MyopiaPhase 4NCT00347204
Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK
A Phase 4 study testing ketorolac (Acular LS) and Nepafenac (Nevanac) in people with Myopia and Hyperopia, run by Center For Excellence In Eye Care.
Trial summary
To determine the ability of two topical Nonsteroidal Anti-inflammatory drops (Acular LS \& Nevanac) to help control pain following Photorefractive Keratectomy (PRK). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- What is being tested?
- ketorolac (Acular LS) and Nepafenac (Nevanac)
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jun 2006
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing PRK for myopia or hyperopia
Who cannot join
- -
About this study
Official title: Double Masked Evaluation of Acular LS Versus Nevanac for Postoperative Pain Control in Eyes Undergoing PRK
To determine the ability of two topical Nonsteroidal Anti-inflammatory drops (Acular LS \& Nevanac) to help control pain following Photorefractive Keratectomy (PRK).
Read the detailed description
Laser Vision Correction is the most commonly performed elective surgical procedure in the United States. Although Laser-Assisted in-situ Keratomileusis (LASIK) is the more popular technique, a growing number of surgeons have switched to surface ablation techniques, including PRK, LASEK and Epi-LASIK.1 With surface laser procedures, the corneal epithelium is removed by a variety of techniques (laser, manual debridement, diluted alcohol2,3, epi-keatome) prior to laser reshaping of the corneal stroma. Following the procedure, a contact lens is placed on the eye to promote epithelial regeneration. Due to the size of the epithelial defect, it can take between 3 to 6 days for the epithelium to regenerate. During this healing process, patients often complain of moderate to severe ocular pain, and delayed healing may result in an increased risk of infection or corneal haze4.
Over the past decade, a variety of methods have been used to assist with reducing pain following surface laser procedures. Topical Nonsteroidals have been shown in a number of studies to help reduce the degree of pain following PRK. Topical dilute tetracaine has also been shown to assist with the reduction of pain following PRK. Oral pain medications, such as Vioxx, Celebrex, and even Prednisone have been recommended as additional treatment options for pain control.
In October 2005, a new topical nonsteroidal anti-inflammatory drop, Nevanac, was approved by the FDA. Nevanac was approved with a a TID dosing schedule.
Acular LS is the current market leader for topical NSAID eye drops. Acular LS is typically used on a QID dosing schedule.
- Being tested
- ketorolac (Acular LS), Nepafenac (Nevanac)
- Keywords
- PRK, laser vision correction, surface ablation, pain, wound healing, corneal haze
- Medical subject headings
- Myopia, Hyperopia, Pain, Corneal Opacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketorolac (Acular LS)Drug
Nepafenac (Nevanac)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of postoperative discomfort on postoperative days 1 to 5 after PRK
Best-corrected Visual acuity at all study visits
Degree of corneal haze at all study visits
Time to epithelial closure in each eye after PRK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJan 2006
- Study completionJun 2006
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Center For Excellence In Eye Care
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Investigators
- William Trattler, MD, Principal investigator, Center For Excellence In Eye Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347204
- Sponsor's protocol ID
- 5225
- Status last verified
- Jun 2006
- First submitted
- 29 Jun 2006
- Last updated
- 4 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Masked Evaluation of Acular LS Versus Nevanac for Postoperative Pain Control in Eyes Undergoing PRK
- ClinicalTrials.gov ID
- NCT00347204
- Acronym / sponsor ID
- 5225
- Keywords
- PRK, laser vision correction, surface ablation, pain, wound healing, corneal haze
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Center For Excellence In Eye CareUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jan 2006
- Study completion
- Jun 2006
- First posted
- 4 Jul 2006 (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.
To determine the ability of two topical Nonsteroidal Anti-inflammatory drops (Acular LS \& Nevanac) to help control pain following Photorefractive Keratectomy (PRK).
Detailed description
Laser Vision Correction is the most commonly performed elective surgical procedure in the United States. Although Laser-Assisted in-situ Keratomileusis (LASIK) is the more popular technique, a growing number of surgeons have switched to surface ablation techniques, including PRK, LASEK and Epi-LASIK.1 With surface laser procedures, the corneal epithelium is removed by a variety of techniques (laser, manual debridement, diluted alcohol2,3, epi-keatome) prior to laser reshaping of the corneal stroma. Following the procedure, a contact lens is placed on the eye to promote epithelial regeneration. Due to the size of the epithelial defect, it can take between 3 to 6 days for the epithelium to regenerate. During this healing process, patients often complain of moderate to severe ocular pain, and delayed healing may result in an increased risk of infection or corneal haze4.
Over the past decade, a variety of methods have been used to assist with reducing pain following surface laser procedures. Topical Nonsteroidals have been shown in a number of studies to help reduce the degree of pain following PRK. Topical dilute tetracaine has also been shown to assist with the reduction of pain following PRK. Oral pain medications, such as Vioxx, Celebrex, and even Prednisone have been recommended as additional treatment options for pain control.
In October 2005, a new topical nonsteroidal anti-inflammatory drop, Nevanac, was approved by the FDA. Nevanac was approved with a a TID dosing schedule.
Acular LS is the current market leader for topical NSAID eye drops. Acular LS is typically used on a QID dosing schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing PRK for myopia or hyperopia
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| ketorolac (Acular LS) | Drug | – |
| Nepafenac (Nevanac) | Drug | – |
Primary outcome
Prevention of postoperative discomfort on postoperative days 1 to 5 after PRK
Best-corrected Visual acuity at all study visits
Degree of corneal haze at all study visits
Time to epithelial closure in each eye after PRK
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 4 Jul 2006.
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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.
William Trattler, MD principal investigator
Center For Excellence In Eye Care
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ketorolac (Acular LS) and Nepafenac (Nevanac) in people with Myopia and Hyperopia, run by Center For Excellence In Eye Care.
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 1 inclusion and 1 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 4 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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?
Prevention of postoperative discomfort on postoperative days 1 to 5 after PRK. The study lists 4 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 4 Jul 2006.