Glaucoma, Open-AnglePhase 4NCT00647101
A Study to Assess the Efficacy of 3 Months of Latanoprost Treatment in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-angle Glaucoma
A Phase 4 study testing Latanoprost in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 176 sites in France.
Trial summary
The purpose of this study is to evaluate the effect of latanoprost on intraocular pressure reduction in patients with ocular hypertension or open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- Latanoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 176 sitesFrance
- Study dates
- Dec 2003to Feb 2005
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient with an IOP greater than or equal to 20 mmHg related to unilateral or bilateral OH or OAG (primary open angle glaucoma, pseudo-exfoliative glaucoma, and pigmentary glaucoma), after a visual field exam
- Naive patients (i.e. never having been treated) and requiring treatment initiation
Who cannot join
- A patient with OH or OAG currently on treatment
- A patient with OH or OAG previously treated (regardless of the date treatment was discontinued)
- A patient with traumatic, inflammatory, or neovascular glaucoma
Trial locations and contacts
176 sites in 1 country.
176 sites in 1 country
France176 sites
Pfizer Investigational Site
Albi, 81000
Pfizer Investigational Site
Ambert, 63600
Pfizer Investigational Site
Amboise, 37400
Pfizer Investigational Site
Angers, 49100
Pfizer Investigational Site
Antibes, 06600
Pfizer Investigational Site
Aubenas, 07200
Pfizer Investigational Site
Belfort, 90000
Pfizer Investigational Site
Bergerac, 24100
Pfizer Investigational Site
Bernay, 27300
Pfizer Investigational Site
Béthune, 62400
Pfizer Investigational Site
Béziers, 34500
Pfizer Investigational Site
Blagnac, 31700
Pfizer Investigational Site
Bordeaux, 33000
Pfizer Investigational Site
Bordeaux, 33100
Pfizer Investigational Site
Bougival, 78380
Pfizer Investigational Site
Boulogne-Billancourt, 92100
Pfizer Investigational Site
Brest, 29200
Pfizer Investigational Site
Bry-sur-Marne, 94360
Pfizer Investigational Site
Carentan, 50500
Pfizer Investigational Site
Cenon, 33150
Pfizer Investigational Site
Chamalières, 63400
Pfizer Investigational Site
Chantilly, 60500
Pfizer Investigational Site
Chartres, 28000
Pfizer Investigational Site
Châteaubriant, 44110
Pfizer Investigational Site
Châteaulin, 29150
Pfizer Investigational Site
Clermont-Ferrand, 63100
Pfizer Investigational Site
Condom, 32100
Pfizer Investigational Site
Coulommiers, 77120
Pfizer Investigational Site
Courbevoie, 92400
Pfizer Investigational Site
Creil, 60100
Pfizer Investigational Site
Deauville, 14800
Pfizer Investigational Site
Deuil-la-Barre, 95170
Pfizer Investigational Site
Douai, 59500
Pfizer Investigational Site
Draveil, 91210
Pfizer Investigational Site
Enghien-les-Bains, 95880
Pfizer Investigational Site
Épernay, 51200
Pfizer Investigational Site
Fontaine, 38600
Pfizer Investigational Site
Fréjus, 83600
Pfizer Investigational Site
Gennevilliers, 92230
Pfizer Investigational Site
Gradignan, 33170
Pfizer Investigational Site
Grasse, 06130
Pfizer Investigational Site
Grasse, 06135
Pfizer Investigational Site
Grenoble, 38000
Pfizer Investigational Site
Grenoble, 38100
Pfizer Investigational Site
Guingamp, 22200
Pfizer Investigational Site
Haguenau, 67500
Pfizer Investigational Site
Herblay-sur-Seine, 95220
Pfizer Investigational Site
Hyères, 83400
Pfizer Investigational Site
Issy-les-Moulineaux, 92130
Pfizer Investigational Site
Ivry-sur-Seine, 94210
Pfizer Investigational Site
Jarville-la-Malgrange, 5414
Pfizer Investigational Site
Joigny, 89300
Pfizer Investigational Site
Juvisy-sur-Orge, 91260
Pfizer Investigational Site
La Rochelle, 17000
Pfizer Investigational Site
La Talaudière, 42350
Pfizer Investigational Site
La Trinité, 06340
Pfizer Investigational Site
Landerneau, 29800
Pfizer Investigational Site
Langon, 33210
Pfizer Investigational Site
Lannion, 22300
Pfizer Investigational Site
Laon, 02000
