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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

Page last updated: August 23, 2015

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