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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02792803
• Other study ID #: Pro00012759
• Status: Recruiting
• Phase: Phase 4
• First received: May 31, 2016
• Last updated: July 25, 2017
• Start date: September 2015
• Est. completion date: September 2017

Study information

• Verified date: July 2017
• Source: DBYAN Medicine Professional Corporation
• Contact: Jonathan Elin-Calcador
• Phone: 4165869626
• Email: jonathanec.ods[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• POAG
• Primary Open Angle Glaucoma

Intervention

Drug:
• Xalatan
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
• Apo-Latanoprost
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
• Co-Latanoprost
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.

Locations

Country	Name	City	State
Canada	Opthalmis Diagnostic Services	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Dr. David Yan	Allergan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure	Pressure within the eye will be measured at each study visit.	4 weeks
Secondary	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.	4 weeks