POAGPhase 4NCT02792803
A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma
A Phase 4 study testing Xalatan, Apo-Latanoprost and Co-Latanoprost in people with POAG and Primary Open Angle Glaucoma, run by Dr. David Yan at 1 site in Canada.
Trial summary
The purpose of the study is to provide evidence that the efficacy of Xalatan will be superior to Apo-latanoprost and Co-latanoprost in the reduction of intraocular pressure in patients with primary open angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- POAG, Primary Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Xalatan, Apo-Latanoprost and Co-Latanoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Sep 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years old, diagnosed with primary open angle glaucoma or ocular hypertension
- IOP currently controlled on prostaglandin analogue monotherapy (latanoprost, bimatoprost or travoprost), as judged by the investigator
Who cannot join
- Best corrected visual acuity worse than 0.6 logMAR or 20/80 Snellen in either eye.
- Patients in whom the mean IOP in either eye at the screening exam visit is greater than 36 mmHg
- History of ocular trauma within the past six (6) months.
- History of ocular infection or ocular inflammation within the past three (3) months.
- History of chronic or recurrent severe inflammatory eye disease (i.e., scleritis, uveitis)
- History of severe or serious hypersensitivity to any components of the study medications.
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- Any abnormality preventing reliable applanation tonometry of either eye.
- Intraocular surgery within the past six (6) months as determined by patient history and/or examination.
- Patients with cup/disc ratio greater than 0.80 in either eye.
- Patients with severe central visual field loss in either eye defined as a sensitivity less than or equal to 10 dB in at least two (2) of the four (4) visual field test points closest to the point of fixation. Visual field test must be within 6 months of eligibility assessment.
- History of clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment.
- Current use of ANY glucocorticoid administered by any route. Patient must have washed out of the glucocorticoid for at least 4 weeks prior to study entry.
- Use of any systemic prostaglandin or prostaglandin analogue within the last three months.
- Current use of topical non-steroidal antiinflammatory agents which inhibit cyclo-oxygenase and prostaglandin analogue synthesis.
- Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component).
- Current use of topical non-steroidal anti inflammatory agents which inhibit cyclo-oxygenase and prostaglandin analogue synthesis.
- Angle grade less than 2 (extreme narrow angle with complete or partial closure) as measured by gonioscopy.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Opthalmis Diagnostic Services
Toronto, Ontario, M5G1Z5
Jonathan Elin-Calcador, 4165869626, jonathanec.ods@gmail.com
David B Yan, M.D., F.R.C.S. (C)
About this study
Official title: An 8 Week Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Open Angle Glaucoma
The purpose of the study is to provide evidence that the efficacy of Xalatan will be superior to Apo-latanoprost and Co-latanoprost in the reduction of intraocular pressure in patients with primary open angle glaucoma. The study will also aim to prove the tolerability of Xalatan in terms of ocular hyperemia will be equivalent to its generic counterparts.
Read the detailed description
Since the introduction of Xalatan generic versions of latanoprost have entered the Canadian marketplace such as Apo-latanoprost (Apotex Inc.), Co-latanoprost (Cobalt Pharmaceuticals Co.) and Sandoz latanoprost (Sandoz Canada Inc.). The exact formulation of the different preparations of latanoprost may differ between manufacturers, although the active ingredient itself is not supposed to vary within a 15% tolerance. In a topical ocular medication in a multi-dose dispenser, the stability of the drug and its ability to penetrate the cornea into the eye may affect the efficacy of the drug.
There are no clinical trials to compare the efficacy of generic versions of latanoprost to Xalatan, nor are there any clinical trials comparing efficacy between the different generic versions. Empirical evidence based on clinical experience suggests that at least some of the generic versions of latanoprost may not be as effective as the branded version (Xalatan). Intraocular pressure is often observed to increase when switching from a branded to generic version of latanoprost, but the opposite is rarely if ever observed. The purpose of this study will be to compare the efficacy of Xalatan to two of the most popular generic versions of latanoprost available in Canada (Apo-latanoprost and Co-latanoprost).
- Conditions
- POAG, Primary Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Xalatan, Apo-Latanoprost, Co-Latanoprost
- Keywords
- POAG, Primary open angle glaucoma, Ocular Hypertension, Xalatan, Latanoprost, Ocular Hyperemia, IOP, Intraocular Pressure, Allergan, prostaglandin
- 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.
XalatanDrug
Also called 02231493, Latanoprost
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
Apo-LatanoprostDrug
Also called 02296527
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
Co-LatanoprostDrug
Also called 02254786
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
| Study group | Role | What they receive |
|---|---|---|
| Xalatan --> Apo-/Co-Latanoprost | Experimental | Patients in this arm will be prescribed Xalatan for the first four week period of the study and one of the generics, Apo- or Co-Latanoprost, for the second four week period. Patients will take one drop of the assigned drops in the affected eye every evening at 2100 hrs (+- 1 hr) Receives: Drug: Xalatan; Drug: Apo-Latanoprost; Drug: Co-Latanoprost |
| Apo-/Co-Latanoprost --> Xalatan | Experimental | Patients in this arm will be prescribed one of the generics, Apo- or Co-Latanoprost, for the first four week period of the study and Xalatan for the second four week period. Patients will take one drop of the assigned drops in the affected eye every evening at 2100 hrs (+- 1 hr) Receives: Drug: Xalatan; Drug: Apo-Latanoprost; Drug: Co-Latanoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure
Pressure within the eye will be measured at each study visit.
