GlaucomaPhase 2/3NCT00853905
Will the Use of Triesence During Glaucoma Surgery Provide Lower Eye Pressure and Improve the Results of the Surgery?
A Phase 2/3 study testing Triesence and balanced salt solution BSS in people with Glaucoma, run by Wills Eye at 1 site in United States.
Trial summary
The investigators hypothesize that intracameral Triesence during glaucoma surgery will provide lower intraocular pressure through better control of ocular inflammation, thus leading to a more successful filtering procedure. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Triesence and balanced salt solution BSS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jan 2012
- Phase
- Phase 2/3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- glaucoma patients requiring surgery (Trabeculectomy or Express Shunt; Trabeculectomy plus Phacoemulsification and Interocular Lens Implant; Baerveldt Tube; Ahmed Tube; Molteno Tube)
- primary open angle glaucoma
- primary angle-closure glaucoma
- pseudoexfoliation glaucoma
- pigmentary glaucoma
- traumatic glaucoma
- neovascular glaucoma
Who cannot join
- patients that are pregnant, nursing, or not using adequate contraception
- any other eye surgery except cataract surgery
- an infection, inflammation, or any abnormality preventing measurement of eye pressure
- enrolled in another investigational study
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: The Effect of Intracameral Triesence (Triamcinolone Acetonide Injectable Suspension) on Ocular Inflammation After Trabeculectomy, Tube Shunt Implantation or Combined Trabeculectomy With Cataract Surgery
The investigators hypothesize that intracameral Triesence during glaucoma surgery will provide lower intraocular pressure through better control of ocular inflammation, thus leading to a more successful filtering procedure.
Read the detailed description
Determine the efficacy and safety of intracameral Triesence in patients who undergo trabeculectomy, tube shunt, or combined cataract extraction, intra-ocular lens implantation and trabeculectomy with or without adjunctive mitomycin-C.
- Conditions
- Glaucoma
- Being tested
- Triesence, balanced salt solution BSS
- Keywords
- open angle glaucoma (POAG), angle closure glaucoma (PACG), pigmentary glaucoma, pseudoexfoliation glaucoma, neovascular glaucoma, traumatic glaucoma
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Glaucoma, Angle-Closure, Exfoliation Syndrome, Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriesenceDrug
Also called triamcinolone acetonide injectable
At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.
balanced salt solution BSSDrug
Also called balanced salt solution
At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1(Triesence) | Experimental | glaucoma surgery with 0.2cc Triesence adjunct. Receives: Drug: Triesence |
| Treatment 2 (balanced salt solution BSS) | Active comparator | glaucoma surgery with balanced salt solution, the standard technique. Receives: Drug: balanced salt solution BSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
Intraocular pressure (IOP) was measured by applanation tonometry in millimeters of mercury (mmHg). Surgical success was determined if IOP was <21mmHg and 20% less than baseline IOP. Failure was defined as inability to meet criteria for success or IOP was less than 5mmHg.
Measured: 1 day, 1week, 1 month, 3 month and 6 month post-op visits
Secondary outcomes (4)
Anterior Chamber Inflammation (Flare)
Inflammation in the anterior chamber (called flare), is measured 10 times per eye using the flare meter, a non-invasive measurement. Flare meter measures inflammation in photon counts per millisecond (p/msec).
Measured: 1 month, 3 month and 6 month post-op visits
Bleb Appearance
A bleb is a blister on the white part of the eye (sclera) intentionally formed during some glaucoma surgeries. The Indiana Bleb Appearance Grading Scale (IBAGS) measures the bleb appearance in elevation (height), extent and vascularity. The height range is flat, low, moderate and high with 0 to 3 units on a scale. Zero is a flat bleb and 3 is a high bleb. Elevated functioning blebs increase the success of glaucoma surgery.
Measured: 1 day, 1 week, 1 month, 3 month and 6 month post-op visits
Patient Comfort
Questionnaire administered to capture feeling of dry eye. Dry eye was graded on a scale of absent, mild, moderate and severe with 0 to 3 units on a scale.
Measured: 1 day, 1 week, 1 month, 3 month and 6 month post-op visits
Ocular Hypotensive Medications
Number of ocular hypotensive ophthalmic solutions (eye drops) needed, if any, to maintain lower eye pressure.
