Uveitis, AnteriorPhase 4NCT01978015
Blood-aqueous Barrier Changes After the Use of Timolol and Prostaglandin Analogues Fixed Combination in Pseudophakic Patients With POAG
A Phase 4 study testing travoprost and timolol maleate fixed combination, latanoprost and maleate timolol fixed combination and bimatoprost and timolol maleate fixed combination in people with Uveitis, Anterior and Cystoid Macular Edema, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Glaucoma, a progressive optic disc neuropathy causing visual field reduction, is the second leading cause of world blindness. The treatment of glaucoma is mainly based in reducing intraocular pressure (IOP) with topical medications. Many patients required two or more medications to achieve a target IOP. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Uveitis, Anterior, Cystoid Macular Edema
- What is being tested?
- travoprost and timolol maleate fixed combination, latanoprost and maleate timolol fixed combination and bimatoprost and timolol maleate fixed combination
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2011to Jan 2013
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were eligible for participation if they met the following inclusion criteria: age older than 18 years, pseudophakia and diagnosis of primary open angle glaucoma (an untreated IOP levels of more then 21 mmHg, specific changes in the optic disc or specific visual fields changes. Optic disc changes were focal notching, optic disc haemorrhage, retinal nerve fiber layer (RNFL)defects, overpass-blood vessel crossing over an area of neuroretinal rim loss.Visual fields changes were the glaucoma hemifield test outside normal limits or a cluster of three or more non-edge points in a typical location of glaucoma or a corrected pattern standard deviation that occurs in less than 5% of normal visual fields
Who cannot join
- Exclusion criteria included history of uveitis or CME, substantial ocular irritation at baseline, or a history of intraocular surgery or a laser procedure within 6 months of baseline, the presence of systemic disorders that could be associated with uveitis or CME (ie, diabetes mellitus and rheumatologic diseases), presence of age-related macular degeneration and other macular diseases, pregnancy, breastfeeding, and inadequate contraception (in females), treatment with systemic beta-blocker, history of bronchial asthma, chronic obstructive pulmonary disease , sinus bradycardia, second and third degree atrioventricular block , sinoatrial block and functionally significant visual field loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood-aqueous Barrier Changes After the Use of Timolol and Prostaglandin Analogues Fixed Combination in Pseudophakic Patients With Primary Open Angle Glaucoma
Glaucoma, a progressive optic disc neuropathy causing visual field reduction, is the second leading cause of world blindness. The treatment of glaucoma is mainly based in reducing intraocular pressure (IOP) with topical medications. Many patients required two or more medications to achieve a target IOP. Combinations of B-blockers and prostaglandin analogs (PGA) are frequently used in clinical practice because their additive effect in lowering IOP levels. The aim of this study was to investigate the effects of fixed combinations of timolol maleate and PGA on the blood-aqueous barrier and evaluate the measurement of foveal thickness in pseudophakic patients with primary open-angle glaucoma (POAG).
Read the detailed description
Most studies found a lower incidence of systemic and ocular adverse events with fixed combinations than with the unfixed combinations. Fixed combinations are better tolerated than their respective prostaglandin analogue. However, among the most serious side effects induced by PGA are the breaking down of the blood-aqueous barrier (BAB) and the development of cystoids macular edema (CME). Also, timolol maleate drops increase protein concentration in the human and benzalkonium chloride, eye drops preservative induces anterior chamber inflammation. This randomized, masked-observer, prospective clinical trial was approved by the Ethics Committee of the University of Campinas, and it adhered to the tenets of the Declaration Of Helsinki. Written informed consent was obtained from each patient.