Pfizer Investigational Site
Le Creuzot, 71200
Pfizer Investigational Site
Le Havre, 76600
Pfizer Investigational Site
Le Mans, 72000
Pfizer Investigational Site
Le Peage de Rousillon, 38550
Pfizer Investigational Site
Le Quesnoy, 59530
Pfizer Investigational Site
Lesneven, 29260
Pfizer Investigational Site
Lille, 59000
Pfizer Investigational Site
Livry-Gargan, 93190
Pfizer Investigational Site
Lunel, 34400
Pfizer Investigational Site
Lunéville, 54300
Pfizer Investigational Site
Luxeuil-les-Bains, 70300
Pfizer Investigational Site
Lyon, 69002
Pfizer Investigational Site
Lyon, 69006
Pfizer Investigational Site
Lyon, 69008
Pfizer Investigational Site
Lyon, 69437
Pfizer Investigational Site
Maisons-Laffitte, 78600
Pfizer Investigational Site
Marcq-en-Barœul, 59700
Pfizer Investigational Site
Marignanne, 13700
Pfizer Investigational Site
Marseille, 13001
Pfizer Investigational Site
Marseille, 13004
Pfizer Investigational Site
Marseille, 13008
Pfizer Investigational Site
Marseille, 13009
Pfizer Investigational Site
Marseille, 13012
Pfizer Investigational Site
Meyzieu, 69330
Pfizer Investigational Site
Montauban, 82000
Pfizer Investigational Site
Montceau-les-Mines, 71300
Pfizer Investigational Site
Montpellier, 34000
Pfizer Investigational Site
Mulhouse, 68200
Pfizer Investigational Site
Nantes, 44000
Pfizer Investigational Site
Nice, 06000
Pfizer Investigational Site
Nice, 06300
Pfizer Investigational Site
Nîmes, 30000
Pfizer Investigational Site
Nîmes, 30918
Pfizer Investigational Site
Niort, 79000
Pfizer Investigational Site
Nogent-sur-Marne, 94130
Pfizer Investigational Site
Noyon, 60400
Pfizer Investigational Site
Orléans, 45000
Pfizer Investigational Site
Oullins, 69600
Pfizer Investigational Site
Pantin, 93500
Pfizer Investigational Site
Paray-le-Monial, 71600
Pfizer Investigational Site
Paris, 75006
Pfizer Investigational Site
Paris, 75008
Pfizer Investigational Site
Paris, 75009
Pfizer Investigational Site
Paris, 75010
Pfizer Investigational Site
Paris, 75012
Pfizer Investigational Site
Paris, 75013
Pfizer Investigational Site
Paris, 75014
Pfizer Investigational Site
Paris, 75015
Pfizer Investigational Site
Paris, 75016
Pfizer Investigational Site
Paris, 75018
Pfizer Investigational Site
Paris, 75019
Pfizer Investigational Site
Paris, 75020
Pfizer Investigational Site
Paris, 75116
Pfizer Investigational Site
Pau, 64000
Pfizer Investigational Site
Pauillac, 33250
Pfizer Investigational Site
Périgueux, 24000
Pfizer Investigational Site
Perros Girec, 22700
Pfizer Investigational Site
Pézenas, 34120
Pfizer Investigational Site
Poissy, 78300
Pfizer Investigational Site
Poitiers, 86000
Pfizer Investigational Site
Pont-de-Chéruy, 38230
Pfizer Investigational Site
Pornic, 44210
Pfizer Investigational Site
Port-de-Bouc, 13110
Pfizer Investigational Site
Quimper, 29000
Pfizer Investigational Site
Reims, 51100
Pfizer Investigational Site
Rochefort, 17300
Pfizer Investigational Site
Romilly-sur-Seine, 10100
Pfizer Investigational Site
Saint Savine, 10300
Pfizer Investigational Site
Saint-Brieuc, 22015
Pfizer Investigational Site
Saint-Chamond, 42200
Pfizer Investigational Site
Saint-Dié, 88100
Pfizer Investigational Site
Saint-Etienne, 42000
Pfizer Investigational Site
Saint-Etienne, 42100
Pfizer Investigational Site
Saint-Gaudens, 31800
Pfizer Investigational Site
Saint-Lô, 50000
Pfizer Investigational Site
Saint-Michel-sur-Orge, 91240
Pfizer Investigational Site
Saintes, 17100
Pfizer Investigational Site
Salon-de-Provence, 13300
Pfizer Investigational Site
Sartrouville, 78500
Pfizer Investigational Site
Sens, 89100
Pfizer Investigational Site
Sessiney Pariset, 38170
Pfizer Investigational Site
Sète, 34200
Pfizer Investigational Site
Soissons, 02209
Pfizer Investigational Site
Strasbourg, 67000
Pfizer Investigational Site
Strasbourg, 67200
Pfizer Investigational Site
Suresnes, 92150
Pfizer Investigational Site
Talence, 33400
Pfizer Investigational Site
Thiers, 63300
Pfizer Investigational Site
Toulon, 83000
