Ocular HypertensionPhase 4NCT01655758
24-hour Control of Intraocular Pressure (IOP) in Ocular Hypertension
A Phase 4 study testing 0.5% timolol, timolol-dorzolamide fixed combination and Latanoprost in people with Ocular Hypertension, run by University of Parma at 1 site in Italy.
Trial summary
This study was designed to compare the 24-hour efficacy on intra ocular pressure (IOP) of drugs acting either on aqueous humor production ("inflow drugs") or on aqueous humor outflow ("outflow drugs") in human eyes affected by ocular hypertension and virgin to treatment. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Ocular Hypertension
- What is being tested?
- 0.5% timolol, timolol-dorzolamide fixed combination and Latanoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2002to Feb 2004
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IOP > 22 mmHg and < 30 mmHg on at least three readings on separate days ,
- Open angle on gonioscopy,
- CCT > 550 m,
- optic disk classified as "within normal limits" by Moorfields Regression analysis, HRTII,
- normal visual field (standard achromatic perimetry, Humphrey Field Analyzer, 24/2 SITA standard),
- Age > 40 and < 70 years,
- refraction between - 5 and + 2 dyopters,
- best corrected visual acuity better than 0.2 LogMAR,
Who cannot join
- PEX
- PDS
- ocular comorbidiities other than refractive problems and/or mild dry eye
- history of diabetes
- treatment with systemic beta blockers and steroids
- previous treatment with ocular hypotensive drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The 24 Control of IOP in Ocular Hypertension: a Cross-over Study on Inflow Versus Outflow Drugs.
This study was designed to compare the 24-hour efficacy on intra ocular pressure (IOP) of drugs acting either on aqueous humor production ("inflow drugs") or on aqueous humor outflow ("outflow drugs") in human eyes affected by ocular hypertension and virgin to treatment. The enrolled patients will be exposed, in a cross-over design, to n = 2 aqueous suppressants and n= 3 uveoscleral outflow enhancers, and 24 hr IOP will be measured. It is hypothesised that outflow drugs may offer a better and more stable control of IOP through the 24 hours.
Read the detailed description
(a) study design: Prospective, open label, investigator-masked clinical trial, with cross-over design, both eyes treated, OD chosen for analysis; (b) study population: patients, showing ocular hypertension, who were never exposed to hypotensive treatment (see inclusion and exclusion criteria for details). (c) study drugs: Timolol and dorzolamide will be chosen as inflow drugs. The three prostaglandin analogues (PGA) Latanoprost, travoprost and bimatoprost will be chosen as outflow drugs. (d) study flow-chart: upon enrollment, patients will be initiated to the following schedule: 60 days timolol 0.5% bid, 60 days washout, 60 days timolol 0.5%-dorzolamide 2% fixed combination bid, 60 days washout, 60 days PGA1, 60 days washout, 60 days PGA2, 60 days washout, 60 days PGA3. Patients were assigned to the PGAs according to a sequence (L-T-B) randomly generated. Data will be collected at baseline and at the and of each study phase (i.e. active treatment and washout)(e) main efficacy outcome: change in the mean IOP (with respect to baseline) at the end of each study phase and change of IOP (with respect to baseline) at the different time points of the 24-hour phasing. IOP will be measured at 8 a.m., 11 a.m., 3 p.m., 6 p.m. and 9 p.m. by means of Goldmann applanation tonometry at the slit lamp. At midnight, 2 a.m. and 6 a.m. the Tonopen in supine position will be used. (f) statistics: the analysis of co-variance (ANCOVA) for paired samples with Bonferroni correction will be adopted. A minimum sample size of 51 patients is needed for a minimal expected difference in mean IOP between inflow and outflow drugs = 2.5 mmHg, with an estimated pooled variance = 4 , a power = 90% and an alpha probability = 5%.
