Postoperative Ocular Pain After PRK Surgery Clinical Trial
Official title:
A Randomized, Vehicle-controlled, Subject and Investigator-masked, Proof-of-concept Study to Evaluate the Use of Topical Ocular SAF312 in the Treatment of Postoperative Ocular Pain in Patients Undergoing Photorefractive Keratectomy (PRK) Surgery
| Verified date | October 2021 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine if SAF312 eye drops have an adequate safety and efficacy profile to justify further clinical development for the treatment of ocular pain associated with corneal epithelial defect such as after photorefractive keratectomy (PRK) surgery
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | February 21, 2018 |
| Est. primary completion date | January 15, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Normal eye exam except for refractive error at baseline. - Myopia should not exceed -4.00 Diopters (sphere) and 3.00 diopters of astigmatism, with spherical equivalent not higher than -4.50, confirmed by manifest refraction at baseline. Exclusion Criteria: - Monocular patient (including amblyopia) or best corrected visual acuity score worse than 20/80 (Snellen) or 55 letters (EDTRS), at baseline. - Any systemic or ocular disease that might affect wound healing (such as severe rheumatoid arthritis or diabetes or history of keloid formation) or a history of ocular trauma, uveitis, infection, or inflammation in the 6 months prior to baseline. - Previous refractive or corneal surgery (such as LASIK, PRK, radial keratotomy, pterygium removal, corneal transplantation). - Chronic pain of any etiology or any significant illness which has not resolved within two (2) weeks prior to initial dosing. Other inclusion and exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Novartis Investigative Site | Chevy Chase | Maryland |
| United States | Novartis Investigative Site | Draper | Utah |
| United States | Novartis Investigative Site | Norfolk | Virginia |
| United States | Novartis Investigative Site | Sioux Falls | South Dakota |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Visual Analog Scale (VAS) Pre-dose Pain Assessment | VAS pain severity scale pre-dose, 6 hours post-operatively. The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain | 6 hours | |
| Primary | Average Ocular Pain VAS Assessments | VAS pain severity scale from the first post-operative assessment to pre-dose 12 hours post-operative assesment The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain | 12 hours | |
| Secondary | Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication) | Summary of oral rescue medication use incidence (number of patients who DID NOT use oral rescue medication) | 6,12, 24, 48 and 72 hours post-operatievly | |
| Secondary | VAS Pain Assessments | VAS pain assessment during the first 72 hours post-operatively. VAS pain severity scale from the first post-operative assessment to pre-dose 12 hours post-operative assesment The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain | 72 hours | |
| Secondary | Plasma Concentration of SAF312 | C Max | day1, day 4 |