Pfizer Investigational Site
Toulouse, 31500
Pfizer Investigational Site
Toulouse, 34100
Pfizer Investigational Site
Tourcoing, 59200
Pfizer Investigational Site
Tournefeuille, 31170
Pfizer Investigational Site
Tours, 37000
Pfizer Investigational Site
Trélissac, 24750
Pfizer Investigational Site
Tremblay-en-France, 93290
Pfizer Investigational Site
Triel-sur-Seine, 78510
Pfizer Investigational Site
Troyes, 10000
Pfizer Investigational Site
Valenciennes, 59300
Pfizer Investigational Site
Vannes, 56000
Pfizer Investigational Site
Vauvert, 30600
Pfizer Investigational Site
Veauche, 42340
Pfizer Investigational Site
Velaux, 13800
Pfizer Investigational Site
Vendargues, 34740
Pfizer Investigational Site
Vénissieux, 69694
Pfizer Investigational Site
Viarmes, 95270
Pfizer Investigational Site
Vienne, 38200
Pfizer Investigational Site
Villeneuve-d'Ascq, 59650
Pfizer Investigational Site
Villeneuve-la-Garenne, 92390
Pfizer Investigational Site
Villeneuve-Saint-Georges, 94190
Pfizer Investigational Site
Villeparisis, 77270
Pfizer Investigational Site
Villepinte, 93420
Pfizer Investigational Site
Villiers-le-Bel, 95400
Pfizer Investigational Site
Vizille, 38220
Pfizer Investigational Site
Voiron, 38500
Pfizer Investigational Site
Wattrelos, 59150
About this study
Official title: Open Multicenter Study on the Efficacy of Xalatan at 3 Months as First-line Therapy in Naive Patients With Ocular Hypertension (OH) or Open Angle Glaucoma (OAG), Based on Initial Intraocular Pressure (IOP): 20 mmHg Less Than or Equal to IOP Less Than 24 mmHg, IOP Greater Than or Equal to 24 mmHg
The purpose of this study is to evaluate the effect of latanoprost on intraocular pressure reduction in patients with ocular hypertension or open-angle glaucoma.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- Latanoprost
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LatanoprostDrug
Latanoprost 0.005% drops: 1 drop in the diseased eye(s) in the evening for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Latanoprost group | Experimental | Not described Receives: Drug: Latanoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IOP after 3 months of treatment in absolute values (mmHg) compared to baseline IOP
Measured: 3 months
Secondary outcomes (7)
Change in IOP after 3 months of treatment in relative values (percentage of decrease) compared to baseline IOP
Measured: 3 months
Proportion of patients after 3 months of treatment with a relative reduction in IOP of greater than or equal to 30%, and greater than or equal to 10%
Measured: 3 months
Change in IOP after 1 month of treatment in absolute (mmHg) and relative values (percentage of decrease) relative to baseline IOP
Measured: 1 month
Proportion of patients after 1 month of treatment with a relative reduction in IOP of greater than or equal to 30%, and greater than or equal to 10%
Measured: 1 month
Proportion of patients after 3 months of treatment achieving the following target IOP values: IOP less than or equal to 21 mmHg, IOP less than or equal to 18 mmHg, IOP less than or equal to 15 mmHg
Measured: 3 months
Proportion of patients after 1 month of treatment achieving the following target IOP values: IOP less than or equal to 21 mmHg, IOP less than or equal to 18 mmHg, IOP less than or equal to 15 mmHg
Measured: 1 month
Occurrence of adverse events on latanoprost, local tolerability analysis by clinical exam
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startDec 2003
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647101
- Sponsor's protocol ID
- A6111002
- Other IDs
- X-FIL
- Status last verified
- Mar 2008
- First submitted
- 26 Mar 2008
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Denis P, Baudouin C, Bron A, Nordmann JP, Renard JP, Rouland JF, Sellem E, Amrane M. First-line latanoprost therapy in ocular hypertension or open-angle glaucoma patients: a 3-month efficacy analysis stratified by initial intraocular pressure. BMC Ophthalmol. 2010 Feb 24;10:4. doi: 10.1186/1471-2415-10-4.
