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Efficacy and Safety of Three Different Latanoprost 0,005% Eyedrops in Subjects Affected by Primary Open Angle Glaucoma (LATANOPROST)

Primary Purpose

Intraocular Pressure (IOP), Tear Break-Up Time

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
IOPIZE© Latanoprost eyedrops
GALAXIA© Latanoprost eyedrops
Latanoprost RATIOPHARM© latanoprost eyedrops
Sponsored by
University of Catanzaro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraocular Pressure (IOP) focused on measuring Latanoprost, IOP

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ranged between 18 and 80
  • Untreated IOP ranged between 21 and 30 mmHg
  • IOP already treated with a single drug (monotherapy) ranged between 10 and 28 mmHg

Exclusion Criteria:

  • History of adverse events or any controindication to drugs administred during sperimentation, i. e. Latanoprost and Timolol.
  • Narrow or closed iridocorneal angle.
  • History of acute angle-closure glaucoma.
  • Previous laser trabeculoplasty within 3 months before screening.
  • Severe visual field defects within 10° from fixation in at least one eye (at least 2 points with a p<0,5 in a pattern deviation map obtained from a reliable 24-2 Sita Standard SAP).
  • History of refractive surgery or any keratoplasty procedure, corneal opacities or diseases that make not suitable applanation tonometry.
  • Use of contact lenses.
  • BCVA less than 20/200.
  • Ocular inflammation/infection occurring within three months before screening.
  • History of bradicardia, systemic hypotension, bundle branch or any atrio-ventricular block
  • Asthma
  • Women of childbearing potential who were not using adequate contraceptive methods or who were pregnant or nursing

Sites / Locations

  • University of Catanzaro - Eye DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

IOPIZE© eyedrops

GALAXIA© eyedrops

Latanoprost RATIOPHARM© eyedrops

Arm Description

subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is IOPIZE©

subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is GALAXIA©

subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is Latanoprost RATIOPHARM©

Outcomes

Primary Outcome Measures

intraocular pressure (IOP) in mmHg
to evaluate intraocular pressure (IOP) reduction after one and two months treatment with latanoprost eyedrops

Secondary Outcome Measures

Tear Break-Up Time (BUT) expressed in seconds
After one and two months of therapy with latanoprost, tear BUT will be calculated, through the use of fluoresceine staining of the tear film.

Full Information

First Posted
April 17, 2012
Last Updated
April 17, 2012
Sponsor
University of Catanzaro
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1. Study Identification

Unique Protocol Identification Number
NCT01580254
Brief Title
Efficacy and Safety of Three Different Latanoprost 0,005% Eyedrops in Subjects Affected by Primary Open Angle Glaucoma
Acronym
LATANOPROST
Official Title
Phase 4 Study to Evaluate Efficacy And Safety of Three Different Preparations of Latanoprost 0,005% Eyedrops in Subjects Affected by Primary Open Angle Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catanzaro

