Efficacy and Safety of Three Different Latanoprost 0,005% Eyedrops in Subjects Affected by Primary Open Angle Glaucoma
Information source: University of Cantanzaro
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intraocular Pressure (IOP); Tear Break-Up Time
Intervention: IOPIZE© Latanoprost eyedrops (Drug); GALAXIA© Latanoprost eyedrops (Drug); Latanoprost RATIOPHARM© latanoprost eyedrops (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Cantanzaro Official(s) and/or principal investigator(s): Luigi Varano, M. D., Principal Investigator, Affiliation: University of Catanzaro
Overall contact: Luigi Varano, M. D., Phone: +3909613647365, Email: luigi-varano@libero.it
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: intraocular pressure (IOP) in mmHg
Secondary outcome: Tear Break-Up Time (BUT) expressed in seconds
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Luigi Varano, M. D., Phone: +3909613647365, Email: luigi-varano@libero.it
University of Catanzaro - Eye Department, Catanzaro 88100, Italy; Recruiting Luigi Varano, M.D., Phone: +3909613647365, Email: luigi-varano@libero.it Giovanni Scorcia, M. D., Phone: +3909613647135, Email: scorcia@unicz.it Luigi Varano, M. D., Principal Investigator Valentina De Luca, Sub-Investigator
Additional Information
Starting date: June 2011
Last updated: April 17, 2012
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