- Conditions
- Ocular Hypertension
- Being tested
- 0.5% timolol, timolol-dorzolamide fixed combination, Latanoprost, Travoprost, Bimatoprost
- Keywords
- glaucoma, 24-hour IOP, outflow drugs, inflow drugs
- Medical subject headings
- Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% timololDrug
Also called timoptol (MSD)
timolol-dorzolamide fixed combinationDrug
Also called cosopt (MSD)
LatanoprostDrug
Also called xalatan (pfizer)
TravoprostDrug
Also called travatan (Alcon)
BimatoprostDrug
Also called lumigan (Allergan)
| Study group | Role | What they receive |
|---|---|---|
| timolol | Active comparator | 60-day treatment phase with 0.5% timolol eyedrops, b.i.d. Receives: Drug: 0.5% timolol |
| 'timolol-dorzolamide fixed combination' | Active comparator | 60-day treatment phase with the fixed combination of 0.5% timolol-2% dorzolamide, eyedrops, b.i.d. Receives: Drug: timolol-dorzolamide fixed combination |
| xalatan | Active comparator | 60-day treatment phase with 0.005% latanoprost, eyedrops, QD Receives: Drug: Latanoprost |
| travatan | Active comparator | 60-day treatment phase with 0.004% travoprost, eyedrops, QD Receives: Drug: Travoprost |
| lumigan | Active comparator | 60-day treatment phase with 0.03% bimatoprost, eyedrops, QD Receives: Drug: Bimatoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the mean IOP at the end of each phase vs baseline, and change of IOP at the different time points of the 24-hour phasing with respect to baseline
Goldmann Applanation tonometry (GAT): 2 readings averaged. If >2 mmHg difference between the two, a further reading will be performed. GAT will be adopted during the day, and performed at the slit lamp in sitting position.
Tonopen: 4 readings averaged. Tonopen will be used during the night, and the measurements will be perfomred on patients laying in bed in supine position.
Measured: IOP will be measured, at baseline, on day 60, 120, 180, 240, 300, 360,420,480 and 540, at 8 a.m., 11 a.m., 3 p.m., 6 p.m., 9 p.m., midnight, 2 a.m. and 6 a.m.
Secondary outcomes (1)
visual field
Humphrey Field Analyzer, 24/2 SITA standard
Measured: visual field (24/2 SITA) will be performed at screening and at the end of the study (i.e. upon completion of the last cross-over arm, 540 days after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startJan 2002
- Primary completionDec 2003
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Gandolfi, University of Parma
- Investigators
- STEFANO GANDOLFI, MD, Principal investigator, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655758
- Sponsor's protocol ID
- UParma2004crossover
- Status last verified
- Jul 2012
- First submitted
- 21 Jul 2012
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 24 Control of IOP in Ocular Hypertension: a Cross-over Study on Inflow Versus Outflow Drugs.
- ClinicalTrials.gov ID
- NCT01655758
- Acronym / sponsor ID
- UParma2004crossover
- Conditions
- Ocular Hypertension
- Keywords
- glaucoma, 24-hour IOP, outflow drugs, inflow drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Dec 2003 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 2 Aug 2012 (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.
This study was designed to compare the 24-hour efficacy on intra ocular pressure (IOP) of drugs acting either on aqueous humor production ("inflow drugs") or on aqueous humor outflow ("outflow drugs") in human eyes affected by ocular hypertension and virgin to treatment. The enrolled patients will be exposed, in a cross-over design, to n = 2 aqueous suppressants and n= 3 uveoscleral outflow enhancers, and 24 hr IOP will be measured. It is hypothesised that outflow drugs may offer a better and more stable control of IOP through the 24 hours.
