Back to resultsSafety, Efficacy Assessment of Geltim LP® 1 mg/g in Ocular Hypertensive or Glaucomatous Patients. (T1030)
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Geltim LP 1 mg/g
Xalatan
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring 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
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Geltim LP®
Xalatan®
Arm Description
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).
Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.
Outcomes
Primary Outcome Measures
Ocular Tolerance
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01155219
Brief Title
Safety, Efficacy Assessment of Geltim LP® 1 mg/g in Ocular Hypertensive or Glaucomatous Patients.
Acronym
T1030
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Thea
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Geltim LP®
Arm Type
Experimental
Arm Description
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).
Arm Title
Xalatan®
Arm Type
Active Comparator
Arm Description
Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.
Intervention Type
Drug
Intervention Name(s)
Geltim LP 1 mg/g
Intervention Description
one drop in the conjunctival sac of each eye in the morning (84 days).
Intervention Type
Drug
Intervention Name(s)
Xalatan
Intervention Description
one drop in the conjunctival sac of each eye in the morning (84 days).
Primary Outcome Measure Information:
Title
Ocular Tolerance
Description
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.
Time Frame
Day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Safety, Efficacy Assessment of Geltim LP® 1 mg/g in Ocular Hypertensive or Glaucomatous Patients.
We'll reach out to this number within 24 hrs