CataractPhase 2NCT01657266
Efficacy and Safety of PRO-155 Versus Nevanac in Post Phacoemulsification
A Phase 2 study testing PRO-155 and Nevanac in people with Cataract and Phacoemulsification Cataract Surgery, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial summary
The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-155 in patients post phacoemulsification. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Phacoemulsification Cataract Surgery
- What is being tested?
- PRO-155 and Nevanac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteMexico
- Study dates
- Dec 2013to Apr 2015
- Phase
- Phase 2
- 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
- Patients older than 18 years who require cataract surgery
- Both genders
- Provide informed consent
- Normal Laboratory results
Who cannot join
- Patients with visual acuity of 20/40 or less in the contralateral eye of the surgery
- Patients with any trans-surgical complication
- Patients with a cataract >NC4, C4 or P4 classified with the system LOCS
- Patients with any active corneal pathology
- Patients under any steroidal treatment (topic, systemic or inhaled)14 days prior surgery or NSAIDs 7 days before the surgery (except low-dose aspirin)
- Patients with IOP <5 or >21 mmHg
Show all 19Show fewer
- Patients that have ocular pain, cellularity or flare at the moment of selection
- Patients with ocular exfoliation, trauma or any inflammatory disease
- Patients with diabetic retinopathy that need treatment or uncontrolled diabetes mellitus
- Patients who are planning cataract surgery of the contralateral eye 14 days after surgery of the study eye
- Patients with history of hypersensitivity or contraindication for any drug used in the study
- Patients under anticoagulant treatment
- Contact lens users
- Pregnant patients, at risk of pregnancy or breastfeeding
- Patients without birth control treatment
- Patients with any active toxicomania (alcoholism, cigarette, cannabis or others)
- Patients who had participated in any clinical trial in the last 90 days
- Legal or mentally disabled patients who could not give informed consent
- Patients who cannot comply with all study requirements
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
About this study
Official title: Phase 2 Randomized, Double-blind Clinical Trial to Evaluate Efficacy and Safety of the Ophthalmic Solution PRO-155 Versus Nevanac 0.1% Ophthalmic Solution in Post Phacoemulsification Patients
The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-155 in patients post phacoemulsification.
Read the detailed description
Postsurgical inflammation is an inevitable condition after cataract surgery. The use of non-steroidal anti-inflammatory drugs is a safe option for treating ocular inflammation.
This is a phase II randomized double-blind clinical trial. The aim is to compare and to evaluate efficacy and safety of two ophthalmic solutions in patients post phacoemulsification. Patients will be randomized to receive either PRO-155 or Nevanac for 60 days.
- Conditions
- Cataract, Phacoemulsification Cataract Surgery
- Being tested
- PRO-155, Nevanac
- Keywords
- bromfenac, nepafenac, cataract, phacoemulsification cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-155Drug
Pre-medication (before surgery) and maintenance treatment.
NevanacDrug
Pre-medication (before surgery) and maintenance treatment.
| Study group | Role | What they receive |
|---|---|---|
| PRO-155 | Experimental | Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days Receives: Drug: PRO-155 |
| Nevanac | Active comparator | Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days Receives: Drug: Nevanac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Cellularity in Anterior Chamber
Change from Percentage of Cellularity in anterior chamber after 30 days of treatment.
Measured: day 30
Flare in Anterior Chamber
Percentage of Participants with flare in anterior chamber after 30 days of treatment
Measured: day 30
Secondary outcomes (2)
Percentage of Patients Without Ocular Pain
percentage of patients without pain, would be measured using the Visual Analog Pain Scale
Measured: day 30
Mean Aqueous Concentration of Intervention Drug
a nurse was instructed to instill five drops of the research product into each patient's eye in the hour before surgery. The concentration of the drug was determined for aqueous humor sample (0.15 mL) with a 30-gauge needle on a TB syringe after completion of the paracentesis. The paracentesis was performed after first incision during the phacoemulsification.
