Clinical Study to Evaluate the Efficacy and Tolerability of an Anti-inflammatory/Antibiotic Treatment Following Ocular Cataract Extraction
NCT ID: NCT02973880
Last Updated: 2019-01-14
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
180 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-10-15
Study Completion Date
2018-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Study to Assess the Efficacy and Safety of SED80 for Use in Cataract Surgery
NCT04711213
Cataract in Inflammatory Ocular Disorders
COMPLETED
PHASE2
Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery
NCT02558218
Cataract
COMPLETED
NA
A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery
NCT04089735
Ocular Inflammation and Pain After Cataract Surgery
COMPLETED
PHASE2
Efficacy and Necessity of Anti-inflammatory Drops After Laser Peripheral Iridotomy
NCT02955641
Glaucoma, Closed-Angle
Glaucoma, Narrow-Angle
Glaucoma, Angle-Closure
UNKNOWN
NA
Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery
NCT00904904
Cataract
Inflammation
COMPLETED
PHASE4
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Cataract Extraction
Cataract
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Two treatment arms, test group versus active-comparator (control) group, treated in parallel.
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
All daily study products will be manufactured in indistinguishable single dose plastic vials, labeled in accordance with hour of administration. In accordance with the double-blind design of the study, daily treatment for patients randomized to group A (NETILDEX™ ophthalmic gel), will be of 2 doses of active treatment and 2 doses of indistinguishable placebo. For blinding purposes, Group B (NETILDEX™ eye drops solution) medications labels will consist in an aluminum envelope for each dose of the daily treatment, containing indistinguishable plastic vials of NETILDEX™ eye drops solution. Tertiary packaging (patient's treatment supply) will be a carton box appropriately labeled, containing 16 secondary packages (aluminum envelopes - each envelope containing 5 vials for each treatment time dose), containing enough plastic vials to allow the patient to complete the whole study treatment.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NETILDEX™ ophthalmic gel
1 drop of NETILDEX™ (Netilmicin Sulfate 3mg/ml / Dexamethasone Disodium Phosphate 1mg/ml) ophthalmic gel immediately after the surgery then 1 drop twice daily (b.i.d.) from Day 1 until Day 14 after surgery + 1 drop of XANTERGEL™ ophthalmic gel twice daily (b.i.d.) from Day 1 until Day 14 after surgery.
Bromfenac 0.9 mg/ml 1 drop twice daily (b.i.d.) for 3 days before cataract surgery.
Group Type
EXPERIMENTAL
NETILDEX™ ophthalmic gel
Intervention Type
DRUG
1 drop of NETILDEX™ (Netilmicin Sulfate 3mg/ml / Dexamethasone Disodium Phosphate 1mg/ml) ophthalmic gel immediately after the surgery then 1 drop twice daily (b.i.d.) from Day 1 until Day 14 after surgery + 1 drop of XANTERGEL™ ophthalmic gel twice daily (b.i.d.) from Day 1 until Day 14 after surgery.
Bromfenac 0.9 mg/ml 1 drop twice daily (b.i.d.) for 3 days before cataract surgery.
NETILDEX™ eye drops solution
1 drop of NETILDEX™ (Netilmicin Sulfate 3mg/ml / Dexamethasone Disodium Phosphate 1mg/ml) eye drops solution immediately after the surgery then 1 drop four times a day (q.i.d.) from Day 1 until Day 14 after surgery.
Bromfenac 0.9 mg/ml 1 drop twice daily (b.i.d.) for 3 days before cataract surgery.
Group Type
ACTIVE_COMPARATOR
NETILDEX™ eye drops solution
Intervention Type
DRUG
1 drop of NETILDEX™ (Netilmicin Sulfate 3mg/ml / Dexamethasone Disodium Phosphate 1mg/ml) eye drops solution immediately after the surgery then 1 drop four times a day (q.i.d.) from Day 1 until Day 14 after surgery.
Bromfenac 0.9 mg/ml 1 drop twice daily (b.i.d.) for 3 days before cataract surgery.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NETILDEX™ ophthalmic gel
1 drop of NETILDEX™ (Netilmicin Sulfate 3mg/ml / Dexamethasone Disodium Phosphate 1mg/ml) ophthalmic gel immediately after the surgery then 1 drop twice daily (b.i.d.) from Day 1 until Day 14 after surgery + 1 drop of XANTERGEL™ ophthalmic gel twice daily (b.i.d.) from Day 1 until Day 14 after surgery.
