Open Angle GlaucomaNCT00478036
Comparing Acular LS and Pred Forte in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells
A study testing Acular LS, Pred Forte and Refresh Tears in people with Open Angle Glaucoma, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The Investigators will compare, in a randomized, prospective, masked and controlled fashion the effect of a non-steroidal anti-inflammatory agent (Acular LS), a corticosteroid (Pred Forte) and a placebo (Refresh Tears) on patient discomfort, degree of intraocular pressure (IOP) lowering and degree of ocular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Acular LS, Pred Forte and Refresh Tears
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jan 2014
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with open angle glaucoma patients at the Rocky Mountain Lions Eye Institute Glaucoma Clinic.
- Able to provide written informed consent to participate.
- Must be the age of 18 years of age or older.
- Patients in which further intraocular pressure lowering by selective laser trabeculoplasty is necessary in the opinion of the treating physician.
Who cannot join
- Patients with eye surgery in the prior six months.
- Patients with prior or current use of topical or systemic corticosteroids or NSAIDs.
- Patients with pre-existing anterior chamber inflammation.
- Patients with known sensitivity to any of the study medications.
- Due to the age range and the disease entity, special patient populations such as children or pregnant women will not be enrolled in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Eye Center
Aurora, Colorado, 80045
About this study
Official title: A Randomized Prospective Double Masked Controlled Trial Comparing Ketorolac Tromethamine 0.4% and Prednisolone Acetate 1% in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells.
The Investigators will compare, in a randomized, prospective, masked and controlled fashion the effect of a non-steroidal anti-inflammatory agent (Acular LS), a corticosteroid (Pred Forte) and a placebo (Refresh Tears) on patient discomfort, degree of intraocular pressure (IOP) lowering and degree of ocular inflammation following selective laser trabeculoplasty treatment for open angle glaucoma.
Read the detailed description
Currently, many ophthalmologists use anti-inflammatory agents like corticosteroids and nonsteroidal anti-inflammatory agents (NSAIDs) as a preventative measure to control the post-selective laser trabeculoplasty (SLT) anterior chamber inflammation. Both classes of compounds reduce inflammation through the inhibition of the cyclooxygenase pathway, whereas the corticosteroid class also inhibits the lipoxygenase pathway of the arachidonic acid cascade. Although effective, topical corticosteroids are associated with increase in intraocular pressure (IOP), posterior subcapsular cataract formation, and reduced response to infection. These adverse side effects have not been reported to occur with topical NSAIDs, which are effective in controlling the pain after SLT along with the prevention and suppression of the ocular inflammation. There are ophthalmologists who forgo using the anti-inflammatory agents post SLT and prescribe Refresh Tears to their patients to comfort the treated eye.
The significance of the study lies in assessing the efficacy of Acular LS, compared to Pred Forte and to Refresh Tears in reducing discomfort, inflammation and maximizing IOP lowering following SLT procedure for open angle glaucoma with the hope of resolving the dispute over the effective post-operative care in SLT patients.
- Conditions
- Open Angle Glaucoma
- Being tested
- Acular LS, Pred Forte, Refresh Tears
- Keywords
- glaucoma, selective laser trabeculoplasty, anterior chamber flare
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acular LSDrug
Also called KETOROLAC TROMETHAMINE 0.5% SOLUTION - OPHTHALMIC
Details covered in arm description
Pred ForteDrug
Also called Prednisolone acetate ophthalmic suspension 1%
Details covered in arm description
Refresh TearsOther
Also called CARBOXYMETHYLCELLULOSE SODIUM
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Acular LS | Active comparator | Acular LS - 1 drop in treated eye, 4 times a day, for 4 days Receives: Drug: Acular LS |
| Pred Forte | Active comparator | Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days Receives: Drug: Pred Forte |
| Refresh Tears | Placebo comparator | Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days Receives: Other: Refresh Tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interocular Pressure
IOP, measured by Goldmann applanation tonometry
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startMay 2007
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: insufficient enrollment
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 Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malik Y. Kahook, MD, Principal investigator, Rocky Mountain Lions Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478036
- Sponsor's protocol ID
- 06-1251
- Status last verified
- Aug 2016
- First submitted
- 23 May 2007
- Last updated
- 7 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Double Masked Controlled Trial Comparing Ketorolac Tromethamine 0.4% and Prednisolone Acetate 1% in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells.
