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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01155219
First Posted: July 1, 2010
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Laboratoires Thea
June 30, 2010
July 1, 2010
October 24, 2014
October 29, 2014
April 4, 2017
July 2008
July 2009   (Final data collection date for primary outcome measure)
Ocular Tolerance [ Time Frame: Day 84 ]
Response defined as a combination of satisfactory or acceptable effect on IOP and a reduction of at least 20% of the total tolerance score in the worse eye.
Ocular Tolerance
  • Ocular symptoms
  • Objective ocular signs
Complete list of historical versions of study NCT01155219 on ClinicalTrials.gov Archive Site
Not Provided
Efficacy on intraocular pressure (IOP) [ Time Frame: 84 days ]
  • 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).
Not Provided
Not Provided
 
Safety, Efficacy Assessment of Geltim LP® 1 mg/g in Ocular Hypertensive or Glaucomatous Patients.
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.
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.

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).

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Glaucoma
  • 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).
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
December 2009
July 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent.
  • Association of the 4 following criteria:

    1. - Bilateral primary open angle glaucoma or bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day),
    2. - 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.
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01155219
LTG1030-PIV-12/07
No
Not Provided
Not Provided
Laboratoires Thea
Laboratoires Thea
Not Provided
Not Provided
Laboratoires Thea
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP