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

Primary Purpose

POAG, Primary Open Angle Glaucoma, Ocular Hypertension

Status

Unknown status

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Xalatan

Apo-Latanoprost

Co-Latanoprost

About this trial

This is an interventional treatment trial for POAG focused on measuring POAG, Primary open angle glaucoma, Ocular Hypertension, Xalatan, Latanoprost, Ocular Hyperemia, IOP, Intraocular Pressure, Allergan, prostaglandin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Opthalmis Diagnostic ServicesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Xalatan --> Apo-/Co-Latanoprost

Apo-/Co-Latanoprost --> Xalatan

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Intraocular Pressure

Pressure within the eye will be measured at each study visit.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02792803

First Posted

May 31, 2016

Last Updated

July 25, 2017

Sponsor

Dr. David Yan

Collaborators

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT02792803

Brief Title

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

Official Title

An 8 Week Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Open Angle Glaucoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr. David Yan

Collaborators

Allergan

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

POAG, Primary Open Angle Glaucoma, Ocular Hypertension

Keywords

POAG, Primary open angle glaucoma, Ocular Hypertension, Xalatan, Latanoprost, Ocular Hyperemia, IOP, Intraocular Pressure, Allergan, prostaglandin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Xalatan --> Apo-/Co-Latanoprost

Arm Type

Experimental

Arm Description

Arm Title

Apo-/Co-Latanoprost --> Xalatan

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Xalatan

Other Intervention Name(s)

02231493, Latanoprost

Intervention Description

A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.

Intervention Type

Drug

Intervention Name(s)

Apo-Latanoprost

Other Intervention Name(s)

02296527

Intervention Description

A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.

Intervention Type

Drug

Intervention Name(s)

Co-Latanoprost

Other Intervention Name(s)

02254786

Intervention Description

A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.

Primary Outcome Measure Information:

Title

Intraocular Pressure

Description

Pressure within the eye will be measured at each study visit.

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Ocular Hyperemia

Description

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.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jonathan Elin-Calcador

Phone

4165869626

jonathanec.ods@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David B Yan, M.D., F.R.C.S. (C)

Organizational Affiliation

Ophthalmic Diagnostic Services

Official's Role

Principal Investigator

Facility Information:

Facility Name

Opthalmis Diagnostic Services

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G1Z5

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jonathan Elin-Calcador

Phone

4165869626

jonathanec.ods@gmail.com

First Name & Middle Initial & Last Name & Degree

David B Yan, M.D., F.R.C.S. (C)

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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