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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:
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
  Purpose

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.


Condition Intervention Phase
Glaucoma
 Drug: Geltim LP 1 mg/g
Drug: Xalatan
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Drug Information available for: Latanoprost
U.S. FDA Resources

Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • Ocular tolerance [ Designated as safety issue: Yes ]
    • Ocular symptoms
    • Objective ocular signs


Secondary Outcome Measures:
  • 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).


Enrollment: 151
Study Start Date: July 2008
Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
 Drug: Geltim LP 1 mg/g
one drop in the conjunctival sac of each eye in the morning (84 days).
Active Comparator: Xalatan®
Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.
 Drug: Xalatan
one drop in the conjunctival sac of each eye in the morning (84 days).

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).

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155219

Locations
France
Clermont-Ferrand, France, 63000
Sponsors and Collaborators
Laboratoires Thea
AXONAL
CSD Medical Research
VEEDA
  More Information

No publications provided

Responsible Party: Marielle Estrade - Clinical Project Leader, Laboratoires Théa
ClinicalTrials.gov Identifier: NCT01155219     History of Changes
Other Study ID Numbers: LTG1030-PIV-12/07
Study First Received: June 30, 2010
Last Updated: July 1, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Laboratoires Thea:
Bilateral Glaucoma
Bilateral ocular hypertension
Bilateral primary open angle glaucoma
Bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day)
With local intolerance signs in at least one eye

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Latanoprost
 Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013