Intraocular Pressure (IOP)Phase 4LATANOPROSTNCT01580254
Efficacy and Safety of Three Different Latanoprost 0,005% Eyedrops in Subjects Affected by Primary Open Angle Glaucoma
A Phase 4 study testing IOPIZE© Latanoprost eyedrops, GALAXIA© Latanoprost eyedrops and Latanoprost RATIOPHARM© latanoprost eyedrops in people with Intraocular Pressure (IOP) and Tear Break-Up Time, run by University of Catanzaro at 1 site in Italy.
Trial summary
This study examines efficacy and tolerability of 3 different Latanoprost 0.005% eyedrops preparations, commercially available in Italy, in subjects affected by primary open angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intraocular Pressure (IOP), Tear Break-Up Time
- What is being tested?
- IOPIZE© Latanoprost eyedrops, GALAXIA© Latanoprost eyedrops and Latanoprost RATIOPHARM© latanoprost eyedrops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2011to Jul 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ranged between 18 and 80
- Untreated IOP ranged between 21 and 30 mmHg
- IOP already treated with a single drug (monotherapy) ranged between 10 and 28 mmHg
Who cannot join
- History of adverse events or any controindication to drugs administred during sperimentation, i. e. Latanoprost and Timolol.
- Narrow or closed iridocorneal angle.
- History of acute angle-closure glaucoma.
- Previous laser trabeculoplasty within 3 months before screening.
- Severe visual field defects within 10° from fixation in at least one eye (at least 2 points with a p<0,5 in a pattern deviation map obtained from a reliable 24-2 Sita Standard SAP).
- History of refractive surgery or any keratoplasty procedure, corneal opacities or diseases that make not suitable applanation tonometry.
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- Use of contact lenses.
- BCVA less than 20/200.
- Ocular inflammation/infection occurring within three months before screening.
- History of bradicardia, systemic hypotension, bundle branch or any atrio-ventricular block
- Asthma
- Women of childbearing potential who were not using adequate contraceptive methods or who were pregnant or nursing
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Catanzaro - Eye Department
Catanzaro, Catanzaro, 88100
Luigi Varano, M.D., +3909613647365, luigi-varano@libero.it
Giovanni Scorcia, M. D., +3909613647135, scorcia@unicz.it
About this study
Official title: Phase 4 Study to Evaluate Efficacy And Safety of Three Different Preparations of Latanoprost 0,005% Eyedrops in Subjects Affected by Primary Open Angle Glaucoma
This study examines efficacy and tolerability of 3 different Latanoprost 0.005% eyedrops preparations, commercially available in Italy, in subjects affected by primary open angle glaucoma.
Read the detailed description
Prospective, randomized, single blinded study of the duration of 3 months, involving subjects affected by POAG or OH under therapy with different Latanoprost drugs (Galaxia, Iopize or Latanoprost Rathiopharm).
A total of 120 patients affected by POAG or OH newly diagnosed or already under topical therapy. will be recruited.
After a recruitment visit to assest eligibility of each subject, a "run-in" therapy composed of timolol 0,5% 2 drops per day will be prescribed for 4 weeks.
Then a baseline visit will be performed to evaluate IOP values and adverse effects in each subject. All subjects elegible for a therapy with a single dose of Latanoprost will be randomized into 3 arms.
After 4 weeks of therapy a second visit will be made to assest IOP changes and safety. Therapy will be continued for another 4 weeks, and after that, a final visit will be made.
- Conditions
- Intraocular Pressure (IOP), Tear Break-Up Time
- Being tested
- IOPIZE© Latanoprost eyedrops, GALAXIA© Latanoprost eyedrops, Latanoprost RATIOPHARM© latanoprost eyedrops
- Keywords
- Latanoprost, IOP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOPIZE© Latanoprost eyedropsDrug
Also called IOPIZE© eyedrops (S.I.F.I. S.p.A. - Aci S. Antonio (CT), Italy), authorization numbers:, 039276011, 039276023
patients will receive in each eligible eye one drop of IOPIZE© Latanoprost eyedrops once a day, in the evening (8pm), for two months
GALAXIA© Latanoprost eyedropsDrug
Also called GALAXIA© eyedrops (ALFA INTES Industria Terapeutica Splendore S.r.l. - Casoria (NA), Italy), authorization number:, 038622015
patients will receive in each eligible eye one drop of GALAXIA© Latanoprost eyedrops once a day, in the evening (8pm), for two months
Latanoprost RATIOPHARM© latanoprost eyedropsDrug
Also called Latanoprost RATIOPHARM© eyedrops (RATIOPHARM GmbH - Ulm, Germany), authorization number:, 039468018/M
patients will receive in each eligible eye one drop of Latanoprost RATIOPHARM© Latanoprost eyedrops once a day, in the evening (8pm), for two months
| Study group | Role | What they receive |
|---|---|---|
| IOPIZE© eyedrops | Active comparator | subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is IOPIZE© Receives: Drug: IOPIZE© Latanoprost eyedrops |
| GALAXIA© eyedrops | Active comparator | subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is GALAXIA© Receives: Drug: GALAXIA© Latanoprost eyedrops |
| Latanoprost RATIOPHARM© eyedrops | Active comparator | subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is Latanoprost RATIOPHARM© Receives: Drug: Latanoprost RATIOPHARM© latanoprost eyedrops |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure (IOP) in mmHg
to evaluate intraocular pressure (IOP) reduction after one and two months treatment with latanoprost eyedrops
Measured: one month - two months
Secondary outcomes (1)
Tear Break-Up Time (BUT) expressed in seconds
After one and two months of therapy with latanoprost, tear BUT will be calculated, through the use of fluoresceine staining of the tear film.
