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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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

Other trials in Mexico

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 groups in NCT01657266
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.

Dec 2013Apr 2015

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)

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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus

All Cataract trials

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.

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

Results posted to the registry on 30 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PRO-155	73	69
Nevanac	75	70

Primary outcome: Percentage of Cellularity in Anterior Chamber

Time frame: day 30. Number. Unit: Percentage of Cellularity

Measure	PRO-155 n = 69	Nevanac n = 70
Day 1	64.2	64.3
Day 30	0	0

PRO-155: p = 1.00, Pearson´s Chi-square test

Population analysed: Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.

Primary outcome: Flare in Anterior Chamber

Time frame: day 30. Number. Unit: Percentage of Participants with flare

Measure	PRO-155 n = 69	Nevanac n = 70
Day 1	31.4	31.5
Day 30	0	0

Population analysed: Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PRO-155	0 of 73 (0%)	5 of 73 (6.8%)	Not reported
Nevanac	2 of 75 (2.7%)	2 of 75 (2.7%)	Not reported

Limitations and caveats (from the sponsor): The study was performed according to the clinical protocol.

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
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus

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?

On the ClinicalTrials.gov record for NCT01657266.

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.