- Conditions
- Uveitis, Anterior, Cystoid Macular Edema
- Being tested
- travoprost and timolol maleate fixed combination, latanoprost and maleate timolol fixed combination, bimatoprost and timolol maleate fixed combination, dextran and hypromellose
- Keywords
- primary open angle glaucoma, timolol, prostaglandin analogues
- Medical subject headings
- Uveitis, Anterior, Macular Edema, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
travoprost and timolol maleate fixed combinationDrug
Also called Duo-travatan
travoprost 0.004% and timolol maleate 0,5%, 1 eye drop at 8p.m. for 6 months
latanoprost and maleate timolol fixed combinationDrug
Also called Xalacom
Latanoprost 0.005% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months
bimatoprost and timolol maleate fixed combinationDrug
Also called Ganfort
bimatoprost0.03% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months
dextran and hypromelloseDrug
Also called Lacribell
Dextran 70 and hypromellose, lubricant eye drop at 8 a.m and 8 p.m for 6 months
| Study group | Role | What they receive |
|---|---|---|
| latanoprost and timolol maleate fixed combination | Experimental | Latanoprost 0.005% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months Receives: Drug: latanoprost and maleate timolol fixed combination |
| bimatoprost and timolol maleate fixed combination | Experimental | bimatoprost 0.03% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months Receives: Drug: bimatoprost and timolol maleate fixed combination |
| dextran and hypromellose | Placebo comparator | A control group of patients with POAG and pseudophakic after trabeculectomy without medication. These patients received a lubricant drop twice daily at 8 a.m. and 8 p.m. for 6 months Receives: Drug: dextran and hypromellose |
| travoprost and timolol maleate fixed combination | Experimental | Travoprost 0.004% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months Receives: Drug: travoprost and timolol maleate fixed combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of mean flare values from baseline at 6 months
A flare measure of a laser flare meter (FM 500; Kowa Co Ltd, Tokyo, Japan) was used to determine the status of the blood-aqueous barrier at all follow-up visits. According to information provided by the manufacturer, flare readings greater than 26 photon counts per millisecond (p/ms) are indicative of a disruption in the blood-aqueous barrier.
Measured: Flare measurements occurred at baseline; after 15 days; and after 1, 2, 3, 4, 5, and 6 months of treatment
Secondary outcomes (1)
Change of mean macular thickness values from baseline at 6 months
Foveal macular thickness wiht Spectral Domain Optical Coherence Tomography (Cirrus Model 4000; Carl Zeiss Meditec, Dublin, California, USA) examination was conducted to investigate the occurrence of cystoid macular edema (CME). If CME was detected, the patient was instructed to discontinue taking the medication and a nonsteroidal anti-inflammatory drug was prescribed.
Measured: Macular optical coherence tomography images were taken at baseline, after one month and six months of treatment, or if a patient has reduced visual acuity during follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startOct 2011
- Primary completionJul 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveitis, AnteriorStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alana Mendonça de Santana, University of Campinas, Brazil
- Investigators
- Alana M Santana, MD, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978015
- Sponsor's protocol ID
- CEP424/2010
- Other IDs
- CAAE0319014600010
- Status last verified
- Oct 2013
- First submitted
- 25 Oct 2013
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood-aqueous Barrier Changes After the Use of Timolol and Prostaglandin Analogues Fixed Combination in Pseudophakic Patients With Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT01978015
- Acronym / sponsor ID
- CEP424/2010
- Conditions
- Uveitis, Anterior, Cystoid Macular Edema
- Keywords
- primary open angle glaucoma, timolol, prostaglandin analogues
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 7 Nov 2013 (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.
Glaucoma, a progressive optic disc neuropathy causing visual field reduction, is the second leading cause of world blindness. The treatment of glaucoma is mainly based in reducing intraocular pressure (IOP) with topical medications. Many patients required two or more medications to achieve a target IOP. Combinations of B-blockers and prostaglandin analogs (PGA) are frequently used in clinical practice because their additive effect in lowering IOP levels. The aim of this study was to investigate the effects of fixed combinations of timolol maleate and PGA on the blood-aqueous barrier and evaluate the measurement of foveal thickness in pseudophakic patients with primary open-angle glaucoma (POAG).
