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

Sponsor

Dr. David Yan (Other)

Overall Status

Unknown status

CT.gov ID

NCT02792803

Collaborator

Allergan (Industry)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

Anticipated 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 :

Sep 1, 2015

Actual Primary Completion Date :

Apr 1, 2017

Anticipated Study Completion Date :

Sep 1, 2017

Arms and Interventions

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 Names: 02296527 Drug: Co-Latanoprost A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma. Other Names: 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 Names: 02296527 Drug: Co-Latanoprost A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma. Other Names: 02254786

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