CataractPhase 4NCT03831984
Topical Bromfenac for Intraoperative Miosis and Pain Reduction
A Phase 4 study testing 0,09% Bromfenac and 0,1% sodium hyaluronate in people with Cataract, run by Hospital de La Luz at 1 site in Mexico.
Trial summary
To evaluate the effect of bromfenac ophthalmic solution 0.09% for reduction of intraoperative miosis and pain in patient who have undergone femtosecond laser-assisted cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- 0,09% Bromfenac and 0,1% sodium hyaluronate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2018to 30 Mar 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Male and female
- Subjects 18 years or older
- Patients scheduled for unilateral femtosecond laser-assisted cataract surgery cataract surgery with posterior chamber (PC) IOL implantation.
Who cannot join
- Presence of corneal abnormalities
- History of intraocular surgery
- History of ocular or systematic diseases (glaucoma, diabetes, uveitis
- Regular, systemic use of steroid or NSAIDs during the previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical 0,09% Bromfenac for Intraoperative Miosis and Pain Reduction in Femtosecond Laser-assisted Cataract Surgery
To evaluate the effect of bromfenac ophthalmic solution 0.09% for reduction of intraoperative miosis and pain in patient who have undergone femtosecond laser-assisted cataract surgery.
Read the detailed description
This prospective cross-sectional randomized clinical study included 60 patients with senile cataract in the absence of significant ocular comorbidity. The patients received 0.09% bromfenac ophthalmic solution or control placebo twice a day for 3 days before surgery. Pupil diameter was measured at the initiation and finalization of femtosecond laser-assisted cataract surgery and pain quantification was assessed by analogous pain scale at one day follow-up.
- Conditions
- Cataract
- Being tested
- 0,09% Bromfenac, 0,1% sodium hyaluronate
- Keywords
- Phacoemulsification, femtosecond laser, bromfenac, NSAID, pupil
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0,09% BromfenacDrug
Also called Zebesten
topical 0,09% Bromfenac, one drop twice daily 3 days before surgery
0,1% sodium hyaluronateDrug
Also called Hyabak
topical 0,1% sodium hyaluronate, one drop twice daily 3 days before surgery
| Study group | Role | What they receive |
|---|---|---|
| 0,09% Bromfenac | Active comparator | Topical 0,09% Bromfenac twice daily 3 days before surgery Receives: Drug: 0,09% Bromfenac |
| 0,1% sodium hyaluronate | Placebo comparator | Topical 0,1% sodium hyaluronate twice daily 3 days before surgery Receives: Drug: 0,1% sodium hyaluronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative miosis
Evaluation of reduction of intraoperative miosis before and after femtosecond laser assisted cataract surgery
Measured: 2 days
Secondary outcomes (1)
postoperative pain
Evaluation of reduction of postoperative pain using a visual analogue scale
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 Mar 2018
- Primary completion30 Nov 2018
- Study completion30 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de La Luz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Camila Aguilar Sierra, Hospital de La Luz
- Investigators
- MARIA AGUILAR SIERRA, MD, Principal investigator, FELLOWSHIP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831984
- Sponsor's protocol ID
- MAguilarSierra
- Status last verified
- Feb 2019
- First submitted
- 4 Feb 2019
- Last updated
- 6 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical 0,09% Bromfenac for Intraoperative Miosis and Pain Reduction in Femtosecond Laser-assisted Cataract Surgery
- ClinicalTrials.gov ID
- NCT03831984
- Acronym / sponsor ID
- MAguilarSierra
- Conditions
- Cataract
- Keywords
- Phacoemulsification, femtosecond laser, bromfenac, NSAID, pupil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital de La LuzUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Mar 2019 (estimated)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect of bromfenac ophthalmic solution 0.09% for reduction of intraoperative miosis and pain in patient who have undergone femtosecond laser-assisted cataract surgery.
Detailed description
This prospective cross-sectional randomized clinical study included 60 patients with senile cataract in the absence of significant ocular comorbidity. The patients received 0.09% bromfenac ophthalmic solution or control placebo twice a day for 3 days before surgery. Pupil diameter was measured at the initiation and finalization of femtosecond laser-assisted cataract surgery and pain quantification was assessed by analogous pain scale at one day follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0,09% Bromfenac | Active comparator | Drug: 0,09% BromfenacTopical 0,09% Bromfenac twice daily 3 days before surgery |
| 0,1% sodium hyaluronate | Placebo comparator | Drug: 0,1% sodium hyaluronateTopical 0,1% sodium hyaluronate twice daily 3 days before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female
- Subjects 18 years or older
- Patients scheduled for unilateral femtosecond laser-assisted cataract surgery cataract surgery with posterior chamber (PC) IOL implantation.
Key exclusion criteria (4 listed)
- Presence of corneal abnormalities
- History of intraocular surgery
- History of ocular or systematic diseases (glaucoma, diabetes, uveitis
- Regular, systemic use of steroid or NSAIDs during the previous 3 months
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 |
|---|---|---|
| 0,09% BromfenacAlso: Zebestentopical 0,09% Bromfenac, one drop twice daily 3 days before surgery | Drug | 0,09% Bromfenac |
| 0,1% sodium hyaluronateAlso: Hyabaktopical 0,1% sodium hyaluronate, one drop twice daily 3 days before surgery | Drug | 0,1% sodium hyaluronate |
Primary outcome
intraoperative miosis
Time frame: 2 days
Evaluation of reduction of intraoperative miosis before and after femtosecond laser assisted cataract surgery
1 secondary outcome
postoperative pain
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- 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.
MARIA AGUILAR SIERRA, MD principal investigator
FELLOWSHIP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0,09% Bromfenac and 0,1% sodium hyaluronate in people with Cataract, run by Hospital de La Luz 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Feb 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
intraoperative miosis (time frame: 2 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 6 Feb 2019.