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

April 17, 2012 updated by: Luigi Varano, MD - Principal Investigator, University of Catanzaro

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catanzaro, Italy, 88100
        • Recruiting
        • University of Catanzaro - Eye Department
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luigi Varano, M. D.
        • Sub-Investigator:
          • Valentina De Luca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IOPIZE© eyedrops
subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is IOPIZE©
Drug: IOPIZE© Latanoprost eyedrops
patients will receive in each eligible eye one drop of IOPIZE© Latanoprost eyedrops once a day, in the evening (8pm), for two months
Other Names:
  • IOPIZE© eyedrops (S.I.F.I. S.p.A. - Aci S. Antonio (CT), Italy)
  • authorization numbers:
  • 039276011
  • 039276023
  • 039276035
Active Comparator: GALAXIA© eyedrops
subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is GALAXIA©
Drug: GALAXIA© Latanoprost eyedrops
patients will receive in each eligible eye one drop of GALAXIA© Latanoprost eyedrops once a day, in the evening (8pm), for two months
Other Names:
  • GALAXIA© eyedrops (ALFA INTES Industria Terapeutica Splendore S.r.l. - Casoria (NA), Italy)
  • authorization number:
  • 038622015
Active Comparator: Latanoprost RATIOPHARM© eyedrops
subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is Latanoprost RATIOPHARM©
Drug: Latanoprost RATIOPHARM© latanoprost eyedrops
patients will receive in each eligible eye one drop of Latanoprost RATIOPHARM© Latanoprost eyedrops once a day, in the evening (8pm), for two months
Other Names:
  • authorization number:
  • Latanoprost RATIOPHARM© eyedrops (RATIOPHARM GmbH - Ulm, Germany)
  • 039468018/M

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraocular pressure (IOP) in mmHg
Time Frame: one month - two months
to evaluate intraocular pressure (IOP) reduction after one and two months treatment with latanoprost eyedrops
one month - two months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catanzaro

Investigators

  • Principal Investigator: Luigi Varano, M. D., University of Catanzaro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

April 17, 2012

First Submitted That Met QC Criteria

April 17, 2012

First Posted (Estimate)

April 18, 2012

Study Record Updates

Last Update Posted (Estimate)

April 18, 2012

Last Update Submitted That Met QC Criteria

April 17, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GENERIC-LATANOPROST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intraocular Pressure (IOP)

Clinical Trials on IOPIZE© Latanoprost eyedrops

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe