2147/OPTH.S254705. eCollection 2020.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Difluprednate 0.05% and Prednefrin in people with Cataract, run by Laboratorios Sophia S.A de C.V. at 5 sites 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 4 inclusion and 32 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 2 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 5 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 2 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?
Visual Ability (VA) (time frame: day 28 at the final visit). 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 NCT03693989, 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 2 Dec 2019.