Primary Open Angle GlaucomaPhase 4NCT02047630
Efficacy of the Brand-name Latanoprost and One of Its Generic Version in Primary Open Angle Glaucoma and Ocular Hypertension
A Phase 4 study testing Generic latanoprost and Brand-name latanoprost in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate and compare efficacy and tolerability of the brand-name latanoprost and one of its generic version in subjects with primary open angle glaucoma or ocular hypertension. This randomized, double-blinded, cross-over design study has a 4 months follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Generic latanoprost and Brand-name latanoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to 4 Dec 2014
- 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
- >18 years old
- Primary open angle glaucoma, glaucoma suspect or ocular hypertension
- Bilateral
- Without any treatment or treated with latanoprost or another prostaglandin analog
- Intraocular pressure >21mmHg (without treatment or after a washout period)
Who cannot join
- Intraocular pressure >30mmHg
- Secondary glaucoma (uveitic, neovascular, traumatic ) or congenital glaucoma
- Pseudoexfoliation syndrome
- Pigmentary dispersion syndrome or Pigmentary glaucoma
- Severe glaucoma; Cup-to-disc ratio ≥9/10 OU Loss of central visual field (central 10°)
- Use of other topical medication to lower intraocular pressure
Show all 22Show fewer
- Pregnancy and breast-feeding
- Being allergic to latanoprost or benzalkonium chloride (BAK)
- Current use of acetazolamide (Diamox)
- Changes of systemic doses of beta-blockers during study
- Recent use of topical corticosteroids (<1 month)
- Contact lens wearer
- Closed angle at gonioscopy or past angle closure glaucoma
- Filtration surgery (example. : trabeculectomy)
- Selective Laser Trabeculoplasty (SLT) or Argon Laser Trabeculoplasty(ALT)
- Recent Intraocular surgery (<3 months)
- Refractive surgery
- Recent iridotomy or capsulotomy (<3 months)
- Past medical history of ocular trauma (example : angle recession)
- Past or active uveitis
- Herpetic keratitis
- Monocular vision
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
Québec, G1S 4L8
About this study
The purpose of this study is to evaluate and compare efficacy and tolerability of the brand-name latanoprost and one of its generic version in subjects with primary open angle glaucoma or ocular hypertension.
This randomized, double-blinded, cross-over design study has a 4 months follow-up. There are two periods of 8 weeks. During the first period, subjects put brand-name latanoprost in one eye and the generic version in the other one. In the second period, drops are switched from one eye to the other. There are intraocular pressure measurements (diurnal curves) on day 0 (before treatment), at 8 weeks (at the end of first period) and at 16 weeks (at the end of second period). Variations of intraocular pressure in each eye will be evaluated.
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Generic latanoprost, Brand-name latanoprost
- Keywords
- Primary open angle glaucoma, Ocular hypertension, latanoprost, generic, intraocular pressure
- 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.
Generic latanoprostDrug
Brand-name latanoprostDrug
Also called Xalatan
| Study group | Role | What they receive |
|---|---|---|
| Generic latanoprost | Experimental | 1 eye drop hs Receives: Drug: Generic latanoprost; Drug: Brand-name latanoprost |
| Brand-name latanoprost | Active comparator | 1 eye drop hs Receives: Drug: Generic latanoprost; Drug: Brand-name latanoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular Pressure (IOP)
Goldman applanation tonometry will be used to measure IOP.
Measured: 8 weeks, 16 weeks
Secondary outcomes (3)
Change in Conjunctival hyperemia
Measured: 8 weeks, 16 weeks
Change in corneal staining
Oxford grading scale
Measured: 8 weeks, 16 weeks
Change in TSS-IOP (Treatment Satisfaction Survey for IntraOcular Pressure)
Measured: 8 weeks, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJan 2014
- Primary completion4 Dec 2014
- Study completion4 Dec 2014
Why it stopped: Problem with IP supply
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Josée Fredette, CHU de Quebec-Universite Laval
- Investigators
- Marie-Josée Fredette, MD, FRCSC, Principal investigator, Centre de recherche du CHU de Québec; Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047630
- Sponsor's protocol ID
- C13-11-1242
- Status last verified
- Jul 2017
- First submitted
- 19 Jan 2014
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Brand-name Latanoprost and One of Its Generic Version in Primary Open Angle Glaucoma and Ocular Hypertension
- ClinicalTrials.gov ID
- NCT02047630
- Acronym / sponsor ID
- C13-11-1242
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Keywords
- Primary open angle glaucoma, Ocular hypertension, latanoprost, generic, intraocular pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Problem with IP supply
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 4 Dec 2014 (actual)
- Study completion
- 4 Dec 2014 (actual)
- First posted
- 28 Jan 2014 (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 and compare efficacy and tolerability of the brand-name latanoprost and one of its generic version in subjects with primary open angle glaucoma or ocular hypertension.
This randomized, double-blinded, cross-over design study has a 4 months follow-up. There are two periods of 8 weeks. During the first period, subjects put brand-name latanoprost in one eye and the generic version in the other one. In the second period, drops are switched from one eye to the other. There are intraocular pressure measurements (diurnal curves) on day 0 (before treatment), at 8 weeks (at the end of first period) and at 16 weeks (at the end of second period). Variations of intraocular pressure in each eye will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generic latanoprost | Experimental | Drug: Generic latanoprost, Drug: Brand-name latanoprost1 eye drop hs |
| Brand-name latanoprost | Active comparator | Drug: Generic latanoprost, Drug: Brand-name latanoprost1 eye drop hs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years old
- Primary open angle glaucoma, glaucoma suspect or ocular hypertension
- Bilateral
- Without any treatment or treated with latanoprost or another prostaglandin analog
- Intraocular pressure >21mmHg (without treatment or after a washout period)
Key exclusion criteria (22 listed)
- Intraocular pressure >30mmHg
- Secondary glaucoma (uveitic, neovascular, traumatic ) or congenital glaucoma
- Pseudoexfoliation syndrome
- Pigmentary dispersion syndrome or Pigmentary glaucoma
- Severe glaucoma; Cup-to-disc ratio ≥9/10 OU Loss of central visual field (central 10°)
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 |
|---|---|---|
| Generic latanoprost | Drug | Brand-name latanoprost, Generic latanoprost |
| Brand-name latanoprostAlso: Xalatan | Drug | Brand-name latanoprost, Generic latanoprost |
Primary outcome
Change in Intraocular Pressure (IOP)
Time frame: 8 weeks, 16 weeks
Goldman applanation tonometry will be used to measure IOP.
3 secondary outcomes
Change in Conjunctival hyperemia
Time frame: 8 weeks, 16 weeks
Change in corneal staining
Time frame: 8 weeks, 16 weeks
Change in TSS-IOP (Treatment Satisfaction Survey for IntraOcular Pressure)
Time frame: 8 weeks, 16 weeks
Results and safety
The study was stopped early (reason given: Problem with IP supply). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
Related trials for Primary Open Angle Glaucoma
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
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.
Marie-Josée Fredette, MD, FRCSC principal investigator
Centre de recherche du CHU de Québec; Université Laval
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 Generic latanoprost and Brand-name latanoprost in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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 5 inclusion and 22 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: stopped early, as of the sponsor's last update on 25 Jul 2017. 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 Canada. 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 was stopped early (reason given: Problem with IP supply). Results are not available in the source record.
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 Intraocular Pressure (IOP) (time frame: 8 weeks, 16 weeks). 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 25 Jul 2017.