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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01155219
First received: June 30, 2010
Last updated: October 24, 2014
Last verified: July 2010
Results First Received: October 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Glaucoma
Interventions: Drug: Geltim LP 1 mg/g
Drug: Xalatan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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).

Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days).

Xalatan®

Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.

Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days).


Participant Flow:   Overall Study
    Geltim LP®     Xalatan®  
STARTED     77     73  
COMPLETED     73     70  
NOT COMPLETED     4     3  
Adverse Event                 3                 1  
non-medical reason                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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).

Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days).

Xalatan®

Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.

Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days).

Total Total of all reporting groups

Baseline Measures
    Geltim LP®     Xalatan®     Total  
Number of Participants  
[units: participants]
  77     73     150  
Age  
[units: years]
Mean (Standard Deviation)
  65.94  (11.79)     64.86  (11.62)     65.41  (11.68)  
Gender  
[units: participants]
     
Female     49     50     99  
Male     28     23     51  
Region of Enrollment  
[units: participants]
     
France     77     73     150  



  Outcome Measures

1.  Primary:   Ocular Tolerance   [ Time Frame: Day 84 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr Pascale Pouliquen
Organization: Laboratoires Thea
phone: 0473981436
e-mail: p.pouliquen@laboratoires-thea.fr


No publications provided


Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT01155219     History of Changes
Other Study ID Numbers: LTG1030-PIV-12/07
Study First Received: June 30, 2010
Results First Received: October 24, 2014
Last Updated: October 24, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)