Bromfenac 0.9 mg/ml 1 drop twice daily (b.i.d.) for 3 days before cataract surgery.
Intervention Type
DRUG
NETILDEX™ eye drops solution
1 drop of NETILDEX™ (Netilmicin Sulfate 3mg/ml / Dexamethasone Disodium Phosphate 1mg/ml) eye drops solution immediately after the surgery then 1 drop four times a day (q.i.d.) from Day 1 until Day 14 after surgery.
Bromfenac 0.9 mg/ml 1 drop twice daily (b.i.d.) for 3 days before cataract surgery.
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Male or female Patients
2. Patients aged ≥ 40 years old
3. Patients undergoing cataract extraction surgery through phaco-emulsification and intra-ocular lens implantation
4. Patients with grade 2 or 3 according to LOCS III system for grading age-related cataract
5. Patients with transparent cornea (endothelial count in the limits for age but not lower than 1200 cells/mm2)
6. Patients understanding the nature of the study and providing their informed consent to participation
7. Patients willing and able to attend the visits and procedures foreseen by study protocol
8. Patients with negative Amsler Test at enrolment visit (V1)
2. Patients aged ≥ 40 years old
3. Patients undergoing cataract extraction surgery through phaco-emulsification and intra-ocular lens implantation
4. Patients with grade 2 or 3 according to LOCS III system for grading age-related cataract
5. Patients with transparent cornea (endothelial count in the limits for age but not lower than 1200 cells/mm2)
6. Patients understanding the nature of the study and providing their informed consent to participation
7. Patients willing and able to attend the visits and procedures foreseen by study protocol
8. Patients with negative Amsler Test at enrolment visit (V1)
Exclusion Criteria
* Patients with medical history of ocular inflammation diseases, Herpes infections, iritis, uveitis or Sjogren's syndrome
* Patients who have been treated for external ocular infections within a month before the study enrolment (V1)
* Patients with cellularity in the anterior ocular chamber ≥ grade 2 (16-25 cells / field 1x1 mm)
* Patients with flare in the anterior ocular chamber ≥ grade 2 (moderate)
* Patients with at least one of the following concomitant ocular diseases: ocular infections, uveitis, iritis, iridociclitis, glaucoma, diabetic retinopathy, diabetes, maculopathy, shallow anterior chamber (based on Investigator's judgment)
* Patients with PEX Syndrome (Pseudo-exfoliation syndrome)
* Patients with poor mydriasis, basing on Investigator's judgment
* Patients with intra-ocular pressure \> 24 mmHg
* Patients who have undergone surgery in the eye involved in the cataract extraction within the 12 months before the study enrolment (V1)
* Patients who have received corneal laser treatment in the eye involved in the cataract extraction within the 6 months before the study enrolment (V1)
* Patients with known or suspected allergy or hypersensitivity to ophthalmic preservatives, phenylacetic acid derivatives, aminoglycosides, Bromfenac, other NSAIDs, steroids
* Patients with traumatic cataract condition
* Patients who have been treated or are under treatment with alpha-blocking agents for more than 3 months before the study enrolment (V1)
* Patients who have received treatment with anti-histamines, decongestants, anti-inflammatory steroidal or non-steroidal (NSAID) drugs within the 15 days before the study enrolment (V1). Bromfenac, only, will be allowed for 3 days before cataract surgery
* Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment (V1)
* Patients receiving any ocular treatment, with the exception of artificial tears
* Female Patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical study and for three months later
* Female Patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception \*
* Monocle Patients
* Patients with epiretinal membrane as per OCT test at enrolment visit (V1)
* Methods at low risk of contraceptive failure (less than 1% per year) when used consistently, including: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), some intra-uterine devices, abstinence or vasectomized partner. Contraception should be maintained until treatment discontinuation.
