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Effect of nepafenac/dexamethasone fixed dose combination vs. its individual components (nepafenac and dexamethasone monotherapies) on postoperative inflammation after cataract surgery: a randomized, multicentre, blinded-assessor, parallel-group clinical study – NE.DE.F. STUDY
EU CTIS ID: 2025-523367-38-00
What this study is testing
Primary efficacy objective: To demonstrate the superiority of NEPA/DEXA FDC treatment compared with its components instilled alone (i.e., NEPA and DEXA) in the time to resolution of ocular inflammation after cataract surgery.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed written informed consent.
- Male or female, age ≥ 40 years.
- Scheduled routine unilateral cataract surgery to be performed via phacoemulsification and posterior chamber intraocular lens implantation after screening. Of note, patients affected by cataract in both eyes could be enrolled if scheduled to undergo unilateral cataract surgery.
- Patients willing to interrupt the use of contact lenses for the entire duration of the trial.
- Patients able and willing to follow all trial procedures.
- Females of childbearing potential must have a negative urine pregnancy test (dipstick) prior to the first IMP administration, and currently use or agree to use consistently and correctly (i.e., perfect use) a highly effective method of contraception for the individual patient and her partner(s) throughout the trial and for at least one full contraceptive cycle (when applicable). Highly effective methods of contraception include the following: a) implantable progestogen-only hormone contraception associated with inhibition of ovulation; b) Intrauterine Device (IUD); c) Intrauterine Hormone-releasing System (IUS); d) combined (oestrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral; intravaginal; transdermal), provided the patient has been using that hormonal contraceptive for an adequate period of time to ensure effectiveness; e) progestogen-only hormone contraception associated with inhibition of ovulation (oral; injectable), provided the patient has been using that hormonal contraceptive for an adequate period of time to ensure effectiveness; f) vasectomized partner, provided that the partner is the sole patient’s sexual partner and the absence of sperm has been confirmed; g) bilateral tubal occlusion or tubal ligation; h) sexual abstinence, defined as refraining from heterosexual intercourse during the entire period of risk associated with the IMP (i.e., up to 24h after the end of treatment). Barrier contraceptives (i.e., diaphragm or cervical cap with spermicide and/or condoms [male or female] with or without a spermicidal agent) are not considered highly effective methods of contraception, and thus must not be used as sole method of contraception. Of note, females who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal (at least 12 months of amenorrhea following cessation of all exogenous hormonal treatment) are not considered of childbearing potential.
You likely can't join if
- Ocular conditions that, at the discretion of the Investigator, may interfere with the efficacy and/or safety evaluations (e.g., uveitis, diabetic retinopathy, retinal vasculitis, pseudo-exfoliation syndrome, intra-operative floppy iris syndrome, and any preoperative sign of intraocular inflammation in either eye).
- Known hypersensitivity to any component of the investigational products, procedural medications, salicylates or other NSAIDs.
- Contraindications to ocular treatment with nepafenac (Nevanac®), dexamethasone (Dexavision®) or nepafenac/dexamethasone FDC as follows: - Uncontrolled eye infections: 1) epithelial Herpes simplex keratitis (dendritic keratitis), vaccinia, varicella zoster and other viral infections of the cornea and conjunctiva; 2) fungal and acute purulent bacterial infections, including Pseudomonas and mycobacterial infections; 3) amoebic keratitis - Perforation, ulceration and injury of cornea with uncompleted epithelialization - Known corticosteroid-induced intraocular hypertension.
- Participation in a clinical study in the last month before screening or within 5 half-lives of the Investigational Medicinal Product (IMP) used in the previous studies, whichever is longer.
- Pregnancy or breastfeeding throughout the whole study duration.
- Patients undergoing bilateral cataract surgery at the same time.
See the full eligibility criteria
Who can join
- Signed written informed consent.
- Male or female, age ≥ 40 years.
- Scheduled routine unilateral cataract surgery to be performed via phacoemulsification and posterior chamber intraocular lens implantation after screening. Of note, patients affected by cataract in both eyes could be enrolled if scheduled to undergo unilateral cataract surgery.