PubMed 20181282
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Multicenter Study on the Efficacy of Xalatan at 3 Months as First-line Therapy in Naive Patients With Ocular Hypertension (OH) or Open Angle Glaucoma (OAG), Based on Initial Intraocular Pressure (IOP): 20 mmHg Less Than or Equal to IOP Less Than 24 mmHg, IOP Greater Than or Equal to 24 mmHg
- ClinicalTrials.gov ID
- NCT00647101
- Acronym / sponsor ID
- A6111002
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2003
- Study completion
- Feb 2005 (actual)
- First posted
- 31 Mar 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 evaluate the effect of latanoprost on intraocular pressure reduction in patients with ocular hypertension or open-angle glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Latanoprost group | Experimental | Drug: Latanoprost |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A patient with an IOP greater than or equal to 20 mmHg related to unilateral or bilateral OH or OAG (primary open angle glaucoma, pseudo-exfoliative glaucoma, and pigmentary glaucoma), after a visual field exam
- Naive patients (i.e. never having been treated) and requiring treatment initiation
Key exclusion criteria (3 listed)
- A patient with OH or OAG currently on treatment
- A patient with OH or OAG previously treated (regardless of the date treatment was discontinued)
- A patient with traumatic, inflammatory, or neovascular glaucoma
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 |
|---|---|---|
| LatanoprostLatanoprost 0.005% drops: 1 drop in the diseased eye(s) in the evening for 3 months | Drug | Latanoprost group |
Primary outcome
Change in IOP after 3 months of treatment in absolute values (mmHg) compared to baseline IOP
Time frame: 3 months
7 secondary outcomes
Change in IOP after 3 months of treatment in relative values (percentage of decrease) compared to baseline IOP
Time frame: 3 months
Proportion of patients after 3 months of treatment with a relative reduction in IOP of greater than or equal to 30%, and greater than or equal to 10%
Time frame: 3 months
Change in IOP after 1 month of treatment in absolute (mmHg) and relative values (percentage of decrease) relative to baseline IOP
Time frame: 1 month
Proportion of patients after 1 month of treatment with a relative reduction in IOP of greater than or equal to 30%, and greater than or equal to 10%
Time frame: 1 month
Proportion of patients after 3 months of treatment achieving the following target IOP values: IOP less than or equal to 21 mmHg, IOP less than or equal to 18 mmHg, IOP less than or equal to 15 mmHg
Time frame: 3 months
Proportion of patients after 1 month of treatment achieving the following target IOP values: IOP less than or equal to 21 mmHg, IOP less than or equal to 18 mmHg, IOP less than or equal to 15 mmHg
Time frame: 1 month
Occurrence of adverse events on latanoprost, local tolerability analysis by clinical exam
Time frame: 3 months
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 Feb 2021.
- Derived from this study: PubMed 20181282Denis P, Baudouin C, Bron A, Nordmann JP, Renard JP, Rouland JF, Sellem E, Amrane M. First-line latanoprost therapy in ocular hypertension or open-angle glaucoma patients: a 3-month efficacy analysis stratified by initial intraocular pressure. BMC Ophthalmol. 2010 Feb 24;10:4. doi: 10.1186/1471-2415-10-4.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
176 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Latanoprost in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 176 sites in France.
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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 176 sites in France. 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 IOP after 3 months of treatment in absolute values (mmHg) compared to baseline IOP (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00647101, which also lists 1 linked publication.
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 Feb 2021.