Measured: one month - two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startJun 2011
- Primary completionJun 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular Pressure (IOP)Studies 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
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Varano, MD - Principal Investigator, University of Catanzaro
- Investigators
- Luigi Varano, M. D., Principal investigator, University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580254
- Sponsor's protocol ID
- GENERIC-LATANOPROST
- Acronym
- LATANOPROST
- Status last verified
- Apr 2012
- First submitted
- 17 Apr 2012
- Last updated
- 18 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study to Evaluate Efficacy And Safety of Three Different Preparations of Latanoprost 0,005% Eyedrops in Subjects Affected by Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT01580254
- Acronym / sponsor ID
- LATANOPROST / GENERIC-LATANOPROST
- Conditions
- Intraocular Pressure (IOP), Tear Break-Up Time
- Keywords
- Latanoprost, IOP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 18 Apr 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 examines efficacy and tolerability of 3 different Latanoprost 0.005% eyedrops preparations, commercially available in Italy, in subjects affected by primary open angle glaucoma.
Detailed description
Prospective, randomized, single blinded study of the duration of 3 months, involving subjects affected by POAG or OH under therapy with different Latanoprost drugs (Galaxia, Iopize or Latanoprost Rathiopharm).
A total of 120 patients affected by POAG or OH newly diagnosed or already under topical therapy. will be recruited.
After a recruitment visit to assest eligibility of each subject, a "run-in" therapy composed of timolol 0,5% 2 drops per day will be prescribed for 4 weeks.
Then a baseline visit will be performed to evaluate IOP values and adverse effects in each subject. All subjects elegible for a therapy with a single dose of Latanoprost will be randomized into 3 arms.
After 4 weeks of therapy a second visit will be made to assest IOP changes and safety. Therapy will be continued for another 4 weeks, and after that, a final visit will be made.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IOPIZE© eyedrops | Active comparator | Drug: IOPIZE© Latanoprost eyedropssubjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is IOPIZE© |
| GALAXIA© eyedrops | Active comparator | Drug: GALAXIA© Latanoprost eyedropssubjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is GALAXIA© |
| Latanoprost RATIOPHARM© eyedrops | Active comparator | Drug: Latanoprost RATIOPHARM© latanoprost eyedropssubjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is Latanoprost RATIOPHARM© |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ranged between 18 and 80
- Untreated IOP ranged between 21 and 30 mmHg
- IOP already treated with a single drug (monotherapy) ranged between 10 and 28 mmHg
Key exclusion criteria (12 listed)
- History of adverse events or any controindication to drugs administred during sperimentation, i. e. Latanoprost and Timolol.
- Narrow or closed iridocorneal angle.
- History of acute angle-closure glaucoma.
- Previous laser trabeculoplasty within 3 months before screening.
- Severe visual field defects within 10° from fixation in at least one eye (at least 2 points with a p<0,5 in a pattern deviation map obtained from a reliable 24-2 Sita Standard SAP).
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 |
|---|---|---|
| IOPIZE© Latanoprost eyedropsAlso: IOPIZE© eyedrops (S.I.F.I. S.p.A. - Aci S. Antonio (CT), Italy), authorization numbers:, 039276011, 039276023patients will receive in each eligible eye one drop of IOPIZE© Latanoprost eyedrops once a day, in the evening (8pm), for two months | Drug | IOPIZE© eyedrops |
| GALAXIA© Latanoprost eyedropsAlso: GALAXIA© eyedrops (ALFA INTES Industria Terapeutica Splendore S.r.l. - Casoria (NA), Italy), authorization number:, 038622015patients will receive in each eligible eye one drop of GALAXIA© Latanoprost eyedrops once a day, in the evening (8pm), for two months | Drug | GALAXIA© eyedrops |
| Latanoprost RATIOPHARM© latanoprost eyedropsAlso: Latanoprost RATIOPHARM© eyedrops (RATIOPHARM GmbH - Ulm, Germany), authorization number:, 039468018/Mpatients will receive in each eligible eye one drop of Latanoprost RATIOPHARM© Latanoprost eyedrops once a day, in the evening (8pm), for two months | Drug | Latanoprost RATIOPHARM© eyedrops |
Primary outcome
intraocular pressure (IOP) in mmHg
Time frame: one month - two months
to evaluate intraocular pressure (IOP) reduction after one and two months treatment with latanoprost eyedrops
1 secondary outcome
Tear Break-Up Time (BUT) expressed in seconds
Time frame: one month - two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 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.
Luigi Varano, M. D. principal investigator
University of Catanzaro
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 IOPIZE© Latanoprost eyedrops, GALAXIA© Latanoprost eyedrops and Latanoprost RATIOPHARM© latanoprost eyedrops in people with Intraocular Pressure (IOP) and Tear Break-Up Time, run by University of Catanzaro 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 3 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: status not confirmed, as of the sponsor's last update on 18 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luigi Varano, M. D. (+3909613647365, luigi-varano@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraocular pressure (IOP) in mmHg (time frame: one month - two months). 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 18 Apr 2012.