Cataract ExtractionPhase 4NCT00366691
Comparison of Acular LS With Lotemax to Prevent Inflammation After Cataract Surgery and Intraocular Lens Implantation
A Phase 4 study testing Acular LS and Lotemax in people with Cataract Extraction, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of Acular LS® and Lotemax® in the prevention of inflammation in the eye after cataract surgery. Acular LS is made by Allergan, Inc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Extraction
- What is being tested?
- Acular LS and Lotemax
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Sep 2007
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must have a visually significant age-related cataract, in the planned operated eye.
- 18 years of age or older.
- The vision in the fellow, unoperated eye should have a potential visual acuity of 20/40 or better as determined by the principal investigator.
- Patient must desire cataract extraction.
- Willing and able to comply with scheduled visits and other study procedures.
Who cannot join
- Advanced glaucomatous damage.
- Any abnormality preventing reliable applanation tonometry in operated eye.
- Contact lens use during the active treatment portion of the trial in the operated eye.
- Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis in either eye.
- Any history of allergic hypersensitivity or poor tolerance to any component of the preparations used in this trial.
- Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
Show all 12Show fewer
- Any clinically significant, serious or severe medical or psychiatric condition.
- Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
- Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye.
- Required use of other topical medications during the active portion of the trial except prophylactic antibiotic, topical lid care, tear replacement solutions or glaucoma medications.
- Other ocular surgery at the time of the cataract extraction.
- Use of topical or oral antiprostaglandins or corticosteroids as well as aspirin products (> 81 mg) during the active treatment portion of the trial. If patient wants to participate in the trial and can stop the medication, he/she can be enrolled after 7-day wash out period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Storm Eye Institute, Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Comparison of Acular LS With Lotemax to Prevent Anterior Segment Inflammation After Phacoemulsification and Intraocular Lens Implantation
The purpose of this study is to compare the effectiveness of Acular LS® and Lotemax® in the prevention of inflammation in the eye after cataract surgery. Acular LS is made by Allergan, Inc. It is a nonsteroidal anti-inflammatory drug (NSAID) and is approved by the Food and Drug Administration (FDA) for use following cataract surgery. Lotemax is made by Bausch \& Lomb. It is a steroid and is also approved by the FDA for use following cataract surgery.
Read the detailed description
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAIDs) which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis (cyclo-oxigenase inhibitors). However, they leave the lipoxygenase pathway free to generate leukotrienes. This pharmacodynamic activity has been speculated as a reason why NSAIDs produce less ocular side effects than corticosteroids. It has been widely used in ophthalmology. In 1987, Flach1 published its effectiveness in the treatment of aphakic and pseudophakic macular edema. Its efficacy after cataract surgery has been shown2 and it has been compared to topical steroids after extra-capsular cataract extraction3,4,5 and phacoemulsification6,7. It has been used as analgesic after radial keratotomy(RK)8,9, photorefractive keratectomy (PRK)10 and laser in situ keratomileusis (LASIK)11
The purpose of this study is to compare the effectiveness of the NSAID ketorolac tromethamine ophthalmic solution 0.4% with the steroid loteprednol etabonate ophthalmic suspension 0.5% for preventing anterior segment inflammation after routine cataract surgery.
- Conditions
- Cataract Extraction
- Being tested
- Acular LS, Lotemax
- Keywords
- cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acular LSDrug
LotemaxDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startFeb 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract ExtractionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Investigators
- Kerry D Solomon, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366691
- Sponsor's protocol ID
- MRC-06-002
- Status last verified
- Jun 2006
- First submitted
- 17 Aug 2006
- Last updated
- 14 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Acular LS With Lotemax to Prevent Anterior Segment Inflammation After Phacoemulsification and Intraocular Lens Implantation
- ClinicalTrials.gov ID
- NCT00366691
- Acronym / sponsor ID
- MRC-06-002
- Conditions
- Cataract Extraction
- Keywords
- cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 21 Aug 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.
The purpose of this study is to compare the effectiveness of Acular LS® and Lotemax® in the prevention of inflammation in the eye after cataract surgery. Acular LS is made by Allergan, Inc. It is a nonsteroidal anti-inflammatory drug (NSAID) and is approved by the Food and Drug Administration (FDA) for use following cataract surgery. Lotemax is made by Bausch \& Lomb. It is a steroid and is also approved by the FDA for use following cataract surgery.
Detailed description
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAIDs) which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis (cyclo-oxigenase inhibitors). However, they leave the lipoxygenase pathway free to generate leukotrienes. This pharmacodynamic activity has been speculated as a reason why NSAIDs produce less ocular side effects than corticosteroids. It has been widely used in ophthalmology. In 1987, Flach1 published its effectiveness in the treatment of aphakic and pseudophakic macular edema. Its efficacy after cataract surgery has been shown2 and it has been compared to topical steroids after extra-capsular cataract extraction3,4,5 and phacoemulsification6,7. It has been used as analgesic after radial keratotomy(RK)8,9, photorefractive keratectomy (PRK)10 and laser in situ keratomileusis (LASIK)11
The purpose of this study is to compare the effectiveness of the NSAID ketorolac tromethamine ophthalmic solution 0.4% with the steroid loteprednol etabonate ophthalmic suspension 0.5% for preventing anterior segment inflammation after routine cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must have a visually significant age-related cataract, in the planned operated eye.
- 18 years of age or older.
- The vision in the fellow, unoperated eye should have a potential visual acuity of 20/40 or better as determined by the principal investigator.
- Patient must desire cataract extraction.
- Willing and able to comply with scheduled visits and other study procedures.
Key exclusion criteria (12 listed)
- Advanced glaucomatous damage.
- Any abnormality preventing reliable applanation tonometry in operated eye.
- Contact lens use during the active treatment portion of the trial in the operated eye.
- Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis in either eye.
- Any history of allergic hypersensitivity or poor tolerance to any component of the preparations used in this trial.
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 |
|---|---|---|
| Acular LS | Drug | – |
| Lotemax | Drug | – |
Primary outcome
Not reported in the source record.
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 14 Jun 2018.
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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.
Kerry D Solomon, MD principal investigator
Medical University of South Carolina
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 Acular LS and Lotemax in people with Cataract Extraction, run by Medical University of South Carolina 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 12 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 14 Jun 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 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.
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.
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 14 Jun 2018.