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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
  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
Intervention Model: Parallel Assignment
Masking: None (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 [ 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.


Enrollment: 150
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155219


Locations
France
Clermont-Ferrand, France, 63000
Sponsors and Collaborators
Laboratoires Thea
  More Information

Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT01155219     History of Changes
Other Study ID Numbers: LTG1030-PIV-12/07
First Submitted: June 30, 2010
First Posted: July 1, 2010
Results First Submitted: October 24, 2014
Results First Posted: October 29, 2014
Last Update Posted: April 4, 2017
Last Verified: July 2010

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