Measured: before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startDec 2013
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 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 M. Baiza-Durán, MD, Study director, Laboratorios Sophia S.A de C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657266
- Sponsor's protocol ID
- SOPH155-0412/II
- Status last verified
- Feb 2018
- First submitted
- 19 Jul 2012
- Last updated
- 30 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: The personal data were collected and analyzed according to confidentiality policy.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized, Double-blind Clinical Trial to Evaluate Efficacy and Safety of the Ophthalmic Solution PRO-155 Versus Nevanac 0.1% Ophthalmic Solution in Post Phacoemulsification Patients
- ClinicalTrials.gov ID
- NCT01657266
- Acronym / sponsor ID
- SOPH155-0412/II
- Conditions
- Cataract, Phacoemulsification Cataract Surgery
- Keywords
- bromfenac, nepafenac, cataract, phacoemulsification cataract surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 Aug 2012 (estimated)
- Results
- Posted 30 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-155 in patients post phacoemulsification.
Detailed description
Postsurgical inflammation is an inevitable condition after cataract surgery. The use of non-steroidal anti-inflammatory drugs is a safe option for treating ocular inflammation.
This is a phase II randomized double-blind clinical trial. The aim is to compare and to evaluate efficacy and safety of two ophthalmic solutions in patients post phacoemulsification. Patients will be randomized to receive either PRO-155 or Nevanac for 60 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRO-155 | Experimental | Drug: PRO-155Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye Maintenance therapy: 1 drop 3 times a day for 30 days |
| Nevanac | Active comparator | Drug: NevanacNepafenac 0.1% (1mg/mL) Ophthalmic Suspension Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye Maintenance therapy: 1 drop 3 times a day for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 18 years who require cataract surgery
- Both genders
- Provide informed consent
- Normal Laboratory results
Key exclusion criteria (19 listed)
- Patients with visual acuity of 20/40 or less in the contralateral eye of the surgery
- Patients with any trans-surgical complication
- Patients with a cataract >NC4, C4 or P4 classified with the system LOCS
- Patients with any active corneal pathology
- Patients under any steroidal treatment (topic, systemic or inhaled)14 days prior surgery or NSAIDs 7 days before the surgery (except low-dose aspirin)
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-155Pre-medication (before surgery) and maintenance treatment. | Drug | PRO-155 |
| NevanacPre-medication (before surgery) and maintenance treatment. | Drug | Nevanac |
Primary outcome
Percentage of Cellularity in Anterior Chamber
Time frame: day 30
Change from Percentage of Cellularity in anterior chamber after 30 days of treatment.
Flare in Anterior Chamber
Time frame: day 30
Percentage of Participants with flare in anterior chamber after 30 days of treatment
2 secondary outcomes
Percentage of Patients Without Ocular Pain
Time frame: day 30
Mean Aqueous Concentration of Intervention Drug
Time frame: before surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Palacio C, et al. Bromfenac 0.09% bioavailability in aqueous humor, prophylactic effect on cystoid macular edema, and clinical signs of ocular inflammation after phacoemulsification in a Mexican population. Clinical Ophthalmology 2016;10:233-237Link provided by the sponsor.
- Individual participant dataSharing planned: No. The personal data were collected and analyzed according to confidentiality policy.
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Not yet recruiting
Safety and Clinical Performance of the LENTIS® MAX LS-313 MF80 Compared With the Monofocal L-313 in Cataract Patients With Late Age-Related Macular Degeneration: A Multicenter Comparative Clinical Investigation.
Cataract, AMD - Age-Related Macular Degeneration
RecruitingObservational study
Capella Scientia Development Study
Cataract
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 M. 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 2 study testing PRO-155 and Nevanac in people with Cataract and Phacoemulsification Cataract Surgery, 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 4 inclusion and 19 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 30 Oct 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 30 Oct 2018). 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?
Percentage of Cellularity in Anterior Chamber (time frame: day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.