- Patients willing to interrupt the use of contact lenses for the entire duration of the trial.
- Patients able and willing to follow all trial procedures.
- Females of childbearing potential must have a negative urine pregnancy test (dipstick) prior to the first IMP administration, and currently use or agree to use consistently and correctly (i.e., perfect use) a highly effective method of contraception for the individual patient and her partner(s) throughout the trial and for at least one full contraceptive cycle (when applicable). Highly effective methods of contraception include the following: a) implantable progestogen-only hormone contraception associated with inhibition of ovulation; b) Intrauterine Device (IUD); c) Intrauterine Hormone-releasing System (IUS); d) combined (oestrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral; intravaginal; transdermal), provided the patient has been using that hormonal contraceptive for an adequate period of time to ensure effectiveness; e) progestogen-only hormone contraception associated with inhibition of ovulation (oral; injectable), provided the patient has been using that hormonal contraceptive for an adequate period of time to ensure effectiveness; f) vasectomized partner, provided that the partner is the sole patient’s sexual partner and the absence of sperm has been confirmed; g) bilateral tubal occlusion or tubal ligation; h) sexual abstinence, defined as refraining from heterosexual intercourse during the entire period of risk associated with the IMP (i.e., up to 24h after the end of treatment). Barrier contraceptives (i.e., diaphragm or cervical cap with spermicide and/or condoms [male or female] with or without a spermicidal agent) are not considered highly effective methods of contraception, and thus must not be used as sole method of contraception. Of note, females who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal (at least 12 months of amenorrhea following cessation of all exogenous hormonal treatment) are not considered of childbearing potential.
- Additional criteria for randomization (to be verified at Visit 2 after surgery): The participant has undergone unilateral cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in the study eye without any additional procedures or complications that would, in the opinion of the Investigator, interfere with trial procedures or confound trial objectives.
What rules you out
- Ocular conditions that, at the discretion of the Investigator, may interfere with the efficacy and/or safety evaluations (e.g., uveitis, diabetic retinopathy, retinal vasculitis, pseudo-exfoliation syndrome, intra-operative floppy iris syndrome, and any preoperative sign of intraocular inflammation in either eye).
- Known hypersensitivity to any component of the investigational products, procedural medications, salicylates or other NSAIDs.
- Contraindications to ocular treatment with nepafenac (Nevanac®), dexamethasone (Dexavision®) or nepafenac/dexamethasone FDC as follows: - Uncontrolled eye infections: 1) epithelial Herpes simplex keratitis (dendritic keratitis), vaccinia, varicella zoster and other viral infections of the cornea and conjunctiva; 2) fungal and acute purulent bacterial infections, including Pseudomonas and mycobacterial infections; 3) amoebic keratitis - Perforation, ulceration and injury of cornea with uncompleted epithelialization - Known corticosteroid-induced intraocular hypertension.
- Participation in a clinical study in the last month before screening or within 5 half-lives of the Investigational Medicinal Product (IMP) used in the previous studies, whichever is longer.
- Pregnancy or breastfeeding throughout the whole study duration.
- Patients undergoing bilateral cataract surgery at the same time.
- Ocular surgery in the study eye (including laser surgery) in the 3 months before screening.
- Patients under treatment with prostaglandin analogues or intravitreal injections of anti-Vascular Endothelial Growth Factor (VEGF) drugs, the latter with the last anti-VGEF injections within 3 months before surgery and/or injections scheduled during surgery or the following 2 weeks.
- Use of topical ocular, systemic, or inhaled NSAIDs within 1 week of surgery; use of topical ocular, inhaled, or systemic corticosteroids within 15 days of surgery; use of intraocular or periocular injection of steroids within 3 months of surgery. Of note, the use of low-dose acetylsalicylic acid for cardiovascular disease prevention is allowed.
- Systemic diseases that may have an impact on would healing and/or affect the resolution of inflammation after cataract surgery, and thus could interfere with the results of the study, as judged by the Investigator.
- Any condition that could interfere with the correct instillation of eye drops.
- Monocular patients.
- BCVA < 20/80 of the contralateral eye measured through Snellen 20 feet chart, equal to 0.25 decimal.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.