- ClinicalTrials.gov ID
- NCT00478036
- Acronym / sponsor ID
- 06-1251
- Conditions
- Open Angle Glaucoma
- Keywords
- glaucoma, selective laser trabeculoplasty, anterior chamber flare
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient enrollment
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 May 2007 (estimated)
- Results
- Posted 7 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Investigators will compare, in a randomized, prospective, masked and controlled fashion the effect of a non-steroidal anti-inflammatory agent (Acular LS), a corticosteroid (Pred Forte) and a placebo (Refresh Tears) on patient discomfort, degree of intraocular pressure (IOP) lowering and degree of ocular inflammation following selective laser trabeculoplasty treatment for open angle glaucoma.
Detailed description
Currently, many ophthalmologists use anti-inflammatory agents like corticosteroids and nonsteroidal anti-inflammatory agents (NSAIDs) as a preventative measure to control the post-selective laser trabeculoplasty (SLT) anterior chamber inflammation. Both classes of compounds reduce inflammation through the inhibition of the cyclooxygenase pathway, whereas the corticosteroid class also inhibits the lipoxygenase pathway of the arachidonic acid cascade. Although effective, topical corticosteroids are associated with increase in intraocular pressure (IOP), posterior subcapsular cataract formation, and reduced response to infection. These adverse side effects have not been reported to occur with topical NSAIDs, which are effective in controlling the pain after SLT along with the prevention and suppression of the ocular inflammation. There are ophthalmologists who forgo using the anti-inflammatory agents post SLT and prescribe Refresh Tears to their patients to comfort the treated eye.
The significance of the study lies in assessing the efficacy of Acular LS, compared to Pred Forte and to Refresh Tears in reducing discomfort, inflammation and maximizing IOP lowering following SLT procedure for open angle glaucoma with the hope of resolving the dispute over the effective post-operative care in SLT patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acular LS | Active comparator | Drug: Acular LSAcular LS - 1 drop in treated eye, 4 times a day, for 4 days |
| Pred Forte | Active comparator | Drug: Pred FortePred Forte - 1 drop in treated eye, 4 times a day, for 4 days |
| Refresh Tears | Placebo comparator | Other: Refresh TearsRefresh Tears - 1 drop in treated eye, 4 times a day, for 4 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with open angle glaucoma patients at the Rocky Mountain Lions Eye Institute Glaucoma Clinic.
- Able to provide written informed consent to participate.
- Must be the age of 18 years of age or older.
- Patients in which further intraocular pressure lowering by selective laser trabeculoplasty is necessary in the opinion of the treating physician.
Key exclusion criteria (5 listed)
- Patients with eye surgery in the prior six months.
- Patients with prior or current use of topical or systemic corticosteroids or NSAIDs.
- Patients with pre-existing anterior chamber inflammation.
- Patients with known sensitivity to any of the study medications.
- Due to the age range and the disease entity, special patient populations such as children or pregnant women will not be enrolled in this study
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 LSAlso: KETOROLAC TROMETHAMINE 0.5% SOLUTION - OPHTHALMICDetails covered in arm description | Drug | Acular LS |
| Pred ForteAlso: Prednisolone acetate ophthalmic suspension 1%Details covered in arm description | Drug | Pred Forte |
| Refresh TearsAlso: CARBOXYMETHYLCELLULOSE SODIUMPlacebo | Other | Refresh Tears |
Primary outcome
Interocular Pressure
Time frame: 8 weeks
IOP, measured by Goldmann applanation tonometry
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- 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.
Malik Y. Kahook, MD principal investigator
Rocky Mountain Lions Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acular LS, Pred Forte and Refresh Tears in people with Open Angle Glaucoma, run by University of Colorado, Denver 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 4 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: stopped early, as of the sponsor's last update on 7 Oct 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2016). 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?
Interocular Pressure (time frame: 8 weeks). 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 7 Oct 2016.