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Status unknownNCT02792803Updated Jul 26, 2017

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

A Phase 4 interventional study of Xalatan and Apo-Latanoprost in POAG, Primary Open Angle Glaucoma and Ocular Hypertension, sponsored by Dr. David Yan. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-26.

Sponsored by Dr. David Yan · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • POAG
  • Primary Open Angle Glaucoma
  • Ocular Hypertension

Keywords

  • POAG
  • Primary open angle glaucoma
  • Ocular Hypertension
  • Xalatan
  • Latanoprost
  • Ocular Hyperemia
  • IOP
  • Intraocular Pressure
  • Allergan
  • prostaglandin
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's planned enrollment of 60 is close to the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

This is the only study on the registry with Dr. David Yan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
60 participants (estimated)

Study arms

  • 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 · Drug: Apo-Latanoprost · Drug: Co-Latanoprost

  • 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 · Drug: Apo-Latanoprost · Drug: Co-Latanoprost

Interventions

  • DrugXalatan

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

    Also known as: 02231493, Latanoprost

  • DrugApo-Latanoprost

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

    Also known as: 02296527

  • DrugCo-Latanoprost

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

    Also known as: 02254786

06

What researchers measure

Primary outcomes

  1. Intraocular Pressure

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

    Time frame: 4 weeks

Secondary outcomes

  1. 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.

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Opthalmis Diagnostic Services
    Toronto, Ontario M5G1Z5, Canada
    • Jonathan Elin-Calcador · Contact · jonathanec.ods@gmail.com · 4165869626
    • David B Yan, M.D., F.R.C.S. (C) · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02792803
Lead sponsor
Dr. David Yan
Collaborators
Allergan
Responsible party
Dr. David Yan (M.D., F.R.C.S. (C), DBYAN Medicine Professional Corporation) — Sponsor-investigator
First posted
Jun 8, 2016
Start date
Sep 2015
Primary completion
Apr 2017
Completion
Sep 2017 (estimated)
Last update
Jul 26, 2017

Study contacts

Jonathan Elin-Calcador
Contact
jonathanec.ods@gmail.com
4165869626
David B Yan, M.D., F.R.C.S. (C)
principal investigator · Ophthalmic Diagnostic Services

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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