NCT02047630

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2014

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

January 19, 2014

Last Update Submit

July 23, 2017

Conditions

Primary Open Angle GlaucomaOcular Hypertension

Keywords

Primary open angle glaucomaOcular hypertensionlatanoprostgenericintraocular pressure

Outcome Measures

Primary Outcomes (1)

  • Change in Intraocular Pressure (IOP)

    Goldman applanation tonometry will be used to measure IOP.

    8 weeks, 16 weeks

Secondary Outcomes (3)

  • Change in Conjunctival hyperemia

    8 weeks, 16 weeks

  • Change in corneal staining

    8 weeks, 16 weeks

  • Change in TSS-IOP (Treatment Satisfaction Survey for IntraOcular Pressure)

    8 weeks, 16 weeks

Study Arms (2)

Generic latanoprost

EXPERIMENTAL

1 eye drop hs

Drug: Generic latanoprostDrug: Brand-name latanoprost

Brand-name latanoprost

ACTIVE COMPARATOR

1 eye drop hs

Drug: Generic latanoprostDrug: Brand-name latanoprost

Interventions

Generic latanoprostDRUG
Brand-name latanoprostGeneric latanoprost
Brand-name latanoprostDRUG
Also known as: Xalatan
Brand-name latanoprostGeneric latanoprost

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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)

You may not qualify if:

  • 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)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec

Québec, G1S 4L8, Canada

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Marie-Josée Fredette, MD, FRCSC

    Centre de recherche du CHU de Québec; Université Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FRCSC

Study Record Dates

First Submitted

January 19, 2014

First Posted

January 28, 2014

Study Start

January 1, 2014

Primary Completion

December 4, 2014

Study Completion

December 4, 2014

Last Updated

July 25, 2017

Record last verified: 2017-07

Locations

CA(1)