Detailed description
(a) study design: Prospective, open label, investigator-masked clinical trial, with cross-over design, both eyes treated, OD chosen for analysis; (b) study population: patients, showing ocular hypertension, who were never exposed to hypotensive treatment (see inclusion and exclusion criteria for details). (c) study drugs: Timolol and dorzolamide will be chosen as inflow drugs. The three prostaglandin analogues (PGA) Latanoprost, travoprost and bimatoprost will be chosen as outflow drugs. (d) study flow-chart: upon enrollment, patients will be initiated to the following schedule: 60 days timolol 0.5% bid, 60 days washout, 60 days timolol 0.5%-dorzolamide 2% fixed combination bid, 60 days washout, 60 days PGA1, 60 days washout, 60 days PGA2, 60 days washout, 60 days PGA3. Patients were assigned to the PGAs according to a sequence (L-T-B) randomly generated. Data will be collected at baseline and at the and of each study phase (i.e. active treatment and washout)(e) main efficacy outcome: change in the mean IOP (with respect to baseline) at the end of each study phase and change of IOP (with respect to baseline) at the different time points of the 24-hour phasing. IOP will be measured at 8 a.m., 11 a.m., 3 p.m., 6 p.m. and 9 p.m. by means of Goldmann applanation tonometry at the slit lamp. At midnight, 2 a.m. and 6 a.m. the Tonopen in supine position will be used. (f) statistics: the analysis of co-variance (ANCOVA) for paired samples with Bonferroni correction will be adopted. A minimum sample size of 51 patients is needed for a minimal expected difference in mean IOP between inflow and outflow drugs = 2.5 mmHg, with an estimated pooled variance = 4 , a power = 90% and an alpha probability = 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| timolol | Active comparator | Drug: 0.5% timolol60-day treatment phase with 0.5% timolol eyedrops, b.i.d. |
| 'timolol-dorzolamide fixed combination' | Active comparator | Drug: timolol-dorzolamide fixed combination60-day treatment phase with the fixed combination of 0.5% timolol-2% dorzolamide, eyedrops, b.i.d. |
| xalatan | Active comparator | Drug: Latanoprost60-day treatment phase with 0.005% latanoprost, eyedrops, QD |
| travatan | Active comparator | Drug: Travoprost60-day treatment phase with 0.004% travoprost, eyedrops, QD |
| lumigan | Active comparator | Drug: Bimatoprost60-day treatment phase with 0.03% bimatoprost, eyedrops, QD |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- IOP > 22 mmHg and < 30 mmHg on at least three readings on separate days ,
- Open angle on gonioscopy,
- CCT > 550 m,
- optic disk classified as "within normal limits" by Moorfields Regression analysis, HRTII,
- normal visual field (standard achromatic perimetry, Humphrey Field Analyzer, 24/2 SITA standard),
Key exclusion criteria (6 listed)
- PEX
- PDS
- ocular comorbidiities other than refractive problems and/or mild dry eye
- history of diabetes
- treatment with systemic beta blockers and steroids
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 |
|---|---|---|
| 0.5% timololAlso: timoptol (MSD) | Drug | timolol |
| timolol-dorzolamide fixed combinationAlso: cosopt (MSD) | Drug | 'timolol-dorzolamide fixed combination' |
| LatanoprostAlso: xalatan (pfizer) | Drug | xalatan |
| TravoprostAlso: travatan (Alcon) | Drug | travatan |
| BimatoprostAlso: lumigan (Allergan) | Drug | lumigan |
Primary outcome
change in the mean IOP at the end of each phase vs baseline, and change of IOP at the different time points of the 24-hour phasing with respect to baseline
Time frame: IOP will be measured, at baseline, on day 60, 120, 180, 240, 300, 360,420,480 and 540, at 8 a.m., 11 a.m., 3 p.m., 6 p.m., 9 p.m., midnight, 2 a.m. and 6 a.m.
Goldmann Applanation tonometry (GAT): 2 readings averaged. If >2 mmHg difference between the two, a further reading will be performed. GAT will be adopted during the day, and performed at the slit lamp in sitting position. Tonopen: 4 readings averaged. Tonopen will be used during the night, and the measurements will be perfomred on patients laying in bed in supine position.
1 secondary outcome
visual field
Time frame: visual field (24/2 SITA) will be performed at screening and at the end of the study (i.e. upon completion of the last cross-over arm, 540 days after baseline)
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 2 Aug 2012.
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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.
STEFANO GANDOLFI, MD principal investigator
University of Parma
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 0.5% timolol, timolol-dorzolamide fixed combination and Latanoprost in people with Ocular Hypertension, run by University of Parma at 1 site in Italy.
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 8 inclusion and 6 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 2 Aug 2012. 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 Italy. 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?
change in the mean IOP at the end of each phase vs baseline, and change of IOP at the different time points of the 24-hour phasing with respect to baseline (time frame: IOP will be measured, at baseline, on day 60, 120, 180, 240, 300, 360,420,480 and 540, at 8 a.m., 11 a.m., 3 p.m., 6 p.m., 9 p.m., midnight, 2 a.m. and 6 a.m.). 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 Aug 2012.