Detailed description
Most studies found a lower incidence of systemic and ocular adverse events with fixed combinations than with the unfixed combinations. Fixed combinations are better tolerated than their respective prostaglandin analogue. However, among the most serious side effects induced by PGA are the breaking down of the blood-aqueous barrier (BAB) and the development of cystoids macular edema (CME). Also, timolol maleate drops increase protein concentration in the human and benzalkonium chloride, eye drops preservative induces anterior chamber inflammation. This randomized, masked-observer, prospective clinical trial was approved by the Ethics Committee of the University of Campinas, and it adhered to the tenets of the Declaration Of Helsinki. Written informed consent was obtained from each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| latanoprost and timolol maleate fixed combination | Experimental | Drug: latanoprost and maleate timolol fixed combinationLatanoprost 0.005% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months |
| bimatoprost and timolol maleate fixed combination | Experimental | Drug: bimatoprost and timolol maleate fixed combinationbimatoprost 0.03% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months |
| dextran and hypromellose | Placebo comparator | Drug: dextran and hypromelloseA control group of patients with POAG and pseudophakic after trabeculectomy without medication. These patients received a lubricant drop twice daily at 8 a.m. and 8 p.m. for 6 months |
| travoprost and timolol maleate fixed combination | Experimental | Drug: travoprost and timolol maleate fixed combinationTravoprost 0.004% and timolol maleate 0,5% fixed combination was dropped once daily at 8 p.m. for 6 months |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients were eligible for participation if they met the following inclusion criteria: age older than 18 years, pseudophakia and diagnosis of primary open angle glaucoma (an untreated IOP levels of more then 21 mmHg, specific changes in the optic disc or specific visual fields changes. Optic disc changes were focal notching, optic disc haemorrhage, retinal nerve fiber layer (RNFL)defects, overpass-blood vessel crossing over an area of neuroretinal rim loss.Visual fields changes were the glaucoma hemifield test outside normal limits or a cluster of three or more non-edge points in a typical location of glaucoma or a corrected pattern standard deviation that occurs in less than 5% of normal visual fields
Key exclusion criteria (1 listed)
- Exclusion criteria included history of uveitis or CME, substantial ocular irritation at baseline, or a history of intraocular surgery or a laser procedure within 6 months of baseline, the presence of systemic disorders that could be associated with uveitis or CME (ie, diabetes mellitus and rheumatologic diseases), presence of age-related macular degeneration and other macular diseases, pregnancy, breastfeeding, and inadequate contraception (in females), treatment with systemic beta-blocker, history of bronchial asthma, chronic obstructive pulmonary disease , sinus bradycardia, second and third degree atrioventricular block , sinoatrial block and functionally significant visual field loss
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 |
|---|---|---|
| travoprost and timolol maleate fixed combinationAlso: Duo-travatantravoprost 0.004% and timolol maleate 0,5%, 1 eye drop at 8p.m. for 6 months | Drug | travoprost and timolol maleate fixed combination |
| latanoprost and maleate timolol fixed combinationAlso: XalacomLatanoprost 0.005% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months | Drug | latanoprost and timolol maleate fixed combination |
| bimatoprost and timolol maleate fixed combinationAlso: Ganfortbimatoprost0.03% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months | Drug | bimatoprost and timolol maleate fixed combination |
| dextran and hypromelloseAlso: LacribellDextran 70 and hypromellose, lubricant eye drop at 8 a.m and 8 p.m for 6 months | Drug | dextran and hypromellose |
Primary outcome
Change of mean flare values from baseline at 6 months
Time frame: Flare measurements occurred at baseline; after 15 days; and after 1, 2, 3, 4, 5, and 6 months of treatment
A flare measure of a laser flare meter (FM 500; Kowa Co Ltd, Tokyo, Japan) was used to determine the status of the blood-aqueous barrier at all follow-up visits. According to information provided by the manufacturer, flare readings greater than 26 photon counts per millisecond (p/ms) are indicative of a disruption in the blood-aqueous barrier.
1 secondary outcome
Change of mean macular thickness values from baseline at 6 months
Time frame: Macular optical coherence tomography images were taken at baseline, after one month and six months of treatment, or if a patient has reduced visual acuity during follow-up
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 7 Nov 2013.
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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.
Alana M Santana, MD principal investigator
University of Campinas, Brazil
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 travoprost and timolol maleate fixed combination, latanoprost and maleate timolol fixed combination and bimatoprost and timolol maleate fixed combination in people with Uveitis, Anterior and Cystoid Macular Edema, run by University of Campinas, Brazil 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 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 7 Nov 2013. 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. 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.
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?
Change of mean flare values from baseline at 6 months (time frame: Flare measurements occurred at baseline; after 15 days; and after 1, 2, 3, 4, 5, and 6 months of treatment). 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 Nov 2013.