Text Size

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

This study is currently recruiting participants.
Verified April 2012 by University of Cantanzaro
Sponsor:
Information provided by (Responsible Party):
Luigi Varano, MD - Principal Investigator, University of Cantanzaro
ClinicalTrials.gov Identifier:
NCT01580254
First received: April 17, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Intraocular Pressure (IOP)
Tear Break-Up Time
 Drug: IOPIZE© Latanoprost eyedrops
Drug: GALAXIA© Latanoprost eyedrops
Drug: Latanoprost RATIOPHARM© latanoprost eyedrops
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by University of Cantanzaro:

Primary Outcome Measures:
  • intraocular pressure (IOP) in mmHg [ Time Frame: one month - two months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: one month - two months ] [ Designated as safety issue: Yes ]
    After one and two months of therapy with latanoprost, tear BUT will be calculated, through the use of fluoresceine staining of the tear film.


Estimated Enrollment: 120
Study Start Date: June 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Latanoprost RATIOPHARM© eyedrops (RATIOPHARM GmbH - Ulm, Germany)
  • authorization number:
  • 039468018/M

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580254

Contacts
Contact: Luigi Varano, M. D. +3909613647365 luigi-varano@libero.it
Contact: Giovanni Scorcia, M. D. +39 09613647135 scorcia@unicz.it

Locations
Italy
University of Catanzaro - Eye Department Recruiting
Catanzaro, Italy, 88100
Contact: Luigi Varano, M.D.     +3909613647365     luigi-varano@libero.it    
Contact: Giovanni Scorcia, M. D.     +3909613647135     scorcia@unicz.it    
Principal Investigator: Luigi Varano, M. D.            
Sub-Investigator: Valentina De Luca            
Sponsors and Collaborators
University of Cantanzaro
Investigators
Principal Investigator: Luigi Varano, M. D. University of Catanzaro
  More Information

No publications provided

Responsible Party: Luigi Varano, MD - Principal Investigator, M. D., University of Cantanzaro
ClinicalTrials.gov Identifier: NCT01580254     History of Changes
Other Study ID Numbers: GENERIC-LATANOPROST
Study First Received: April 17, 2012
Last Updated: April 17, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Cantanzaro:
Latanoprost
IOP

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Tetrahydrozoline
Latanoprost
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 23, 2013