* Patients who have been treated for external ocular infections within a month before the study enrolment (V1)
* Patients with cellularity in the anterior ocular chamber ≥ grade 2 (16-25 cells / field 1x1 mm)
* Patients with flare in the anterior ocular chamber ≥ grade 2 (moderate)
* Patients with at least one of the following concomitant ocular diseases: ocular infections, uveitis, iritis, iridociclitis, glaucoma, diabetic retinopathy, diabetes, maculopathy, shallow anterior chamber (based on Investigator's judgment)
* Patients with PEX Syndrome (Pseudo-exfoliation syndrome)
* Patients with poor mydriasis, basing on Investigator's judgment
* Patients with intra-ocular pressure \> 24 mmHg
* Patients who have undergone surgery in the eye involved in the cataract extraction within the 12 months before the study enrolment (V1)
* Patients who have received corneal laser treatment in the eye involved in the cataract extraction within the 6 months before the study enrolment (V1)
* Patients with known or suspected allergy or hypersensitivity to ophthalmic preservatives, phenylacetic acid derivatives, aminoglycosides, Bromfenac, other NSAIDs, steroids
* Patients with traumatic cataract condition
* Patients who have been treated or are under treatment with alpha-blocking agents for more than 3 months before the study enrolment (V1)
* Patients who have received treatment with anti-histamines, decongestants, anti-inflammatory steroidal or non-steroidal (NSAID) drugs within the 15 days before the study enrolment (V1). Bromfenac, only, will be allowed for 3 days before cataract surgery
* Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment (V1)
* Patients receiving any ocular treatment, with the exception of artificial tears
* Female Patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical study and for three months later
* Female Patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception \*
* Monocle Patients
* Patients with epiretinal membrane as per OCT test at enrolment visit (V1)
* Methods at low risk of contraceptive failure (less than 1% per year) when used consistently, including: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), some intra-uterine devices, abstinence or vasectomized partner. Contraception should be maintained until treatment discontinuation.
Minimum Eligible Age
40 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sintesi Research Srl
INDUSTRY
Sponsor Role
collaborator
SIFI SpA
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Aldo Caporossi, MD, Prof.
Role: PRINCIPAL_INVESTIGATOR
Policlinico Universitario A. Gemelli
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Klinikum Ernst von Bergmann Ophthalmologie
Potsdam, , Germany
Site Status
Augenklinik und Poliklinik Ophthalmologie
Würzburg, , Germany
Site Status
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Site Status
Azienda Ospedaliera Fatebenefratelli e Oftalmico
Milan, , Italy
Site Status
Policlinico Universitario A. Gemelli
Roma, , Italy
Site Status
Centrul Medical Unirea
Bucharest, , Romania
Site Status
Spitalul Universitar de Urgenta Bucuresti
Bucharest, , Romania
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Germany
Italy
Romania
References
Explore related publications, articles, or registry entries linked to this study.
Harrer A, Gerstmeyer K, Hirnschall N, Pesudovs K, Lundstrom M, Findl O. Impact of bilateral cataract surgery on vision-related activity limitations. J Cataract Refract Surg. 2013 May;39(5):680-5. doi: 10.1016/j.jcrs.2012.11.028. Epub 2013 Mar 25.
Reference Type
BACKGROUND
Porela-Tiihonen S, Kaarniranta K, Kokki H. Postoperative pain after cataract surgery. J Cataract Refract Surg. 2013 May;39(5):789-98. doi: 10.1016/j.jcrs.2013.03.012.
Reference Type
BACKGROUND
Monnet D, Tepenier L, Brezin AP. Objective assessment of inflammation after cataract surgery: comparison of 3 similar intraocular lens models. J Cataract Refract Surg. 2009 Apr;35(4):677-81. doi: 10.1016/j.jcrs.2008.12.021.
Reference Type
BACKGROUND
Goodman DF, Stark WJ, Gottsch JD. Complications of cataract extraction with intraocular lens implantation. Ophthalmic Surg. 1989 Feb;20(2):132-40.
Reference Type
BACKGROUND
Perry HD, Donnenfeld ED. An update on the use of ophthalmic ketorolac tromethamine 0.4%. Expert Opin Pharmacother. 2006 Jan;7(1):99-107. doi: 10.1517/14656566.7.1.99.
Reference Type
BACKGROUND
Sandoval HP, Fernandez de Castro LE, Vroman DT, Solomon KD. A review of the use of ketorolac tromethamine 0.4% in the treatment of post-surgical inflammation following cataract and refractive surgery. Clin Ophthalmol. 2007 Dec;1(4):367-71.
