Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (P… (NCT02961062) | Clinical Trial Compass
CompletedPhase 2
Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) Surgery
United States40 participantsStarted 2016-12-01
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Visual Analog Scale (VAS) Pre-dose Pain Assessment