Measured: 1 week, 1 month, 3 month, and or 6 month post-op visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2011
- Study completionJan 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Marlene Moster, MD, Wills Eye
- Investigators
- Marlene R Moster, MD, Principal investigator, Wills Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853905
- Sponsor's protocol ID
- 07-827
- Status last verified
- Jun 2018
- First submitted
- 27 Feb 2009
- Last updated
- 10 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Koval MS, Moster MR, Freidl KB, Waisbourd M, Jain SG, Ichhpujani P, Myers JS, Pro MJ. Intracameral triamcinolone acetonide in glaucoma surgery: a prospective randomized controlled trial. Am J Ophthalmol. 2014 Aug;158(2):395-401.e2. doi: 10.1016/j.ajo.2014.04.027. Epub 2014 May 2.
PubMed 24794283
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intracameral Triesence (Triamcinolone Acetonide Injectable Suspension) on Ocular Inflammation After Trabeculectomy, Tube Shunt Implantation or Combined Trabeculectomy With Cataract Surgery
- ClinicalTrials.gov ID
- NCT00853905
- Acronym / sponsor ID
- 07-827
- Conditions
- Glaucoma
- Keywords
- open angle glaucoma (POAG), angle closure glaucoma (PACG), pigmentary glaucoma, pseudoexfoliation glaucoma, neovascular glaucoma, traumatic glaucoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Feb 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Mar 2009 (estimated)
- Results
- Posted 21 Mar 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 hypothesize that intracameral Triesence during glaucoma surgery will provide lower intraocular pressure through better control of ocular inflammation, thus leading to a more successful filtering procedure.
Detailed description
Determine the efficacy and safety of intracameral Triesence in patients who undergo trabeculectomy, tube shunt, or combined cataract extraction, intra-ocular lens implantation and trabeculectomy with or without adjunctive mitomycin-C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment 1(Triesence) | Experimental | Drug: Triesenceglaucoma surgery with 0.2cc Triesence adjunct. |
| Treatment 2 (balanced salt solution BSS) | Active comparator | Drug: balanced salt solution BSSglaucoma surgery with balanced salt solution, the standard technique. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- glaucoma patients requiring surgery (Trabeculectomy or Express Shunt; Trabeculectomy plus Phacoemulsification and Interocular Lens Implant; Baerveldt Tube; Ahmed Tube; Molteno Tube)
- primary open angle glaucoma
- primary angle-closure glaucoma
- pseudoexfoliation glaucoma
- pigmentary glaucoma
Key exclusion criteria (4 listed)
- patients that are pregnant, nursing, or not using adequate contraception
- any other eye surgery except cataract surgery
- an infection, inflammation, or any abnormality preventing measurement of eye pressure
- enrolled in another investigational 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 |
|---|---|---|
| TriesenceAlso: triamcinolone acetonide injectableAt end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound. | Drug | Treatment 1(Triesence) |
| balanced salt solution BSSAlso: balanced salt solutionAt end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure. | Drug | Treatment 2 (balanced salt solution BSS) |
Primary outcome
Intraocular Pressure (IOP)
Time frame: 1 day, 1week, 1 month, 3 month and 6 month post-op visits
Intraocular pressure (IOP) was measured by applanation tonometry in millimeters of mercury (mmHg). Surgical success was determined if IOP was <21mmHg and 20% less than baseline IOP. Failure was defined as inability to meet criteria for success or IOP was less than 5mmHg.
4 secondary outcomes
Anterior Chamber Inflammation (Flare)
Time frame: 1 month, 3 month and 6 month post-op visits
Bleb Appearance
Time frame: 1 day, 1 week, 1 month, 3 month and 6 month post-op visits
Patient Comfort
Time frame: 1 day, 1 week, 1 month, 3 month and 6 month post-op visits
Ocular Hypotensive Medications
Time frame: 1 week, 1 month, 3 month, and or 6 month post-op visits
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24794283Koval MS, Moster MR, Freidl KB, Waisbourd M, Jain SG, Ichhpujani P, Myers JS, Pro MJ. Intracameral triamcinolone acetonide in glaucoma surgery: a prospective randomized controlled trial. Am J Ophthalmol. 2014 Aug;158(2):395-401.e2. doi: 10.1016/j.ajo.2014.04.027. Epub 2014 May 2.
- 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.
Marlene R Moster, MD principal investigator
Wills Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Triesence and balanced salt solution BSS in people with Glaucoma, run by Wills Eye 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 7 inclusion and 4 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 10 Jul 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 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?
Intraocular Pressure (IOP) (time frame: 1 day, 1week, 1 month, 3 month and 6 month post-op visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00853905, which also lists 1 linked publication.
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 10 Jul 2018.