Reference Type
BACKGROUND
Alio JL, Sayans JA, Chipont E. Laser flare-cell measurement of inflammation after uneventful extracapsular cataract extraction and intraocular lens implantation. J Cataract Refract Surg. 1996;22 Suppl 1:775-9. doi: 10.1016/s0886-3350(96)80161-1.
Reference Type
BACKGROUND
Pande MV, Spalton DJ, Kerr-Muir MG, Marshall J. Postoperative inflammatory response to phacoemulsification and extracapsular cataract surgery: aqueous flare and cells. J Cataract Refract Surg. 1996;22 Suppl 1:770-4. doi: 10.1016/s0886-3350(96)80160-x.
Reference Type
BACKGROUND
Laurell CG, Zetterstrom C, Philipson B, Syren-Nordqvist S. Randomized study of the blood-aqueous barrier reaction after phacoemulsification and extracapsular cataract extraction. Acta Ophthalmol Scand. 1998 Oct;76(5):573-8. doi: 10.1034/j.1600-0420.1998.760512.x.
Reference Type
BACKGROUND
El-Harazi SM, Feldman RM. Control of intra-ocular inflammation associated with cataract surgery. Curr Opin Ophthalmol. 2001 Feb;12(1):4-8. doi: 10.1097/00055735-200102000-00002.
Reference Type
BACKGROUND
Rotsos TG, Moschos MM. Cystoid macular edema. Clin Ophthalmol. 2008 Dec;2(4):919-30. doi: 10.2147/opth.s4033.
Reference Type
BACKGROUND
Gulkilik G, Kocabora S, Taskapili M, Engin G. Cystoid macular edema after phacoemulsification: risk factors and effect on visual acuity. Can J Ophthalmol. 2006 Dec;41(6):699-703. doi: 10.3129/i06-062.
Reference Type
BACKGROUND
Cho H, Wolf KJ, Wolf EJ. Management of ocular inflammation and pain following cataract surgery: focus on bromfenac ophthalmic solution. Clin Ophthalmol. 2009;3:199-210. doi: 10.2147/opth.s4806. Epub 2009 Jun 2.
Reference Type
BACKGROUND
Rajpal RK, Ross B, Rajpal SD, Hoang K. Bromfenac ophthalmic solution for the treatment of postoperative ocular pain and inflammation: safety, efficacy, and patient adherence. Patient Prefer Adherence. 2014 Jun 25;8:925-31. doi: 10.2147/PPA.S46667. eCollection 2014.
Reference Type
BACKGROUND
Korenfeld MS, Silverstein SM, Cooke DL, Vogel R, Crockett RS; Difluprednate Ophthalmic Emulsion 0.05% (Durezol) Study Group. Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain. J Cataract Refract Surg. 2009 Jan;35(1):26-34. doi: 10.1016/j.jcrs.2008.09.024.
Reference Type
BACKGROUND
Lorenz K, Dick B, Jehkul A, Auffahrt GU. Inflammatory response after phacoemulsification treated with 0.5% prednisolone acetate or vehicle. Graefes Arch Clin Exp Ophthalmol. 2008 Nov;246(11):1617-22. doi: 10.1007/s00417-008-0908-2. Epub 2008 Aug 26.
Reference Type
BACKGROUND
Comstock TL, Paterno MR, Singh A, Erb T, Davis E. Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery. Clin Ophthalmol. 2011;5:177-86. doi: 10.2147/OPTH.S16832. Epub 2011 Feb 10.
Reference Type
BACKGROUND
McGhee CN, Dean S, Danesh-Meyer H. Locally administered ocular corticosteroids: benefits and risks. Drug Saf. 2002;25(1):33-55. doi: 10.2165/00002018-200225010-00004.
Reference Type
BACKGROUND
Sanders DR, Kraff M. Steroidal and nonsteroidal anti-inflammatory agents. Effect on postsurgical inflammation and blood-aqueous humor barrier breakdown. Arch Ophthalmol. 1984 Oct;102(10):1453-6. doi: 10.1001/archopht.1984.01040031173012.
Reference Type
BACKGROUND
Corbett MC, Hingorani M, Boulton JE, Shilling JS. Subconjunctival betamethasone is of benefit after cataract surgery. Eye (Lond). 1993;7 ( Pt 6):744-8. doi: 10.1038/eye.1993.173.
Reference Type
BACKGROUND
Watson D, Noble MJ, Dutton GN, Midgley JM, Healey TM. Penetration of topically applied dexamethasone alcohol into human aqueous humor. Arch Ophthalmol. 1988 May;106(5):686-7. doi: 10.1001/archopht.1988.01060130748037.
