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

Intraocular Pressure (IOP) Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01580254
• Other study ID #: GENERIC-LATANOPROST
• Status: Recruiting
• Phase: Phase 4
• First received: April 17, 2012
• Last updated: April 17, 2012
• Start date: June 2011
• Est. completion date: July 2012

Study information

• Verified date: April 2012
• Source: University of Cantanzaro
• Contact: Luigi Varano, M. D.
• Phone: +3909613647365
• Email: luigi-varano[@]libero.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Intraocular Pressure (IOP)
• Tear Break-Up Time

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Italy	University of Catanzaro - Eye Department	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University of Cantanzaro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraocular pressure (IOP) in mmHg	to evaluate intraocular pressure (IOP) reduction after one and two months treatment with latanoprost eyedrops	one month - two months	Yes
Secondary	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.	one month - two months	Yes