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A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma

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ClinicalTrials.gov Identifier: NCT02792803
Recruitment Status : Recruiting
First Posted : June 8, 2016
Last Update Posted : July 26, 2017
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Dr. David Yan, DBYAN Medicine Professional Corporation

Brief 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. The study will also aim to prove the tolerability of Xalatan in terms of ocular hyperemia will be equivalent to its generic counterparts.

Condition or disease Intervention/treatment Phase
POAG Primary Open Angle Glaucoma Ocular Hypertension Drug: Xalatan Drug: Apo-Latanoprost Drug: Co-Latanoprost Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: An 8 Week Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Open Angle Glaucoma
Study Start Date : September 2015
Actual Primary Completion Date : April 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

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)
Drug: Xalatan
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
Other Names:
  • 02231493
  • Latanoprost

Drug: Apo-Latanoprost
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
Other Name: 02296527

Drug: Co-Latanoprost
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
Other Name: 02254786

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)
Drug: Xalatan
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
Other Names:
  • 02231493
  • Latanoprost

Drug: Apo-Latanoprost
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
Other Name: 02296527

Drug: Co-Latanoprost
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
Other Name: 02254786




Primary Outcome Measures :
  1. Intraocular Pressure [ Time Frame: 4 weeks ]
    Pressure within the eye will be measured at each study visit.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792803


Contacts
Contact: Jonathan Elin-Calcador 4165869626 jonathanec.ods@gmail.com

Locations
Canada, Ontario
Opthalmis Diagnostic Services Recruiting
Toronto, Ontario, Canada, M5G1Z5
Contact: Jonathan Elin-Calcador    4165869626    jonathanec.ods@gmail.com   
Principal Investigator: David B Yan, M.D., F.R.C.S. (C)         
Sponsors and Collaborators
Dr. David Yan
Allergan
Investigators
Principal Investigator: David B Yan, M.D., F.R.C.S. (C) Ophthalmic Diagnostic Services

Responsible Party: Dr. David Yan, M.D., F.R.C.S. (C), DBYAN Medicine Professional Corporation
ClinicalTrials.gov Identifier: NCT02792803     History of Changes
Other Study ID Numbers: Pro00012759
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dr. David Yan, DBYAN Medicine Professional Corporation:
POAG
Primary open angle glaucoma
Ocular Hypertension
Xalatan
Latanoprost
Ocular Hyperemia
IOP
Intraocular Pressure
Allergan
prostaglandin

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Antihypertensive Agents