Cataract Clinical Trial
Official title:
A Prospective, Multi-center, Controlled, Double-blind Study to Evaluate the Efficacy and Tolerability of a Steroid/Antibiotic Associated Treatment Following Cataract Extraction by Means of Phaco-emulsification
Cataract is an ophthalmic disease that usually affects the elderly population. Cataract
surgery with phaco-emulsification is now the most frequently performed intraocular surgical
procedure in the developed world. However, differences in surgical technique impact the
severity of surgical trauma and post-operative recovery. The amount of post-operative ocular
pain and inflammation plays a significant role in the Patient's perception of the surgical
success.
Several ophthalmic products have been studied in the management of post-surgery ocular
inflammation and pain following cataract surgery. Corticosteroids are considered the gold
standard for the treatment of ocular inflammation, and their most commonly used route of
administration is the topical instillation as eye drops formulation.
After topical administration of Dexamethasone, the concentration in the anterior chamber
increases and declines within hours, necessitating frequent daily instillations of eye drops
for several weeks. This might be associated with compliance issues, particularly in elderly
Patients or in individuals with disabilities. A pharmaceutical formulation allowing for a
less frequent administration could therefore be an attractive alternative.
NETILDEX™ eye drops solution, containing Netilmicin Sulfate 4.55 mg (3mg/ml) and
Dexamethasone Disodium Phosphate 1.32 mg (1mg/ml), is already available for Patients. A new
ophthalmic gel, preservative-free formulation has been developed. This new formulation has
been tested in pre-clinical animal studies and in a clinical trial. The new formulation
contains Xanthan gum, a high molecular mass polysaccharide approved by the FDA in 1969 for
food products. It is used in the product as viscosity enhancer and to give to the product
pseudo-plastic characteristics and prolonged ocular retention time.
The purpose of this trial is to show that the administration of a reduced dose of NETILDEX ™
gel 2 times a day starting on the day of cataract extraction by means of phaco-emulsification
and administered until 14 days after surgery is sufficient to obtain a non-inferior efficacy
of the NETILDEX ™ eye drops solution administered 4 times a day for the same period.
Cataract is an ophthalmic disease that usually affects the elderly population. Therapy is
surgical and during the past decades, improvements in surgical techniques and instruments
have dramatically increased the number of cataract extractions performed.
With improvements in surgical techniques, Patients' expectations have risen proportionally;
however, differences in surgical technique impact the severity of surgical trauma and
post-operative recovery. Cataract surgery with phaco-emulsification is now the most
frequently performed intraocular surgical procedure in the developed world.
The amount of post-operative ocular pain and inflammation plays a significant role in the
Patient's perception of the surgical success.
Ocular inflammation, commonly observed after cataract surgery, is associated with a breakdown
of the blood-aqueous barrier (BAB) as a result of surgical trauma-induced prostaglandin
production.
Anterior chamber ocular inflammation, clinically assessed as anterior chamber cell counts and
flare, is also common following cataract surgery. However, post-surgery inflammation is
frequently viewed as an acceptable risk that is largely outweighed by the numerous benefits
of cataract surgery.
Advanced surgical techniques including phaco-emulsification, capsulorhexis, small clear
corneal incisions, improved visco-elastics and foldable implants have helped to optimize
post-surgery results and reduce surgical trauma. However, post-surgery inflammation may still
occur and can lead to complications such as corneal edema, intra-ocular pressure (IOP)
spikes, posterior capsule opacification and cystoid macular edema (CME).
The management of post-surgery inflammation is essential, both to ensure rapid recovery
following surgery, and to prevent or decrease the potential for long-term complications, such
as cystoid macular edema.
Several ophthalmic products have been studied for the management of post-surgery ocular
inflammation and pain following cataract surgery. The two main treatments for ocular
inflammation are topical corticosteroids or non-steroidal anti-inflammatory (NSAID) drugs.
Bromfenac is a potent inhibitor of the COX-2 enzyme and a highly lipophilic molecule that
rapidly penetrates to produce early and sustained drug levels in all ocular tissues. Studies
have shown that Bromfenac ophthalmic solution has equivalent efficacy to the other topical
NSAIDs in reducing post-operative inflammation and controlling pain.
In order to decrease both intra-surgical and post-operative inflammation, it is now becoming
commonplace to extend ophthalmic NSAID dosing to pre-operative use as well to reduce
inflammation and minimize the risk of post-surgery complications in particular to prevent
post-surgery cystoid macular edema.
Corticosteroids are considered the gold standard for the treatment of ocular inflammation,
they are routinely used to control post-surgery ocular inflammation. The most commonly used
route of administration of corticosteroid agents is the topical instillation as eye drops
formulation. Steroids can be used as an additional prophylactic treatment in high-risk cases.
After topical administration of Dexamethasone, the concentration in the anterior chamber
increases and declines within hours, necessitating frequent daily instillations of eye drops
for several weeks. This might be associated with compliance issues, particularly in elderly
Patients or in individuals with disabilities. A pharmaceutical formulation allowing for a
less frequent administration could therefore be an attractive alternative.
Increase in intra-ocular pressure (IOP) is a concern after the use of corticosteroids,
irrespective of the route of administration. Repeated use of topical steroids has been shown
to induce reversible elevations in IOP, especially in eyes with glaucoma.
Although most of the Patients develop an increase in IOP after 3-6 weeks of treatment with
topical steroids, some elevation of IOP can be found as early as the first or second week
after initiation of topical instillation of steroids.
NETILDEX™ eye drops solution, containing Netilmicin Sulfate 4.55 mg (3mg/ml) and
Dexamethasone Disodium Phosphate 1.32 mg (1mg/ml), is already available for Patients. A new
ophthalmic gel, preservative-free formulation has been developed. This new formulation has
been tested in pre-clinical animal studies and in a clinical trial. The new formulation
contains Xanthan gum, a high molecular mass polysaccharide approved by the FDA in 1969 for
food products and it is used in the product as viscosity enhancer and to give to the product
pseudo-plastic characteristics and prolonged ocular retention time. Its usability in
ophthalmic preparations is well known and another products containing Xanthan gum is
currently available in the market (Timolol GFS, Falcon Pharmaceuticals, USA).
The penetration in the target tissue of Netilmicin and Dexamethasone contained in NETILDEX ™
eye drops and NETILDEX™ ophthalmic gel has been studied in a pre-clinical study in rabbits,
which results suggest that the ophthalmic gel formulation increases the tissue
bioavailability of both active principles.
A clinical study has been conducted in 63 healthy volunteers (21 per group) to establish the
safety and ocular tolerability of NETILDEX ™ ophthalmic gel, in comparison with placebo and
eye drop solution, administered q.i.d. (1 drop) over a period of 14 days . Both formulations
were tolerated as placebo. A statistically significant difference between placebo and
Dexamethasone/Netilmicin was observed, as expected, for intra-ocular pressure (IOP) values,
however in none of the cases the IOP rising was clinically relevant.
The purpose of this trial is to show that the administration of a reduced dose of NETILDEX ™
gel 2 times a day starting on the day of cataract extraction by means of phaco-emulsification
and administered until 14 days after surgery is sufficient to obtain a non-inferior efficacy
of the NETILDEX ™ eye drops solution administered 4 times a day for the same period.
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