Cataracts MedDRA version: 20.0 Level: PT Classification code 10007739 Term: Cataract System Organ Class: 10015919 - Eye disorders MedDRA version: 20.0 Level: PT Classification code 10063797 Term: Cataract operation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Fydrane
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TROPICAMIDE
CAS Number: 1508-75-4
Other descriptive
Sponsors
Laboratoires Théa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patient aged 40 to 88 years, scheduled to undergo bilateral cataract surgery within the next 17 days (under topical anaesthesia and using clear corneal self-sealing incisions -phacoemulsification- foldable intraocular lens surgery with injector). 2. Pupil diameter =7 mm at selection visit after the following dilatation protocol: 1 drop of tropicamide 1% + 1 drop of phenylephrine 10%, with a maximum of 3 combined instillations at 10-minute intervals (i.e. time 0 minutes, time 0 + 10 minutes, and time 0 + 20 minutes), if necessary. 3. Scheduled use of intraocular lens injector Monarch II during the bilateral cataract surgery. 4. Patient willing and able to provide written informed consent prior to any study-related procedure and to comply with all study requirements. 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: 1. Patient who have combined surgery; previous intraocular and/or corneal surgery; iatrogenic, traumatic or congenital cataract; pupillary abnormalities (e.g. irregular); iris synechiae; eye movement disorder (e.g. nystagmus); dacryocystitis and all other pathologies of tear drainage system; history of inflammatory ocular disease (e.g. iritis, uveitis, herpetic keratitis); corneal, epithelial, stromal or endothelial residual or evolutionary disease (including corneal ulceration and superficial punctate keratitis); corneal, epithelial, stromal or endothelial residual or evolutionary disease (including corneal ulceration and superficial punctate keratitis); history of ocular traumatism, infection or inflammation within the last 3 months; pseudoexfoliation, exfoliative syndrome; in any eye. 2. Clinically significant ocular endothelial dysfunction. 3. Patients with a cataract hardness in one of the eyes and/or grade =3 as per the Lens Opacities Classification System III (LOCS III). 4. The following concomitant medications will not be allowed: systemic corticoid treatments and immunosuppressive treatments within 3 months before surgery; systemic opioids and morphinic drugs within 7 days before surgery, topical ocular treatment with mydriatic and/or anaesthetic action within 7 days before surgery; other systemic analgesics (except paracetamol) within 7 days before surgery; contact lenses within 7 days before surgery; topical treatment with anti-inflammatory and antibiotic action within 1 day before surgery (except for the preoperative treatment specified in this protocol); anxiolytics and hypnotics on the day of surgery; adrenaline or any other agent with a mydriatic action in the intraocular irrigating solution. 5. Any known ocular disorders affecting eye surface (i.e. staining grade >1 as per the Oxford schema). 6. Known hypersensitivity to the active substances (tropicamide, phenylephrine, lidocaine, oxybuprocain or tetracaine), any of their excipients, anaesthetics of the amide type or atropine derivatives. 7. Pregnancy or breastfeeding, in women of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the effects of Fydrane (after oxybuprocain chlorhydrate 0.4% + tetracaine chlorhydrate 0.1% eye-drop instillation) and the standard mydriatic-anaesthetic eye-drop protocol(oxybuprocain chlorhydrate 0.4% + tetracaine chlorhydrate 0.1%, phenylephrine 10% and tropicamide 1%) on ocular surface.; Secondary Objective: To assess changes in best corrected visual acuity recovery. To evaluate epithelial alterations. To describe changes in conjunctival hyperaemia. To assess changes in intraocular pressure. To evaluate the centre point-spread function by the objective scatter index (OSI) in the Optical Quality Analysis System (OQAS) HD AnalyzerTM. To determine changes in the Ocular Surface Disease Index (OSDI) questionnaire. To describe ocular symptoms/signs experienced by patients. To assess patients’ perceptions on satisfaction with study treatments. To determine satisfaction assessed by investigators. To describe the safety profile of study treatments. ;Primary end point(s): The primary endpoint is the change in corneal/conjunctival surface staining measured as per the Oxford schema (corneal staining with fluorescein) and van Bijsterveld schema (conjunctival staining with lissamine green) with Fydrane® versus the standard eye-drop protocol from baseline (visit 0) to 7 days post-surgery (visit 3). In addition, changes from baseline (visit 0) to just after surgery (visit 1) and from baseline (visit 0) to 12-36 hours post-surgery (visit 2) will be assessed.;Timepoint(s) of evaluation of this end point: The evaluation per eye is performed on the day of the surgery, 12-36 hours after surgery and 7 (±1) days after surgery. Estimated period: 28 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The change in best corrected visual acuity according to the Snellen test from baseline (visit 0) to 7 days post-surgery (visit 3). The percentage of patients with epithelial alterations evidenced by slit-lamp examination (i.e. none, mild, and significant) 12-36 hours post-surgery (visit 2). The change in conjunctival hyperaemia as per MacMonnies photographic scale (0 to 5) from baseline (right before study treatment administration at visit 1) to 7 days post-surgery (visit 3). In addition, changes in conjunctival hyperaemia from baseline (right before study treatment administration at visit 1) to just after surgery (visit 1) and from baseline (right before study treatment administration at visit 1) to 12-36 hours post-surgery (visit 2) will be described. The change in intraocular pressure from baseline (visit 0) to 7 days post-surgery (visit 3). Point-spread function measured by the objective scatter index (OSI) in the Optical Quality Analysis System (OQAS) HD AnalyzerTM 12-36 hours post-surgery (visit 2) and 7 days post-surgery (visit 3). ? The change in the Ocular Surface Disease Index (OSDI) from baseline (right before study treatment administration at visit 1) to 7 days post-surgery (visit 3). Percentages of patients with ocular symptoms as perceived by patients and signs assessed by investigators according to ordinal scales ranging from 0 (absent/none) to 3 (severe) 12-36 hours post-surgery (visit 2) and 7 days post-surgery (visit 3). Patients’ satisfaction with study treatments assessed on an ordinal scale ranging from 0 (very satisfactory) to 3 (unsatisfactory) just after surgery (visit 1). Satisfaction assessed by the investigators according to an ordinal scale ranging from 0 (very satisfactory) to 3 (unsatisfactory) just after surgery (visit 1). The incidence of adverse events related to study treatments. | — |
Countries
Spain
Contacts
Public ContactFátima González Hurtado
Dynamic Science S.L.
Outcome results
None listed