Efficacy and Safety assessment of LT2345 unpreserved eye drops versus Xalatan in ocular hypertensive ou glaucomatous patients.PHase III study, international, multicentre, randomised, investigator masked, 2 parallel groups, versus reference product in 360 evaluable patents treated for 3 months.

• Conditions: The study population is suffering from glaucoma.

• Registration Number: EUCTR2009-011157-41-PT
• Lead Sponsor: aboratoires Thea

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-06
• Last Update Posted: 7 April 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Patients will be eligible for inclusion if all these criteria are respected:
At Selection Visit:
-Signed and dated informed consent,
-Male or female aged from = 18 to = 90 years old,
-Association of the following criteria for the eligible eye(s):
-Chronic primary open angle glaucoma or chronic ocular
hypertension
-Already treated and controlled (since at least one year) by a
monotherapy of Xalatan® defined by:
•Stable IOP (= 18 mmHg),
And
•Stable visual field defined by two available visual field:
? the penultimate visual field performed within the last 18 months
? the last visual field performed within the last 6 months
? and with an interval of at least 6 months between both visual fields.
-Corneal thickness = 510 µm and = 560 µm.
At Inclusion Visit:
-IOP:
•IOP < 34 mmHg in BOTH eyes
And
•IOP = 22 mmHg in the eligible eye(s).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients fulfilling at the selection visit ONE OR MORE of the following
non inclusion criteria will not be included in the study:

Ophthalmic non-inclusion criteria (in either eye)
-Any secondary ocular hypertension (such as congenital glaucoma,
closed-angle glaucoma, secondary glaucoma, glaucoma after cataract
surgery,…).
-Any severe glaucoma defined by:
? an advanced cupping.
And/or
? for the visual field with:
•A severe field loss.
and/or
•A risk of visual field worsening as a consequence of
participation in the trial according to the investigator’s best
judgement.
and/or
•An absolute defect in the ten degree central point.
-Best far corrected visual acuity = 1/10.
-Aphakia.
-Known history of ocular allergy and/or severe blepharitis and/or
uveitis.
-History of traumatism, infection, ocular inflammation within
the 3 months before the selection visit.
-History of refractive surgery.
-Severe dry eye (for example, clinically relevant superficial
punctuate keratitis, epithelial erosions of the cornea and/or use of
dry eye medication with a frequency exceeding 8 instillations/day).
-Any abnormality preventing accurate assessment e.g. reliable
applanation tonometry, visual field examination.

Systemic/non ophthalmic non-inclusion criteria
-General history:
•Non controlled asthma.
•Any medical or surgical history, disorder or disease such as
acute or chronic severe organic disease: hepatic, endocrine, neoplasic,
haematological; immunosuppressive, infectious diseases, severe
psychiatric illness, relevant cardiovascular abnormalities, etc and/or
any complicating factor or structural abnormality, judged by the
investigator to be incompatible with the study.
-Known allergic hypersensitivity history to one of the
components of the study medications or to test products.

Specific non-inclusion criteria for women
-Pregnancy, lactation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified