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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014