Glaucoma, Open-AnglePhase 4NCT00781300
Intraocular Pressure With Loteprednol and Dexamethasone
A Phase 4 study testing Loteprednol Etabonate 0.5% and Dexamethasone 0.1% in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to compare intraocular pressure (IOP) changes after pterygium surgery among patients using loteprednol and dexamethasone during the postoperative period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- Loteprednol Etabonate 0.5% and Dexamethasone 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2006to Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: eighteen years old or more
- IOP: less than 22mmHg
Who cannot join
- History of previous ocular surgery
- Use of topical or systemic corticosteroids for up to a month before the surgery
- Extensive pterygia that disabled accurate IOP measurement
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Opthalmology, Federal University of São Paulo
São Paulo, São Paulo, 04023-062
About this study
Official title: A Randomized Clinical Trial Comparing the Intraocular Pressure Changes With the Use of Loteprednol and Dexamethasone After Pterygium Surgery
The purpose of this study is to compare intraocular pressure (IOP) changes after pterygium surgery among patients using loteprednol and dexamethasone during the postoperative period.
Read the detailed description
Surgical management of pterygium is known to initiate an inflammatory process with different levels of intensity. Corticosteroids are anti-inflammatory agents used to reduce the inflammatory process observed after surgical interventions including after pterygium surgery. However, use of topical corticosteroids can induce an elevation in intraocular pressure (IOP) due to a reduction in the facility of aqueous outflow.
Loteprednol etabonate (LE) was designed to maintain the anti-inflammatory efficiency of corticosteroids while lowering the risk of inducing IOP elevation. LE showed less effect on IOP than Prednisolone Acetate. This probably occurs due to lower levels of LE in the aqueous humor.
Some trials compare LE to other corticosteroids or placebo in treatments of the anterior uveitis, allergic conjunctivitis and cataract surgery. To our knowledge, there are no trials studying the effect of LE on IOP after pterygium surgery.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- Loteprednol Etabonate 0.5%, Dexamethasone 0.1%
- Keywords
- Intraocular pressure, Pterygium, Surgery, Steroids, Glaucoma
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Pterygium, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loteprednol Etabonate 0.5%Drug
Also called Loteprol, Lotemax
Patients in the Loteprednol Group received Loteprednol Etabonate 0.5% associated with Tobramycin 0.3% in separate eyedrops for four weeks: 6 times a day during the first postoperative week, 4 times a day during the second week, 3 times a day during the third week and twice-daily during the fourth week
Dexamethasone 0.1%Drug
Also called Tobradex
The patients in Dexamethasone Group received Dexamethasone 0.1% associated with Tobramycin 0.3% in a single eyedrop for four weeks: 6 times a day during the first postoperative week, 4 times a day during the second week, 3 times a day during the third week and twice-daily during the fourth week.
| Study group | Role | What they receive |
|---|---|---|
| Loteprednol | Active comparator | Not described Receives: Drug: Loteprednol Etabonate 0.5% |
| Dexamethasone | Active comparator | Not described Receives: Drug: Dexamethasone 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
Measured: Once a week for the first 4 weeks and 6 weeks after the procedure
Secondary outcomes (1)
IOP difference between the operated eye and the fellow eye
Measured: Once a week for the first 4 weeks and then 6 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startMar 2006
- Primary completionNov 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Luciano M Pinto, MD, Principal investigator, Fedreal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781300
- Sponsor's protocol ID
- CEP 1104/03
- Status last verified
- Oct 2008
- First submitted
- 27 Oct 2008
- Last updated
- 28 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing the Intraocular Pressure Changes With the Use of Loteprednol and Dexamethasone After Pterygium Surgery
- ClinicalTrials.gov ID
- NCT00781300
- Acronym / sponsor ID
- CEP 1104/03
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Keywords
- Intraocular pressure, Pterygium, Surgery, Steroids, Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 28 Oct 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.
The purpose of this study is to compare intraocular pressure (IOP) changes after pterygium surgery among patients using loteprednol and dexamethasone during the postoperative period.
Detailed description
Surgical management of pterygium is known to initiate an inflammatory process with different levels of intensity. Corticosteroids are anti-inflammatory agents used to reduce the inflammatory process observed after surgical interventions including after pterygium surgery. However, use of topical corticosteroids can induce an elevation in intraocular pressure (IOP) due to a reduction in the facility of aqueous outflow.
Loteprednol etabonate (LE) was designed to maintain the anti-inflammatory efficiency of corticosteroids while lowering the risk of inducing IOP elevation. LE showed less effect on IOP than Prednisolone Acetate. This probably occurs due to lower levels of LE in the aqueous humor.
Some trials compare LE to other corticosteroids or placebo in treatments of the anterior uveitis, allergic conjunctivitis and cataract surgery. To our knowledge, there are no trials studying the effect of LE on IOP after pterygium surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loteprednol | Active comparator | Drug: Loteprednol Etabonate 0.5% |
| Dexamethasone | Active comparator | Drug: Dexamethasone 0.1% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: eighteen years old or more
- IOP: less than 22mmHg
Key exclusion criteria (3 listed)
- History of previous ocular surgery
- Use of topical or systemic corticosteroids for up to a month before the surgery
- Extensive pterygia that disabled accurate IOP measurement
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 |
|---|---|---|
| Loteprednol Etabonate 0.5%Also: Loteprol, LotemaxPatients in the Loteprednol Group received Loteprednol Etabonate 0.5% associated with Tobramycin 0.3% in separate eyedrops for four weeks: 6 times a day during the first postoperative week, 4 times a day during the second week, 3 times a day during the third week and twice-daily during the fourth week | Drug | Loteprednol |
| Dexamethasone 0.1%Also: TobradexThe patients in Dexamethasone Group received Dexamethasone 0.1% associated with Tobramycin 0.3% in a single eyedrop for four weeks: 6 times a day during the first postoperative week, 4 times a day during the second week, 3 times a day during the third week and twice-daily during the fourth week. | Drug | Dexamethasone |
Primary outcome
Intraocular Pressure (IOP)
Time frame: Once a week for the first 4 weeks and 6 weeks after the procedure
1 secondary outcome
IOP difference between the operated eye and the fellow eye
Time frame: Once a week for the first 4 weeks and then 6 weeks after the procedure
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 28 Oct 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.
Luciano M Pinto, MD principal investigator
Fedreal University of São Paulo
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 Loteprednol Etabonate 0.5% and Dexamethasone 0.1% in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Federal University of São Paulo at 1 site in Brazil.
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 3 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 28 Oct 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 Brazil. 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.
What does the primary outcome measure?
Intraocular Pressure (IOP) (time frame: Once a week for the first 4 weeks and 6 weeks after the procedure). 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 28 Oct 2008.