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study examines efficacy and tolerability of 3 different Latanoprost 0.005% eyedrops preparations, commercially available in Italy, in subjects affected by primary open angle glaucoma.
Detailed Description
Prospective, randomized, single blinded study of the duration of 3 months, involving subjects affected by POAG or OH under therapy with different Latanoprost drugs (Galaxia, Iopize or Latanoprost Rathiopharm). A total of 120 patients affected by POAG or OH newly diagnosed or already under topical therapy. will be recruited. After a recruitment visit to assest eligibility of each subject, a "run-in" therapy composed of timolol 0,5% 2 drops per day will be prescribed for 4 weeks. Then a baseline visit will be performed to evaluate IOP values and adverse effects in each subject. All subjects elegible for a therapy with a single dose of Latanoprost will be randomized into 3 arms. After 4 weeks of therapy a second visit will be made to assest IOP changes and safety. Therapy will be continued for another 4 weeks, and after that, a final visit will be made.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Pressure (IOP), Tear Break-Up Time
Keywords
Latanoprost, IOP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IOPIZE© eyedrops
Arm Type
Active Comparator
Arm Description
subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is IOPIZE©
Arm Title
GALAXIA© eyedrops
Arm Type
Active Comparator
Arm Description
subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is GALAXIA©
Arm Title
Latanoprost RATIOPHARM© eyedrops
Arm Type
Active Comparator
Arm Description
subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is Latanoprost RATIOPHARM©
Intervention Type
Drug
Intervention Name(s)
IOPIZE© Latanoprost eyedrops
Other Intervention Name(s)
IOPIZE© eyedrops (S.I.F.I. S.p.A. - Aci S. Antonio (CT), Italy), authorization numbers:, 039276011, 039276023, 039276035
Intervention Description
patients will receive in each eligible eye one drop of IOPIZE© Latanoprost eyedrops once a day, in the evening (8pm), for two months
Intervention Type
Drug
Intervention Name(s)
GALAXIA© Latanoprost eyedrops
Other Intervention Name(s)
GALAXIA© eyedrops (ALFA INTES Industria Terapeutica Splendore S.r.l. - Casoria (NA), Italy), authorization number:, 038622015
Intervention Description
patients will receive in each eligible eye one drop of GALAXIA© Latanoprost eyedrops once a day, in the evening (8pm), for two months
Intervention Type
Drug
Intervention Name(s)
Latanoprost RATIOPHARM© latanoprost eyedrops
Other Intervention Name(s)
Latanoprost RATIOPHARM© eyedrops (RATIOPHARM GmbH - Ulm, Germany), authorization number:, 039468018/M
Intervention Description
patients will receive in each eligible eye one drop of Latanoprost RATIOPHARM© Latanoprost eyedrops once a day, in the evening (8pm), for two months
Primary Outcome Measure Information:
Title
intraocular pressure (IOP) in mmHg
Description
to evaluate intraocular pressure (IOP) reduction after one and two months treatment with latanoprost eyedrops
Time Frame
one month - two months
Secondary Outcome Measure Information:
Title
Tear Break-Up Time (BUT) expressed in seconds
Description
After one and two months of therapy with latanoprost, tear BUT will be calculated, through the use of fluoresceine staining of the tear film.
Time Frame
one month - two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ranged between 18 and 80 Untreated IOP ranged between 21 and 30 mmHg IOP already treated with a single drug (monotherapy) ranged between 10 and 28 mmHg Exclusion Criteria: History of adverse events or any controindication to drugs administred during sperimentation, i. e. Latanoprost and Timolol. Narrow or closed iridocorneal angle. History of acute angle-closure glaucoma. Previous laser trabeculoplasty within 3 months before screening. Severe visual field defects within 10° from fixation in at least one eye (at least 2 points with a p<0,5 in a pattern deviation map obtained from a reliable 24-2 Sita Standard SAP). History of refractive surgery or any keratoplasty procedure, corneal opacities or diseases that make not suitable applanation tonometry. Use of contact lenses. BCVA less than 20/200. Ocular inflammation/infection occurring within three months before screening. History of bradicardia, systemic hypotension, bundle branch or any atrio-ventricular block Asthma Women of childbearing potential who were not using adequate contraceptive methods or who were pregnant or nursing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luigi Varano, M. D.
Phone
+3909613647365
Email
luigi-varano@libero.it
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanni Scorcia, M. D.
Phone
+39 09613647135
Email
scorcia@unicz.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Varano, M. D.
Organizational Affiliation
University of Catanzaro
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Catanzaro - Eye Department
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Varano, M.D.
Phone
+3909613647365
Email
luigi-varano@libero.it
First Name & Middle Initial & Last Name & Degree
Giovanni Scorcia, M. D.
Phone
+3909613647135
Email
scorcia@unicz.it
First Name & Middle Initial & Last Name & Degree
Luigi Varano, M. D.
First Name & Middle Initial & Last Name & Degree
Valentina De Luca

12. IPD Sharing Statement

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Efficacy and Safety of Three Different Latanoprost 0,005% Eyedrops in Subjects Affected by Primary Open Angle Glaucoma

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