Corneal EdemaPhase 3NCT00800423
Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema
A Phase 3 study testing Brimonidine Tartrate 0.2% and Timolol maleate 0.5% in people with Corneal Edema and Visual Acuity, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Most patients undergoing cataract surgery suffer from corneal edema after the surgery. Brimonidine drops are a well known and safe Anti-glaucoma medication. the investigators have made several clinical observations that patients receiving Brimonidine drops had a faster resolution of their corneal edema even if they… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Edema, Visual Acuity
- What is being tested?
- Brimonidine Tartrate 0.2% and Timolol maleate 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Jan 2010
- Phase
- Phase 3
- 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
- 1 day after uneventful cataract surgery
- corneal edema (grade 2 to 3)
Who cannot join
- glaucoma
- higher than normal intraocular pressure (>23 mm Hg)
- known sensitivity or contra indication to brimonidine
- known sensitivity or contra indication to timolol
- pre operative corneal or anterior segment disease
- intraoperative complications
Show all 9Show fewer
- major ocular pathology other than corneal that reduced vision (retinal degeneration, optic neuropathy etc.)
- pregnant women
- children
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rabin medical center ophthalmology deparment
Petah Tikva, 49100
Weinberger Dov, MD, 9729376101, dwin@clalit.org.il
Omer bialer, MD, 9729377171, omerb@clalit.org.il
About this study
Official title: Phase 3 Study of Brimonidine Tartrate Drops Efficacy in Reducing Post Operative Corneal Edema After Cataract Surgery
Most patients undergoing cataract surgery suffer from corneal edema after the surgery.
Brimonidine drops are a well known and safe Anti-glaucoma medication. the investigators have made several clinical observations that patients receiving Brimonidine drops had a faster resolution of their corneal edema even if they had normal intra-ocular pressure.
The investigators believe that administering topical Brimonidine to patients with significant post operative corneal edema will hasten the resolution of their corneal edema.
Read the detailed description
Most patients undergoing cataract surgery suffer from corneal edema after the surgery which temporarily reduces their visual acuity until corneal edema resolves over several weeks Brimonidine drops are a well known and safe Anti-glaucoma medication, used to lower intra ocular pressure.
there have been several clinical observations that patients receiving Brimonidine drops had a faster resolution of their corneal edema even in the presence of normal intra-ocular pressure.
The investigators postulated that administering topical Brimonidine to patients with significant post operative corneal edema will hasten their recovery and visual improvement.
In order to prove that Brimonidine drops contribute to faster resolution of cornel edema and visual improvement, the study will randomly compare 50 post cataract surgery patients (group A)who will be administered Brimonidine to 2 control groups (50 people in each group):
group B will be given topical timolol drops 0.5% (another well recognized anti glaucoma medication which reduces intra-ocular pressure by different mechanism than Brimonidine.
Group C will not be given any test drug. All 3 groups will receive the regular post operative medications which include corticosteroids and antibiotics.
- Conditions
- Corneal Edema, Visual Acuity
- Being tested
- Brimonidine Tartrate 0.2%, Timolol maleate 0.5%
- Keywords
- corneal edema, postoperative corneal edema, central corneal thickness, visual acuity, postoperative, brimonidine, timolol, cataract surgery
- Medical subject headings
- Corneal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine Tartrate 0.2%Drug
Also called ALPHAGAN P
Brimonidine Tartrate 0.2% drops
1 drop twice a day for 1 month in the operated eye
Timolol maleate 0.5%Drug
Also called TILOPTIC, V-OPTIC
timolol maleate 0.5% drops
1 drop twice a day for 1 month in the operated eye
| Study group | Role | What they receive |
|---|---|---|
| brimonidine | Experimental | 50 patients receiving Brimonidine Tartrate drops in the operated eye: 1 drop X2 a day for 1 month.
they will also be administered the usual medications after cataract surgery (corticosteroids and antibiotics drops) Receives: Drug: Brimonidine Tartrate 0.2% |
| 2 tmolol | Active comparator | 50 patients receiving timolol maleate 0.5% drops in the operated eye
1 drop X2 a day for 1 month. they will also be administered the usual medications after cataract surgery (corticosteroids and antibiotics drops) Receives: Drug: Timolol maleate 0.5% |
| 3 | No intervention | 50 patients will not receive any additional drug to the usual medications after cataract surgery (corticosteroids and antibiotics drops) |
What is being measured
The primary outcome is the main question the study is designed to answer.
