Back to resultsEfficacy of the Brand-name Latanoprost and One of Its Generic Version in Primary Open Angle Glaucoma and Ocular Hypertension
Primary Purpose
Primary Open Angle Glaucoma, Ocular Hypertension
Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Generic latanoprost
Brand-name latanoprost
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Primary open angle glaucoma, Ocular hypertension, latanoprost, generic, intraocular pressure
Eligibility Criteria
Inclusion Criteria:
- >18 years old
- Primary open angle glaucoma, glaucoma suspect or ocular hypertension
- Bilateral
- Without any treatment or treated with latanoprost or another prostaglandin analog
- Intraocular pressure >21mmHg (without treatment or after a washout period)
Exclusion Criteria:
- Intraocular pressure >30mmHg
- Secondary glaucoma (uveitic, neovascular, traumatic ) or congenital glaucoma
- Pseudoexfoliation syndrome
- Pigmentary dispersion syndrome or Pigmentary glaucoma
- Severe glaucoma; Cup-to-disc ratio ≥9/10 OU Loss of central visual field (central 10°)
- Use of other topical medication to lower intraocular pressure
- Pregnancy and breast-feeding
- Being allergic to latanoprost or benzalkonium chloride (BAK)
- Current use of acetazolamide (Diamox)
- Changes of systemic doses of beta-blockers during study
- Recent use of topical corticosteroids (<1 month)
- Contact lens wearer
- Closed angle at gonioscopy or past angle closure glaucoma
- Filtration surgery (example. : trabeculectomy)
- Selective Laser Trabeculoplasty (SLT) or Argon Laser Trabeculoplasty(ALT)
- Recent Intraocular surgery (<3 months)
- Refractive surgery
- Recent iridotomy or capsulotomy (<3 months)
- Past medical history of ocular trauma (example : angle recession)
- Past or active uveitis
- Herpetic keratitis
- Monocular vision
Sites / Locations
- Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Generic latanoprost
Brand-name latanoprost
Arm Description
1 eye drop hs
1 eye drop hs
Outcomes
Primary Outcome Measures
Change in Intraocular Pressure (IOP)
Goldman applanation tonometry will be used to measure IOP.
Secondary Outcome Measures
Change in Conjunctival hyperemia
Change in corneal staining
Oxford grading scale
Change in TSS-IOP (Treatment Satisfaction Survey for IntraOcular Pressure)
Full Information
NCT ID
NCT02047630
First Posted
January 19, 2014
Last Updated
July 23, 2017
Sponsor
CHU de Quebec-Universite Laval
1. Study Identification
Unique Protocol Identification Number
NCT02047630
Brief Title
Efficacy of the Brand-name Latanoprost and One of Its Generic Version in Primary Open Angle Glaucoma and Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Problem with IP supply
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 4, 2014 (Actual)
Study Completion Date
December 4, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHU de Quebec-Universite Laval
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate and compare efficacy and tolerability of the brand-name latanoprost and one of its generic version in subjects with primary open angle glaucoma or ocular hypertension.
This randomized, double-blinded, cross-over design study has a 4 months follow-up. There are two periods of 8 weeks. During the first period, subjects put brand-name latanoprost in one eye and the generic version in the other one. In the second period, drops are switched from one eye to the other. There are intraocular pressure measurements (diurnal curves) on day 0 (before treatment), at 8 weeks (at the end of first period) and at 16 weeks (at the end of second period). Variations of intraocular pressure in each eye will be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Ocular Hypertension
Keywords
Primary open angle glaucoma, Ocular hypertension, latanoprost, generic, intraocular pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Generic latanoprost
Arm Type
Experimental
Arm Description
1 eye drop hs
Arm Title
Brand-name latanoprost
Arm Type
Active Comparator
Arm Description
1 eye drop hs
Intervention Type
Drug
Intervention Name(s)
Generic latanoprost
Intervention Type
Drug
Intervention Name(s)
Brand-name latanoprost
Other Intervention Name(s)
Xalatan
Primary Outcome Measure Information:
Title
Change in Intraocular Pressure (IOP)
Description
Goldman applanation tonometry will be used to measure IOP.
Time Frame
8 weeks, 16 weeks
Secondary Outcome Measure Information:
Title
Change in Conjunctival hyperemia
Time Frame
8 weeks, 16 weeks
Title
Change in corneal staining
Description
Oxford grading scale
Time Frame
8 weeks, 16 weeks
Title
Change in TSS-IOP (Treatment Satisfaction Survey for IntraOcular Pressure)
Time Frame
8 weeks, 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>18 years old
Primary open angle glaucoma, glaucoma suspect or ocular hypertension
Bilateral
Without any treatment or treated with latanoprost or another prostaglandin analog
Intraocular pressure >21mmHg (without treatment or after a washout period)
Exclusion Criteria:
Intraocular pressure >30mmHg
Secondary glaucoma (uveitic, neovascular, traumatic ) or congenital glaucoma
Pseudoexfoliation syndrome
Pigmentary dispersion syndrome or Pigmentary glaucoma
Severe glaucoma; Cup-to-disc ratio ≥9/10 OU Loss of central visual field (central 10°)
Use of other topical medication to lower intraocular pressure
Pregnancy and breast-feeding
Being allergic to latanoprost or benzalkonium chloride (BAK)
Current use of acetazolamide (Diamox)
Changes of systemic doses of beta-blockers during study
Recent use of topical corticosteroids (<1 month)
Contact lens wearer
Closed angle at gonioscopy or past angle closure glaucoma
Filtration surgery (example. : trabeculectomy)
Selective Laser Trabeculoplasty (SLT) or Argon Laser Trabeculoplasty(ALT)
Recent Intraocular surgery (<3 months)
Refractive surgery
Recent iridotomy or capsulotomy (<3 months)
Past medical history of ocular trauma (example : angle recession)
Past or active uveitis
Herpetic keratitis
Monocular vision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Josée Fredette, MD, FRCSC
Organizational Affiliation
Centre de recherche du CHU de Québec; Université Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
City
Québec
ZIP/Postal Code
G1S 4L8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Efficacy of the Brand-name Latanoprost and One of Its Generic Version in Primary Open Angle Glaucoma and Ocular Hypertension
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