Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) Surgery

Phase 2

Completed

• Conditions: Postoperative Ocular Pain After PRK Surgery
• Interventions: Drug: SAF312; Drug: Placebo

• Registration Number: NCT02961062
• Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-10
• Study Start: 2016-12-01
• Primary Completion: 2018-01-15
• Study Completion: 2018-02-21
• Disposition First Submitted: 2018-06-06
• Disposition First Submitted QC: 2018-06-06
• Disposition First Posted: 2018-06-11
• Results First Submitted: 2019-02-19
• Results First Submitted QC: 2019-03-21
• Results First Posted: 2019-04-11
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Sequence 1	Placebo	-
Treatment Sequence 2	Placebo	-
Treatment Sequence 1	SAF312	-
Treatment Sequence 2	SAF312	-

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) Pre-dose Pain Assessment	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	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 Outcome Measures

Name	Time	Method
VAS Pain Assessments	72 hours	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
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	Summary of oral rescue medication use incidence (number of patients who DID NOT use oral rescue medication)
Plasma Concentration of SAF312	day1, day 4	C Max

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Norfolk, Virginia, United States