Health Condition 1: H28- Cataract in diseases classified elsewhere
Conditions
Interventions
Intervention1: Phenylephrine HCl 1 percent and Ketorolac 0.3 percent intra-ocular solution of Odin Pharmaceuticals LLC.: Single use during the surgery: Four (4) mL of IP will be diluted in 500 mL of o
Sponsors
Odin Pharmaceuticals, LLC
Eligibility
Inclusion criteria
Inclusion criteria: Willing and able to provide written informed consent prior to any study-related activities being performed. Able and willing to comply with the clinical study protocol and associated study procedures, completion of PDC and availability for all scheduled study visits. Male or non-pregnant & non-lactating female patients of aged 18 years and above. Patient willing to undergo unilateral CELR procedure, under topical anesthesia with a phacoemulsification device with insertion of foldable lens. Have a BCVA of 20/400 or better in the non-study eye. Have an intra-ocular pressure between 5-22 mm Hg (both inclusive) in the study eye. Screening laboratory tests that are either normal or within acceptable limits or are of no clinical significance with respect to participation in the study as confirmed by the investigator. For female patients: Post-menopausal patients (defined as no menstrual period for = 12 months). For women of child bearing potential (WOCBP: defined as women physiologically capable of becoming pregnant): - Negative urine pregnancy test at screening visit (Visit 1: day -28 to -4). - Using 02 medically acceptable methods of contraception from 4-weeks prior to screening to 4-weeks after completing the surgery. Note: Acceptable methods of contraception that may be used by the patient and/or partner include, but are not limited to: a. Intrauterine device or intrauterine system or diaphragm with vaginal spermicide b. Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent) c. Oral contraception or NuvaRing or transdermal systems or progestin implant or injection for at least 3 months prior to the day of cataract surgery in the study d. Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that patient) e. Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation Total abstinence or partial abstinence is not acceptable.
Exclusion criteria
Exclusion criteria: With known history of allergy or hypersensitivity to Phenylephrine, Ketorolac or other NSAIDs, including Aspirin or any of the excipients of the IP formulation. With known history of allergy or hypersensitivity to Moxifloxacin or other fluoroquinolones, Lidocaine / Tetracaine, Tropicamide, topical corticosteroids, viscoelastic agent (Sodium chondroitin sulfate and sodium hyaluronate), or latex. Use of Phenylephrine (other than for the screening ophthalmological examination and used as mydriatic agent prior to surgery) or NSAIDs including Ketorolac, within 7 days prior to the day of surgery. Use of topical, inhaled, or oral corticosteroids within 7 days prior to the day of surgery or depot corticosteroids within 30 days prior to the day of surgery. Use of monoamine oxidase (MAO) inhibitors within 21 days prior to the day of surgery. Use of ocular mast cell stabilizers within 7 days prior or after to the day of surgery. Repeated use of Pilocarpine in the study eye within 6 months prior to the day of surgery. History of use of an a-1-adrenergic antagonist, such as Tamsulosin, Silodosin, Prazosin, Alfuzosin, Doxazosin, or Terazosin. Presence of narrow-angle glaucoma or unstable glaucoma. Glaucoma being treated with prostaglandins or prostaglandin analogs such as Latanoprost, Bimatoprost, Travoprost, Unoprostone, or Brimonidine in either eye. Anticipated to require the use of other topical ocular medications in either eye during the trial except prophylactic antibiotics, topical lid care, allowed glaucoma medications or non-prescription tear replacement solutions. Presence of pseudo-capsular exfoliation in either eye. History of iritis, or of any ocular trauma with iris damage in the eye. Presence of uncontrolled chronic ocular diseases in either eye. Presence of active corneal pathology or scarring noted in either eye (except superficial punctate keratopathy in the non-study eye). Presence of extraocular/intraocular inflammation in either eye. Presence of active bacterial and/or viral infection in either eye. History of intraocular non-laser surgery in the study eye within the 3 months prior to the day of surgery, or intraocular laser surgery in the study eye within 30 days prior to the day of surgery. Requiring or planning other ocular surgery during the study. Presence of any connective tissue disorder (e.g. lupus, rheumatoid arthritis, fibromyalgia). Presence of systolic blood pressure (SBP) of = 160 mm Hg or = 90 mm Hg, or diastolic blood pressure (DBP) of = 110 mm Hg or = 40 mm Hg. Presence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, haematological, endocrine, neurological, psychiatric, respiratory, or other medical or surgical condition as determined by the investigator. With a history of drug or alcohol abuse or addiction within the 12 months prior to screening visit (day -28 to -4). Female patients who are planning to become pregnant during the study period (4 weeks prior to screening till 4-weeks after completing the surgery), or are lactating/nursing or pregnant. Received any investigational medication within 30 days, or within 5 times its half-life, whichever is longer, prior to screening visit (day -28 to -4) or participating in any investigational drug or device trial within the 30 days prior to the day of surgery. Invest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pupil diameter (mm) over time from baseline during surgery. Post-operative ocular pain measured by visual analog scale (VAS) score.Timepoint: Measured by the masked central reader using still images of pupil at one-minute intervals over a time interval obtained from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) from the video recordings of each patient’s CELR procedure. 2, 4, 6, 8 and 10-12 hours post-surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with pupil diameter of at least 6 mm Proportion of patients with pupil diameter less than 6 mm Post-surgery ocular pain VAS score Proportion of patients with moderate to severe ocular pain (VAS greater than or equal to 40) Proportion of ocular pain free patients (VAS is equal to 0) Timepoint: At the completion of cortical clean-up during surgery At any time during the surgery At 24 hours, 48 hours day 7 and day 14 of post surgery during post hospitalization phase site visits At any time point during 12 hours post surgery At all time points during 12 hours post surgery ;Safety Outcome Frequency of adverse events AEs and serious adverse events SAEs Clinically significant changes in intraocular pressure IOP measurements Clinically significant changes in ophthalmological examinations Clinically significant vital sign measurements Timepoint: From screening to End of study [Day 30 ± 2] / Early discontinuation visit From screening to End of study [Day 30 ± 2] / Early discontinuation visit From screening to End of study [Day 30 ± 2] / Early discontinuation visit From screening to End of study [Day 30 ± 2] / Early discontinuation visit ;Photophobia measured on numerical rating scale NRS Post-surgery ocular inflammation as measured using slit lamp biomicroscope and rating the summed ocular inflammation score SOIS Post-surgery best-corrected visual acuity BCVA as measured using the Early Treatment Diabetic Retinopathy Study ETDRS visual acuity log scoreTimepoint: At 2 and 6 hours after completion of CELR procedure during the hospitalization phase, and at 24 hours 48 hours day 7 and day 14 post-surgery during post hospitalization phase site visits At 24 hours 48 hours day 7 and day 14 and day 30 post-surgery during post hospitalization phase site visits At 24 hours 48 hours day 7 day 14 and day 30 post-surgery during post hospitalization phase site visits | — |
Countries
India
Contacts
Public ContactMr Nimesh Parekh
COD Research Pvt Ltd
Outcome results
None listed