Primary Open Angle GlaucomaNCT00485108
Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty
A study testing prednisolone 1%, ketorolac 0.5% and Artificial Tears (Methyl cellulose drops) in people with Primary Open Angle Glaucoma and Pseudoexfoliation Glaucoma, run by Queen's University at 1 site in Canada.
Trial summary
The type of anti-inflammatory medication used post selective laser trabeculoplasty (SLT) may have an impact on the intra-ocular pressure (IOP) lowering effect of SLT. This study will evaluate the IOP lowering effect of SLT following the topical administration of one of the following: prednisolone 1%, ketorolac 0.5% or… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma
- What is being tested?
- prednisolone 1%, ketorolac 0.5% and Artificial Tears (Methyl cellulose drops)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to Dec 2014
- Phase
- Interventional
- 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
- primary open angle glaucoma, pseudo exfoliation glaucoma
Who cannot join
- previous incisional glaucoma surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty (SLT): A Randomized, Masked, Placebo Controlled Study
The type of anti-inflammatory medication used post selective laser trabeculoplasty (SLT) may have an impact on the intra-ocular pressure (IOP) lowering effect of SLT. This study will evaluate the IOP lowering effect of SLT following the topical administration of one of the following: prednisolone 1%, ketorolac 0.5% or artificial tears.
Read the detailed description
Patients who have been chosen to undergo SLT for glaucoma will be randomized to receive one of prednisolone 1%, ketorolac 0.5% or artificial tears four times a day for 5 days following administration of the laser treatment. The IOP will be measured at various time points following SLT: 1 hour, 2 days, 1 week, 1 month, 3 months, 6 months, and 1 year.
- Being tested
- prednisolone 1%, ketorolac 0.5%, Artificial Tears (Methyl cellulose drops)
- Keywords
- primary open angle glaucoma, pseudoexfoliation glaucoma, selective laser trabeculoplasty, intra ocular pressure, anti-inflammatory therapy, prednisolone acetate 1%, ketorolac tromethamine 0.5%
- Medical subject headings
- Glaucoma, Open-Angle, Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisolone 1%Drug
eye drop once in each eye treated, 4 times / day for 5 days post-laser
ketorolac 0.5%Drug
Also called Acular
eye drop once in each eye treated, 4 times / day for 5 days post-laser
Artificial Tears (Methyl cellulose drops)Drug
Also called Refresh Tears
eye drop once in each eye treated, 4 times / day for 5 days post-laser
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Prednisolone 1% eye drop Receives: Drug: prednisolone 1% |
| 2 | Active comparator | ketorolac 0.5% eye drop Receives: Drug: ketorolac 0.5% |
| 3 | Placebo comparator | Artificial Tears (methyl cellulose eye drop) Receives: Drug: Artificial Tears (Methyl cellulose drops) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure lowering effect
Measured: 1 hour, 2 days, 1 month, 3 months, 6 months and 1 year
Secondary outcomes (1)
intraocular pressure elevation
Measured: 1 hour, 2 days, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2007 (estimated)
- Study startJan 2007
- Primary completionJun 2009
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Glaucoma Research Society of Canada
- Responsible party
- Principal investigator, Dr. Robert Campbell, Queen's University
- Investigators
- Rob J Campbell, MD, MSc, Principal investigator, Queen's UniversityDelan Jinapriya, MD, Study director, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485108
- Sponsor's protocol ID
- DJ1
- Status last verified
- Sep 2015
- First submitted
- 9 Jun 2007
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty (SLT): A Randomized, Masked, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT00485108
- Acronym / sponsor ID
- DJ1
- Keywords
- primary open angle glaucoma, pseudoexfoliation glaucoma, selective laser trabeculoplasty, intra ocular pressure, anti-inflammatory therapy, prednisolone acetate 1%, ketorolac tromethamine 0.5%
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Pfizer, Glaucoma Research Society of Canada
- Study start
- Jan 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Jun 2007 (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 type of anti-inflammatory medication used post selective laser trabeculoplasty (SLT) may have an impact on the intra-ocular pressure (IOP) lowering effect of SLT. This study will evaluate the IOP lowering effect of SLT following the topical administration of one of the following: prednisolone 1%, ketorolac 0.5% or artificial tears.
Detailed description
Patients who have been chosen to undergo SLT for glaucoma will be randomized to receive one of prednisolone 1%, ketorolac 0.5% or artificial tears four times a day for 5 days following administration of the laser treatment. The IOP will be measured at various time points following SLT: 1 hour, 2 days, 1 week, 1 month, 3 months, 6 months, and 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: prednisolone 1%Prednisolone 1% eye drop |
| 2 | Active comparator | Drug: ketorolac 0.5%ketorolac 0.5% eye drop |
| 3 | Placebo comparator | Drug: Artificial Tears (Methyl cellulose drops)Artificial Tears (methyl cellulose eye drop) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary open angle glaucoma, pseudo exfoliation glaucoma
Key exclusion criteria (1 listed)
- previous incisional glaucoma surgery
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 |
|---|---|---|
| prednisolone 1%eye drop once in each eye treated, 4 times / day for 5 days post-laser | Drug | 1 |
| ketorolac 0.5%Also: Aculareye drop once in each eye treated, 4 times / day for 5 days post-laser | Drug | 2 |
| Artificial Tears (Methyl cellulose drops)Also: Refresh Tearseye drop once in each eye treated, 4 times / day for 5 days post-laser | Drug | 3 |
Primary outcome
Intraocular pressure lowering effect
Time frame: 1 hour, 2 days, 1 month, 3 months, 6 months and 1 year
1 secondary outcome
intraocular pressure elevation
Time frame: 1 hour, 2 days, 1 month
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 23 Sep 2015.
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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.
Rob J Campbell, MD, MSc principal investigator
Queen's University
Delan Jinapriya, MD study director
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prednisolone 1%, ketorolac 0.5% and Artificial Tears (Methyl cellulose drops) in people with Primary Open Angle Glaucoma and Pseudoexfoliation Glaucoma, run by Queen's University at 1 site in Canada.
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 23 Sep 2015. 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 Canada. 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?
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?
Intraocular pressure lowering effect (time frame: 1 hour, 2 days, 1 month, 3 months, 6 months and 1 year). 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 23 Sep 2015.