Clinical trial NCT01580254: Efficacy and Safety of Three Different Latanoprost 0,005% Eyedrops in Subjects Affected by Primary Open Angle Glaucoma
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Intraocular Pressure (IOP)
Tear Break-Up Time
Keywords: Latanoprost
IOP
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
First posted: 2012-04-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: intraocular pressure (IOP) in mmHg
timeFrame: one month - two months
Secondary outcomes:
measure: Tear Break-Up Time (BUT) expressed in seconds
timeFrame: one month - two months
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: University of Catanzaro - Eye Department
Study officials:
affiliation: University of Catanzaro
name: Luigi Varano, M. D.
role: PRINCIPAL_INVESTIGATOR
References: