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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS) Pre-dose Pain Assessment
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Treatment Sequence 1
Intervention: SAF312 (Drug)
Treatment Sequence 1
Intervention: Placebo (Drug)
Treatment Sequence 2
Intervention: SAF312 (Drug)
Treatment Sequence 2
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Visual Analog Scale (VAS) Pre-dose Pain Assessment
Time Frame: 6 hours
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
Average Ocular Pain VAS Assessments
Time Frame: 12 hours
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
Secondary Outcomes
- VAS Pain Assessments(72 hours)
- Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication)(6,12, 24, 48 and 72 hours post-operatievly)
- Plasma Concentration of SAF312(day1, day 4)