Measured: 4 weeks
Secondary outcomes (1)
Ocular Hyperemia
Redness of the cornea will be quantified at each study visit using the Efron scale. The scale reads 0-5, 5 being the highest level of ocular hyperemia.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startSep 2015
- Primary completionApr 2017
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for POAGStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. David Yan
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor-investigator, Dr. David Yan, DBYAN Medicine Professional Corporation
- Investigators
- David B Yan, M.D., F.R.C.S. (C), Principal investigator, Ophthalmic Diagnostic Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792803
- Sponsor's protocol ID
- Pro00012759
- Status last verified
- Jul 2017
- First submitted
- 31 May 2016
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8 Week Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT02792803
- Acronym / sponsor ID
- Pro00012759
- Conditions
- POAG, Primary Open Angle Glaucoma, Ocular Hypertension
- Keywords
- POAG, Primary open angle glaucoma, Ocular Hypertension, Xalatan, Latanoprost, Ocular Hyperemia, IOP, Intraocular Pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr. David YanUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Sep 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Sep 2017 (estimated)
- First posted
- 8 Jun 2016 (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 the study is to provide evidence that the efficacy of Xalatan will be superior to Apo-latanoprost and Co-latanoprost in the reduction of intraocular pressure in patients with primary open angle glaucoma. The study will also aim to prove the tolerability of Xalatan in terms of ocular hyperemia will be equivalent to its generic counterparts.
Detailed description
Since the introduction of Xalatan generic versions of latanoprost have entered the Canadian marketplace such as Apo-latanoprost (Apotex Inc.), Co-latanoprost (Cobalt Pharmaceuticals Co.) and Sandoz latanoprost (Sandoz Canada Inc.). The exact formulation of the different preparations of latanoprost may differ between manufacturers, although the active ingredient itself is not supposed to vary within a 15% tolerance. In a topical ocular medication in a multi-dose dispenser, the stability of the drug and its ability to penetrate the cornea into the eye may affect the efficacy of the drug.
There are no clinical trials to compare the efficacy of generic versions of latanoprost to Xalatan, nor are there any clinical trials comparing efficacy between the different generic versions. Empirical evidence based on clinical experience suggests that at least some of the generic versions of latanoprost may not be as effective as the branded version (Xalatan). Intraocular pressure is often observed to increase when switching from a branded to generic version of latanoprost, but the opposite is rarely if ever observed. The purpose of this study will be to compare the efficacy of Xalatan to two of the most popular generic versions of latanoprost available in Canada (Apo-latanoprost and Co-latanoprost).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xalatan --> Apo-/Co-Latanoprost | Experimental | Drug: Xalatan, Drug: Apo-Latanoprost, Drug: Co-LatanoprostPatients in this arm will be prescribed Xalatan for the first four week period of the study and one of the generics, Apo- or Co-Latanoprost, for the second four week period. Patients will take one drop of the assigned drops in the affected eye every evening at 2100 hrs (+- 1 hr) |
| Apo-/Co-Latanoprost --> Xalatan | Experimental | Drug: Xalatan, Drug: Apo-Latanoprost, Drug: Co-LatanoprostPatients in this arm will be prescribed one of the generics, Apo- or Co-Latanoprost, for the first four week period of the study and Xalatan for the second four week period. Patients will take one drop of the assigned drops in the affected eye every evening at 2100 hrs (+- 1 hr) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≥ 18 years old, diagnosed with primary open angle glaucoma or ocular hypertension
- IOP currently controlled on prostaglandin analogue monotherapy (latanoprost, bimatoprost or travoprost), as judged by the investigator
Key exclusion criteria (17 listed)
- Best corrected visual acuity worse than 0.6 logMAR or 20/80 Snellen in either eye.
- Patients in whom the mean IOP in either eye at the screening exam visit is greater than 36 mmHg
- History of ocular trauma within the past six (6) months.
- History of ocular infection or ocular inflammation within the past three (3) months.
- History of chronic or recurrent severe inflammatory eye disease (i.e., scleritis, uveitis)
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 |
|---|---|---|
| XalatanAlso: 02231493, LatanoprostA prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma. | Drug | Apo-/Co-Latanoprost --> Xalatan, Xalatan --> Apo-/Co-Latanoprost |
| Apo-LatanoprostAlso: 02296527A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma. | Drug | Apo-/Co-Latanoprost --> Xalatan, Xalatan --> Apo-/Co-Latanoprost |
| Co-LatanoprostAlso: 02254786A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma. | Drug | Apo-/Co-Latanoprost --> Xalatan, Xalatan --> Apo-/Co-Latanoprost |
Primary outcome
Intraocular Pressure
Time frame: 4 weeks
Pressure within the eye will be measured at each study visit.
1 secondary outcome
Ocular Hyperemia
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
David B Yan, M.D., F.R.C.S. (C) principal investigator
Ophthalmic Diagnostic Services
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 Xalatan, Apo-Latanoprost and Co-Latanoprost in people with POAG and Primary Open Angle Glaucoma, run by Dr. David Yan 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 2 inclusion and 17 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 26 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Elin-Calcador (4165869626, jonathanec.ods@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure (time frame: 4 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 26 Jul 2017.