InflammationPhase 1PRO-155NCT01535443
Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.
A Phase 1 study testing Bromfenac in people with Inflammation and Cataract, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial summary
Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Cataract
- What is being tested?
- Bromfenac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2011to Oct 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female.
- Age ≥ 18 years old at screening visit
Who cannot join
- Any ocular or systemic condition.
- Patient with one blind eye.
- Visual acuity of 20/40 in any eye.
- Use of ocular or systemic medications.
- Contraindications or sensitivity to any component of the study treatments.
- Contact lens users.
Show all 9Show fewer
- Ocular surgery within the past 3 months..
- Women who were not using an effective means of contraception or who were pregnant or nursing.
- Participation in any studies of investigational drugs within 90 days previous to the inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fase 1 Study to Evaluate the Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.
Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.
Read the detailed description
A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.
- Conditions
- Inflammation, Cataract
- Being tested
- Bromfenac
- Keywords
- PRO-155, Ocular NSAIDs, Safety and tolerability, Ocular Inflammation, Ocular Paint
- Medical subject headings
- Inflammation, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BromfenacDrug
Also called PROJECT SOPHIA PRO-155
Drug: Bromfenac Other names: PRO-155
| Study group | Role | What they receive |
|---|---|---|
| Bromfenac | Experimental | Drug: Bromfenac ophthalmic solution 1 drop 4 times per day Receives: Drug: Bromfenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
A Snellen chart is an eye chart that can be used to measure visual acuity. consisting of a scale ranging from 20 to 200, where 20 is the best visual capacity and 200 is the worst
Measured: 10 days
Secondary outcomes (11)
Adverse Events
will be reported the presence of adverse events presented in the study group during the intervention period .
Measured: 10 days
Findings in Posterior Segment
Abnormal bores will be reported when assessing the integrity of the posterior segment, the unit of measure will be number of findings.
Measured: 10 days
Intraocular Pressure (IOP)
Intraocular pressure (IOP) measurement by applanation tonometry. The unit of measurement will be millimeters of mercury (mmhg) the normal range will be considered 11 to 21 mmhg.
Measured: 10 days
Hyperemia
The red eye will be evaluated by the absence or presence of hyperemia.
Measured: 10 days
Burning
Eye ocular burning will be reported according to the following scale: absent, mild, moderate and severe.
Measured: 10 days
Tearing
Tearing will be reported according to the following scale: absent, mild, moderate and severe.
Measured: 10 days
Foreign Body Sensation
Foreign body sensation will be reported according to the following scale: absent, mild, moderate and severe.
Measured: 10 days
Photophobia
photophobia will be reported according to the following scale: absent, mild, moderate and severe.
Measured: 10 days
Chemosis
chemosis will be reported according to the following scale: absent, mild, moderate and severe.
Measured: 10 days
Corneal Damage by Fluorescein Staining Test
Corneal damage will be reported by Fluorescein eye staining using the following scale: absent, mild, moderate, and severe.
Measured: 10 days
Corneal Damage by Lissamine Green Staining Test
Corneal damage will be reported by lissamine green staining using the following scale: absent, mild, moderate, and severe.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionOct 2011
- Study completionOct 2011
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 InflammationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alfredo Lizarraga-Corona, MD, Principal investigator, Unidad Medica "Grupo Pediátrico"Leopoldo M Baiza-Duran, MD, Study director, Clinical Research Department. Laboratorios Sophia SA de CV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535443
- Sponsor's protocol ID
- BRON0611V1FI
- Acronym
- PRO-155
- Status last verified
- Oct 2019
- First submitted
- 14 Feb 2012
- Last updated
- 16 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fase 1 Study to Evaluate the Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT01535443
- Acronym / sponsor ID
- PRO-155 / BRON0611V1FI
- Conditions
- Inflammation, Cataract
- Keywords
- PRO-155, Ocular NSAIDs, Safety and tolerability, Ocular Inflammation, Ocular Paint
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 17 Feb 2012 (estimated)
- Results
- Posted 19 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.
Detailed description
A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bromfenac | Experimental | Drug: BromfenacDrug: Bromfenac ophthalmic solution 1 drop 4 times per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male and female.
- Age ≥ 18 years old at screening visit
Key exclusion criteria (9 listed)
- Any ocular or systemic condition.
- Patient with one blind eye.
- Visual acuity of 20/40 in any eye.
- Use of ocular or systemic medications.
- Contraindications or sensitivity to any component of the study treatments.
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 |
|---|---|---|
| BromfenacAlso: PROJECT SOPHIA PRO-155Drug: Bromfenac Other names: PRO-155 | Drug | Bromfenac |
Primary outcome
Visual Acuity
Time frame: 10 days
A Snellen chart is an eye chart that can be used to measure visual acuity. consisting of a scale ranging from 20 to 200, where 20 is the best visual capacity and 200 is the worst
11 secondary outcomes
Adverse Events
Time frame: 10 days
Findings in Posterior Segment
Time frame: 10 days
Intraocular Pressure (IOP)
Time frame: 10 days
Hyperemia
Time frame: 10 days
Burning
Time frame: 10 days
Tearing
Time frame: 10 days
Foreign Body Sensation
Time frame: 10 days
Photophobia
Time frame: 10 days
Chemosis
Time frame: 10 days
Corneal Damage by Fluorescein Staining Test
Time frame: 10 days
Corneal Damage by Lissamine Green Staining Test
Time frame: 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Alfredo Lizarraga-Corona, MD principal investigator
Unidad Medica "Grupo Pediátrico"
Leopoldo M Baiza-Duran, MD study director
Clinical Research Department. Laboratorios Sophia SA de CV
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 Bromfenac in people with Inflammation and Cataract, 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 2 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 16 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 19 Jul 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 Acuity (time frame: 10 days). 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 16 Oct 2019.