Safety, Efficacy Assessment of Geltim LP® 1 mg/g in Ocular Hypertensive or Glaucomatous Patients. (T1030)

This study has been completed.

Sponsor:

Collaborators:

AXONAL

CSD Medical Research

VEEDA

Information provided by:

Laboratoires Thea

ClinicalTrials.gov Identifier:

NCT01155219

First received: June 30, 2010

Last updated: July 1, 2010

Last verified: July 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	June 30, 2010
Last Updated Date	July 1, 2010
Start Date ^ICMJE	July 2008
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 30, 2010)	Ocular tolerance [ Designated as safety issue: Yes ] Ocular symptoms Objective ocular signs
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01155219 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 1, 2010)	Efficacy on intraocular pressure (IOP) [ Time Frame: 84 days ] [ Designated as safety issue: No ] The maintenance of the intraocular pressure (IOP) efficient lowering effect. Comparison between the 2 study products of the mean basal intraocular pressure (IOP) after a 12 weeks treatment period (84 days ± 7).
Original Secondary Outcome Measures ^ICMJE (submitted: June 30, 2010)	Efficacy on intraocular pressure (IOP) [ Time Frame: 84 days ] [ Designated as safety issue: No ] The maintenance of the IOP efficient lowering effect. Comparison between the 2 study products of the mean basal IOP after a 12 weeks treatment period (84 days ± 7).
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety, Efficacy Assessment of Geltim LP® 1 mg/g in Ocular Hypertensive or Glaucomatous Patients.
Official Title ^ICMJE	Safety and Efficacy Assessment of Geltim LP® 1 mg/g (Unpreserved Timolol Gel - TG1030) in Ocular Hypertensive or Glaucomatous Patients Stabilized by Xalatan® With Ocular Intolerance Signs.
Brief Summary	This phase IV study aims to assess the safety and the efficacy in intra ocular pressure of Geltim LP® 1 mg/g (0.1% unpreserved timolol maleate gel) in glaucomatous patients initially treated and stabilised by monotherapy of Xalatan® with ocular objective signs of intolerance to prostaglandin eye drops.
Detailed Description	The primary objectives are to compare the safety and the efficacy of Geltim LP® 1mg/g eye drops versus Xalatan® eye drops with respect to: The assessment of the ocular tolerance: Ocular symptoms Objective ocular signs. The maintain of the IOP efficient lowering effect. Comparison between the 2 study products of the mean basal IOP after a 12 weeks treatment period (84 days ±7).
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Glaucoma
Intervention ^ICMJE	Drug: Geltim LP 1 mg/g one drop in the conjunctival sac of each eye in the morning (84 days). Drug: Xalatan one drop in the conjunctival sac of each eye in the morning (84 days).
Study Arm (s)	Experimental: Geltim LP® Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days). Intervention: Drug: Geltim LP 1 mg/g Active Comparator: Xalatan® Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days. Intervention: Drug: Xalatan
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	151
Completion Date	December 2009
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Written informed consent. Association of the 4 following criteria: - Bilateral primary open angle glaucoma or bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day), - With local intolerance signs. Exclusion Criteria: Presence of severe objective ocular sign. Any ocular hypertension other than primary ocular hypertension or primary chronic open angle glaucoma (such as congenital, angle closure glaucoma, secondary glaucoma). Absolute defect in the ten degrees central point of the visual field. Best far corrected visual acuity ≤ 1/10.
Gender	Both
Ages	18 Years to 90 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01155219
Other Study ID Numbers ^ICMJE	LTG1030-PIV-12/07
Has Data Monitoring Committee	No
Responsible Party	Marielle Estrade - Clinical Project Leader, Laboratoires Théa
Study Sponsor ^ICMJE	Laboratoires Thea
Collaborators ^ICMJE	AXONAL CSD Medical Research VEEDA
Investigators ^ICMJE	Not Provided
Information Provided By	Laboratoires Thea
Verification Date	July 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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