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

NCT02792803 | Unknown Phase 4

• 1 other identifier: Pro00012759
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure

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

  4 weeks

Secondary Outcomes (1)

• Ocular Hyperemia

  4 weeks

Study Arms (2)

Xalatan --> Apo-/Co-Latanoprost

EXPERIMENTAL

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

Apo-/Co-Latanoprost --> Xalatan

EXPERIMENTAL

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

Xalatan DRUG

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

Also known as: 02231493, Latanoprost

Apo-/Co-Latanoprost --> Xalatan; Xalatan --> Apo-/Co-Latanoprost

Apo-Latanoprost DRUG

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

Also known as: 02296527

Apo-/Co-Latanoprost --> Xalatan; Xalatan --> Apo-/Co-Latanoprost

Co-Latanoprost DRUG

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

Also known as: 02254786

Apo-/Co-Latanoprost --> Xalatan; Xalatan --> Apo-/Co-Latanoprost

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dr. David Yan: lead
• Allergan: collaborator

Study Sites (1)

Opthalmis Diagnostic Services

Toronto, Ontario, M5G1Z5, Canada

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• David B Yan, M.D., F.R.C.S. (C)

  Ophthalmic Diagnostic Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Elin-Calcador

CONTACT

4165869626; jonathanec.ods@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., F.R.C.S. (C)

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 8, 2016
• Study Start: September 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: September 1, 2017
• Last Updated: July 26, 2017

Record last verified: 2017-07

Locations

CA (1)