PHASE II / PHASE III CLINICAL TRIAL- ANTIGLAUCOMA AGENTS

Study title: A Prospective, Randomised, Double blind/Open label, Parallel

group, Active/Placebo controlled study of efficacy and tolerability of a new
topical beta blocker LX456 in comparison with topical timolol maleate in
patients with primary open angle glaucoma

Objectives:

1. To compare the efficacy of a new topical beta blocker LX456 (2%) with
timolol maleate(0.5%) in POAG
2. To compare the tolerability of 2% LX456 with 0.5% timolol maleate in
POAG

Study design:

A prospective, randomised, double blind, active controlled, parallel group,

comparative study.

Study population:

Patients attending ophthalmology OPD, KIMS Hospital Research centre

(multicentric if phase III) and diagnosed as unilateral/ bilateral POAG.

Sample size:

120 subjects with POAG

Sampling:

Purposive sampling

Randomisation:

Simple randomisation
Inclusion criteria:

Patients of either genderbetween 20-60yrs of age, with newly diagnosed

unilateral or bilateral POAG, with either elevated IOP of 25mm Hg or
typical glaucomatous optic discs or visual field damage from glaucoma

Willingness to give written informed consent and availability for regular

follow up visits

Exclusion criteria:

History of ocular surgery/trauma, previous use of corticosteroids,

contact lens use, dry eyes, corneal abnormality.

Patients with systemic use of blockers, evidence of ocular infection,

advanced cataract, inflammation, or history of renal or hepatic
impairment within the last 3 months

Patients with contraindication for blockers (bradycardia,

decompensated heart failure, or obstructive airway disease).

Patients who have participated in any clinical trial with anti-glaucoma

agents in the past 3 weeks.

Study procedure:

After approval and clearance from IEC, written informed consent will be
obtained from all the eligible study subjects after fully explaining the study
procedure. The study subjects will be randomised into two groups of 60 each
to receive LX456(2%) or timolol maleate (0.5%). The study medications were
blinded to make the formulations identical in the colour, consistency, the
container. The medications will be instilled twice daily and the patients and
their attenders/caretakers will be thoroughly educated and trained to instill
the medications with due precautions about the proper storage.

A wash out period of 3 weeks will be allowed for patients who were
previously receiving anti-glaucoma drugs or participated in any clinical trials
involving anti-glaucoma drugs.
 Follow up examinations will be done at the end of 14th and 28th day of
treatment period. During this period Snellen visual acuity, slit-lamp
biomicroscopy, and measurement of the IOP will be done. Any untoward
adverse effects due to the study medications and also the compliance of the
patient will be noted during the follow up visits.

Investigations:

The following investigations will be done at the baseline, at the end

of 14th and 28th day.
Snellen visual acuity, Slit lamp biomicroscopy, IOP measurement with
Schiotz tonometer, fundoscopic examination, perimetry

Statistical analysis:

Chi square test and analysis of variance will be used.