MyopiaNCT01475877
Bromday Versus Nevanac Eye Drops to Control Pain Following Photorefractive Keratectomy
An observational study of Myopia, run by Virdi Eye Clinic at 1 site in United States.
Trial summary
This study will compare the effect of two topical non-steroidal antiinflammatory agents to control pain after photorefractive keratectomy (PRK) eye surgery. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Bromfenac
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to May 2012
- Phase
- Observational
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients undergoing photorefractive keratectomy in both eyes
Who may be able to join
- male or female at least 18 years of age,
- no other ocular studies with 15 days prior to dosing,
- BCVA 20/200 or better,
- return for study visits and follow instructions from investigator and staff,
- self administer test article
Who cannot join
- Ocular inflammation,
- hypersensitivity to bromfenac or nepafenac,
- any corneal pathology,
- have had radial keratotomy,
- corneal transplant or corneal refractive surgery in the last two years
Trial locations and contacts
1 site in 1 country.
United States1 site
Virdi Eye Clinic and Laser Vision Center
Rock Island, Illinois, 61201
About this study
Official title: Bromday (Bromfenac Ophthalmic Solution)0.09% QD vs Nevanac (Nepafenac Ophthalmic Suspension) 0.1% TID for Control of Pain and Epithelial Healing Post (PRK)
This study will compare the effect of two topical non-steroidal antiinflammatory agents to control pain after photorefractive keratectomy (PRK) eye surgery.
- Conditions
- Myopia
- Being tested
- Bromfenac
- Keywords
- bromfenac, nepafenac, PRK, epithelial healing,
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BromfenacDrug
Also called Bromday
Bromfenac 0.09% 1 drop in study eyes q day
| Study group | Role | What they receive |
|---|---|---|
| Nepafenac | Not described Receives: Drug: Bromfenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-PRK pain
Measured: 7 days
Secondary outcomes (1)
Post-PRK epithelial healing
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virdi Eye Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Navaneet S Borisuth, MD,PhD, Principal investigator, Virdi Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475877
- Sponsor's protocol ID
- MAC-02-11
- Status last verified
- May 2016
- First submitted
- 7 Nov 2011
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: In the observational study conducted, there was no significant difference in pain levels or epithelial healing of post-photorefractive keratectomy patients who were treated with bromfenac 0.09% or nepafenac 0.1%
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bromday (Bromfenac Ophthalmic Solution)0.09% QD vs Nevanac (Nepafenac Ophthalmic Suspension) 0.1% TID for Control of Pain and Epithelial Healing Post (PRK)
- ClinicalTrials.gov ID
- NCT01475877
- Acronym / sponsor ID
- MAC-02-11
- Conditions
- Myopia
- Keywords
- bromfenac, nepafenac, PRK, epithelial healing,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Virdi Eye ClinicUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 21 Nov 2011 (estimated)
- 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.
This study will compare the effect of two topical non-steroidal antiinflammatory agents to control pain after photorefractive keratectomy (PRK) eye surgery.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nepafenac | – | Drug: Bromfenac |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing photorefractive keratectomy in both eyes
Key inclusion criteria (5 listed)
- male or female at least 18 years of age,
- no other ocular studies with 15 days prior to dosing,
- BCVA 20/200 or better,
- return for study visits and follow instructions from investigator and staff,
- self administer test article
Key exclusion criteria (5 listed)
- Ocular inflammation,
- hypersensitivity to bromfenac or nepafenac,
- any corneal pathology,
- have had radial keratotomy,
- corneal transplant or corneal refractive surgery in the last two years
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: BromdayBromfenac 0.09% 1 drop in study eyes q day | Drug | Nepafenac |
Primary outcome
Post-PRK pain
Time frame: 7 days
1 secondary outcome
Post-PRK epithelial healing
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
- Individual participant dataSharing planned: No. In the observational study conducted, there was no significant difference in pain levels or epithelial healing of post-photorefractive keratectomy patients who were treated with bromfenac 0.09% or nepafenac 0.1%
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Recruiting
Mobility Performance in Daily Activities Among Children Wearing Spectacle Lenses
Myopia, Myopia Progression
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.
Navaneet S Borisuth, MD,PhD principal investigator
Virdi Eye Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Virdi Eye Clinic at 1 site in United States.
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 5 inclusion and 5 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 3 May 2016. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post-PRK pain (time frame: 7 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 3 May 2016.