Reference Type
BACKGROUND
Winfield AJ, Jessiman D, Williams A, Esakowitz L. A study of the causes of non-compliance by patients prescribed eyedrops. Br J Ophthalmol. 1990 Aug;74(8):477-80. doi: 10.1136/bjo.74.8.477.
Reference Type
BACKGROUND
ARMALY MF. EFFECT OF CORTICOSTEROIDS ON INTRAOCULAR PRESSURE AND FLUID DYNAMICS. I. THE EFFECT OF DEXAMETHASONE IN THE NORMAL EYE. Arch Ophthalmol. 1963 Oct;70:482-91. doi: 10.1001/archopht.1963.00960050484010. No abstract available.
Reference Type
BACKGROUND
BECKER B, MILLS DW. CORTICOSTEROIDS AND INTRAOCULAR PRESSURE. Arch Ophthalmol. 1963 Oct;70:500-7. doi: 10.1001/archopht.1963.00960050502012. No abstract available.
Reference Type
BACKGROUND
Bartlett JD, Woolley TW, Adams CM. Identification of high intraocular pressure responders to topical ophthalmic corticosteroids. J Ocul Pharmacol. 1993 Spring;9(1):35-45. doi: 10.1089/jop.1993.9.35.
Reference Type
BACKGROUND
Barry P, Cordovés L, Gardner S. ESCRS Guidelines for Prevention and Treatment of Endophthalmitis Following Cataract Surgery: Data, Dilemmas and Conclusions. The European Society for Cataract & Refractive Surgeons 2013
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-002138-63
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
044-SI
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
PRO-232 in Patients Subjected to Cataract Surgery
NCT07305987
RECRUITING
PHASE3
"A Prospective Study of the Efficacy of Intracameral Dexamethasone (Dexycu™) Compared to Standard of Care Treatment for Post-Cataract Surgical Pain and Anterior Chamber Inflammation"
NCT04781335
COMPLETED
PHASE4
Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery
NCT04739709
COMPLETED
PHASE3
Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo
NCT00405730
COMPLETED
PHASE3
Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Postoperative Inflammation in Cataract Surgery
NCT00331084
COMPLETED
NA
A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% 2 Times Daily (BID) and Bromfenac 0.09% 2 Times Daily (BID)
NCT01023724
COMPLETED
PHASE4
A Clinical Study to Assess the Efficacy and Safety of Dexamethasone Suspension for Cataract Surgery
NCT03687931
COMPLETED
PHASE1/PHASE2
Prednisolone Acetate Eye Drops for Pain Intervention in Second Eye Cataract Surgery
NCT06614348
NOT_YET_RECRUITING
PHASE2
Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study
NCT04810962
COMPLETED
PHASE3
A Two Chemoprophylaxis Approaches After Phacoemulsification Surgery
NCT03634852
COMPLETED
PHASE4
Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery
NCT01395069
COMPLETED
PHASE4
Diclofenac vs Dexamethasone in Combined Surgery
NCT00825864
COMPLETED
NA
Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery
NCT04812951
COMPLETED
EARLY_PHASE1
A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery
NCT00521456
COMPLETED
PHASE3
Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
NCT02208297
COMPLETED
PHASE3
A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%
NCT04273282
COMPLETED
PHASE4
Ocular Inflammation in Cataract Patients and Response to Treatment With Xiidra
NCT04120987
WITHDRAWN
PHASE4
Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery
NCT00136344
COMPLETED
NA
Acular LS vs. Nevanac in Post op Inflammation Following Cataract Surgery
NCT00348582
COMPLETED
PHASE4
A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery
NCT00524264
COMPLETED
PHASE3
A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery
NCT04205916
RECRUITING
PHASE4
Pain Expression in the Perioperative Period of Cataract Surgery
NCT01824927
UNKNOWN
NA
A Clinical Study of Tobradex AF
NCT00473070
COMPLETED
PHASE3
Impact of 0.1% and 0.2% Sodium Hyaluronate on Postoperative Discomfort Following Phacoemulsification Surgery
NCT03705949
COMPLETED
NA
Effect of Prophylactic Ketorolac on CME After Cataract Surgery
NCT00335439
COMPLETED
NA