Phase 2
N=40
Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) Surgery
Postoperative Ocular Pain After PRK Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02961062 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Visual Analog Scale (VAS) Pre-dose Pain Assessment — 34.63; 45.76 score on a scale — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SAF312 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale (VAS) Pre-dose Pain Assessment |
34.63; 45.76 | 0.005 sig |
| PRIMARY Average Ocular Pain VAS Assessments |
30.90; 39.47 | 0.017 sig |
| SECONDARY Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication) |
23; 19; 19; 16; 16; 12 | — |
| SECONDARY VAS Pain Assessments |
5.13; 3.58 | — |
| SECONDARY Plasma Concentration of SAF312 |
0.454; 2.40 | — |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02961062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.