- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02792803
A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma
An 8 Week Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Open Angle Glaucoma
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Jonathan Elin-Calcador
- Phone Number: 4165869626
- Email: jonathanec.ods@gmail.com
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G1Z5
- Recruiting
- Opthalmis Diagnostic Services
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Contact:
- Jonathan Elin-Calcador
- Phone Number: 4165869626
- Email: jonathanec.ods@gmail.com
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Principal Investigator:
- David B Yan, M.D., F.R.C.S. (C)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Xalatan --> Apo-/Co-Latanoprost
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)
|
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
Other Names:
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
Other Names:
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
Other Names:
|
Experimental: Apo-/Co-Latanoprost --> Xalatan
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)
|
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
Other Names:
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
Other Names:
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraocular Pressure
Time Frame: 4 weeks
|
Pressure within the eye will be measured at each study visit.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ocular Hyperemia
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David B Yan, M.D., F.R.C.S. (C), Ophthalmic Diagnostic Services
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00012759
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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