Open-angle GlaucomaPhase 4NCT00397241
24-hour Study of Dorzolamide/Timolol and Latanoprost/Timolol Fixed Combinations
A Phase 4 study testing Drug: dorzolamide/timolol, Drug: latanoprost/timolol and dorzolamide/timolol and latanoprost in people with Open-angle Glaucoma, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The primary objective of this crossover trial is to compare the 3-month mean 24-hour intraocular pressure (IOP) control and safety of dorzolamide/timolol fixed combination (DTFC) given twice daily, versus latanoprost/timolol fixed combination (LTFC) given in the evening and placebo given in the morning, versus… Read more about this study
- Who is it for?
- Ages 29 to 80 years
- Conditions the study is for
- Open-angle Glaucoma
- What is being tested?
- Drug: dorzolamide/timolol, Drug: latanoprost/timolol and dorzolamide/timolol and latanoprost
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2006to Dec 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 29 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive primary open-angle (POAG) and exfoliative glaucoma (XFG) patients will be recruited.
- Patients included will be older than 29 years
- Have early to moderate POAG, or XFG (less than 12 mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio)
- Will be on therapy with latanoprost for more than 3 months;
- Have at treated baseline IOP at 10:00 (two consecutive readings) greater than 21 mm Hg
- Have a reliable visual field (at least two visual fields with less than 30% fixation losses, false positives or negatives)
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- Have a best corrected distance Snellen visual acuity > 1/10
- Have corneal pachymetry within the 550 ± 55 μm range, understand the study instructions and are willing to attend all follow-up appointments
- Are willing to comply with study medication usage
- And have open, normal appearing angles
Who cannot join
- Patients will be excluded if they have: a risk for significant deterioration during the study
- Known previous history of lack of adequate response (< 10% reduction) to any topical glaucoma medication
- Less than 20% daytime IOP reduction on latanoprost;
- Systemic contraindications to topical beta-blockers (asthma, bradycardia, severe congestive heart disease)
- Known contraindications to prostaglandins, history of ocular herpetic disease, or cystoid macular edema
- History of trauma, inflammation, surgery or past use of steroids (within two months)
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- Severe dry eyes
- Use of contact lenses
- Signs of ocular infection, except blepharitis
- Corneal abnormality that may affect IOP measurements
- Unwillingness to accept the risk for hyperchromia of the iris or development of hypertrichosis
- And females of childbearing potential or lactating mothers
Trial locations and contacts
1 site in 1 country.
Greece1 site
Glaucoma Unit, A University Dept of Ophthalmology
Thessaloniki, 546 43
About this study
Official title: 24-hour IOP With DTFC and LTFC Monotherapies and the Adjunctive Therapy of DTFC and Latanoprost in Open-angle Glaucoma Insufficiently Controlled With Latanoprost Monotherapy.
The primary objective of this crossover trial is to compare the 3-month mean 24-hour intraocular pressure (IOP) control and safety of dorzolamide/timolol fixed combination (DTFC) given twice daily, versus latanoprost/timolol fixed combination (LTFC) given in the evening and placebo given in the morning, versus adjunctive therapy with DTFC given twice daily and latanoprost 0.005% given once in the evening in open-angle glaucoma patients who are insufficiently controlled with latanoprost monotherapy.
- Conditions
- Open-angle Glaucoma
- Being tested
- Drug: dorzolamide/timolol, Drug: latanoprost/timolol, dorzolamide/timolol and latanoprost, placebo (artificial tears)
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: dorzolamide/timololDrug
Drug: latanoprost/timololDrug
dorzolamide/timolol and latanoprostDrug
placebo (artificial tears)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour IOP control with DTFC will be statistically similar with LTFC given once each evening and placebo in the morning.
Adjunctive therapy with DTFC and latanoprost will provide significantly better 24-hour IOP control than both fixed combinations alone (DTFC and LTFC).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AGP Konstas, Aristotle University Of Thessaloniki
- Investigators
- Anastasios GP Konstas, MD, PhD, Principal investigator, Glaucoma Unit, A University Department of Ophthalmology, AHEPA Hospital, Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397241
- Sponsor's protocol ID
- A733
- Status last verified
- Dec 2020
- First submitted
- 6 Nov 2006
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 24-hour IOP With DTFC and LTFC Monotherapies and the Adjunctive Therapy of DTFC and Latanoprost in Open-angle Glaucoma Insufficiently Controlled With Latanoprost Monotherapy.
- ClinicalTrials.gov ID
- NCT00397241
- Acronym / sponsor ID
- A733
- Conditions
- Open-angle Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Sep 2006 (actual)
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 8 Nov 2006 (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 primary objective of this crossover trial is to compare the 3-month mean 24-hour intraocular pressure (IOP) control and safety of dorzolamide/timolol fixed combination (DTFC) given twice daily, versus latanoprost/timolol fixed combination (LTFC) given in the evening and placebo given in the morning, versus adjunctive therapy with DTFC given twice daily and latanoprost 0.005% given once in the evening in open-angle glaucoma patients who are insufficiently controlled with latanoprost monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 29 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Consecutive primary open-angle (POAG) and exfoliative glaucoma (XFG) patients will be recruited.
- Patients included will be older than 29 years
- Have early to moderate POAG, or XFG (less than 12 mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio)
- Will be on therapy with latanoprost for more than 3 months;
- Have at treated baseline IOP at 10:00 (two consecutive readings) greater than 21 mm Hg
Key exclusion criteria (12 listed)
- Patients will be excluded if they have: a risk for significant deterioration during the study
- Known previous history of lack of adequate response (< 10% reduction) to any topical glaucoma medication
- Less than 20% daytime IOP reduction on latanoprost;
- Systemic contraindications to topical beta-blockers (asthma, bradycardia, severe congestive heart disease)
- Known contraindications to prostaglandins, history of ocular herpetic disease, or cystoid macular edema
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 |
|---|---|---|
| Drug: dorzolamide/timolol | Drug | – |
| Drug: latanoprost/timolol | Drug | – |
| dorzolamide/timolol and latanoprost | Drug | – |
| placebo (artificial tears) | Drug | – |
Primary outcome
24-hour IOP control with DTFC will be statistically similar with LTFC given once each evening and placebo in the morning.
Adjunctive therapy with DTFC and latanoprost will provide significantly better 24-hour IOP control than both fixed combinations alone (DTFC and LTFC).
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 19 Dec 2020.
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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.
Anastasios GP Konstas, MD, PhD principal investigator
Glaucoma Unit, A University Department of Ophthalmology, AHEPA Hospital, Thessaloniki, Greece
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 Drug: dorzolamide/timolol, Drug: latanoprost/timolol and dorzolamide/timolol and latanoprost in people with Open-angle Glaucoma, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 10 inclusion and 12 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 19 Dec 2020. 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 Greece. 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?
24-hour IOP control with DTFC will be statistically similar with LTFC given once each evening and placebo in the morning.. The study lists 2 primary outcomes in all. 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 19 Dec 2020.