Recruiting

Latanoprost vs. Apo-latanoprost

Sponsor:

Dr. David Yan

Code:

NCT02792803

Conditions

POAG

Primary Open Angle Glaucoma

Ocular Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Xalatan

Apo-Latanoprost

Co-Latanoprost

Study Details

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.

Conditions

POAG

Primary Open Angle Glaucoma

Ocular Hypertension

Study ID

NCT02792803

Start date

Sep, 2015

Status verified date

Jul, 2017

Completion date

Sep, 2017

Anticipated

Primary completion date

Apr, 2017

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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)

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)

Interventions

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.

Primary outcome measure

  • Intraocular Pressure [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Jonathan Elin-Calcador

4165869626jonathanec.ods@gmail.com

Locations

Opthalmis Diagnostic Services

Recruiting

Toronto, Ontario, Canada, M5G1Z5

Contacts

Jonathan Elin-Calcador

4165869626jonathanec.ods@gmail.com

Principal Investigator:

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

More Information

Sponsor

Dr. David Yan

Last update posted

Jul 26, 2017

Last verified

Jul, 2017

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dr. David Yan on 2017-07-26.