central corneal thickness in micrometer
Measured: day 0 (day of enrollment ), day 7, day 30
Secondary outcomes (1)
grading of corneal edema (1-3)
Measured: day 0 (day of enrollment), day 7, day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionJan 2010 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EdemaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Anat Robinson, MD, Principal investigator, Rabin medical center, Clalit health services , Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800423
- Sponsor's protocol ID
- 5189
- Status last verified
- Nov 2008
- First submitted
- 30 Nov 2008
- Last updated
- 2 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Brimonidine Tartrate Drops Efficacy in Reducing Post Operative Corneal Edema After Cataract Surgery
- ClinicalTrials.gov ID
- NCT00800423
- Acronym / sponsor ID
- 5189
- Conditions
- Corneal Edema, Visual Acuity
- Keywords
- corneal edema, postoperative corneal edema, central corneal thickness, visual acuity, postoperative, brimonidine, timolol, cataract surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 2 Dec 2008 (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.
Most patients undergoing cataract surgery suffer from corneal edema after the surgery.
Brimonidine drops are a well known and safe Anti-glaucoma medication. the investigators have made several clinical observations that patients receiving Brimonidine drops had a faster resolution of their corneal edema even if they had normal intra-ocular pressure.
The investigators believe that administering topical Brimonidine to patients with significant post operative corneal edema will hasten the resolution of their corneal edema.
Detailed description
Most patients undergoing cataract surgery suffer from corneal edema after the surgery which temporarily reduces their visual acuity until corneal edema resolves over several weeks Brimonidine drops are a well known and safe Anti-glaucoma medication, used to lower intra ocular pressure.
there have been several clinical observations that patients receiving Brimonidine drops had a faster resolution of their corneal edema even in the presence of normal intra-ocular pressure.
The investigators postulated that administering topical Brimonidine to patients with significant post operative corneal edema will hasten their recovery and visual improvement.
In order to prove that Brimonidine drops contribute to faster resolution of cornel edema and visual improvement, the study will randomly compare 50 post cataract surgery patients (group A)who will be administered Brimonidine to 2 control groups (50 people in each group):
group B will be given topical timolol drops 0.5% (another well recognized anti glaucoma medication which reduces intra-ocular pressure by different mechanism than Brimonidine.
Group C will not be given any test drug. All 3 groups will receive the regular post operative medications which include corticosteroids and antibiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| brimonidine | Experimental | Drug: Brimonidine Tartrate 0.2%50 patients receiving Brimonidine Tartrate drops in the operated eye: 1 drop X2 a day for 1 month. they will also be administered the usual medications after cataract surgery (corticosteroids and antibiotics drops) |
| 2 tmolol | Active comparator | Drug: Timolol maleate 0.5%50 patients receiving timolol maleate 0.5% drops in the operated eye 1 drop X2 a day for 1 month. they will also be administered the usual medications after cataract surgery (corticosteroids and antibiotics drops) |
| 3 | No intervention | –50 patients will not receive any additional drug to the usual medications after cataract surgery (corticosteroids and antibiotics drops) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1 day after uneventful cataract surgery
- corneal edema (grade 2 to 3)
Key exclusion criteria (9 listed)
- glaucoma
- higher than normal intraocular pressure (>23 mm Hg)
- known sensitivity or contra indication to brimonidine
- known sensitivity or contra indication to timolol
- pre operative corneal or anterior segment disease
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 |
|---|---|---|
| Brimonidine Tartrate 0.2%Also: ALPHAGAN PBrimonidine Tartrate 0.2% drops 1 drop twice a day for 1 month in the operated eye | Drug | brimonidine |
| Timolol maleate 0.5%Also: TILOPTIC, V-OPTICtimolol maleate 0.5% drops 1 drop twice a day for 1 month in the operated eye | Drug | 2 tmolol |
Primary outcome
central corneal thickness in micrometer
Time frame: day 0 (day of enrollment ), day 7, day 30
1 secondary outcome
grading of corneal edema (1-3)
Time frame: day 0 (day of enrollment), day 7, day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2008.
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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.
Anat Robinson, MD principal investigator
Rabin medical center, Clalit health services , Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brimonidine Tartrate 0.2% and Timolol maleate 0.5% in people with Corneal Edema and Visual Acuity, run by Rabin Medical Center at 1 site in Israel.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 2 Dec 2008. 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 Israel. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anat Robinson, MD (9729377176, robina@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
central corneal thickness in micrometer (time frame: day 0 (day of enrollment ), day 7, day 30). 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 2 Dec 2008.