NCT02961062

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 11, 2019

Completed
Last Updated

October 6, 2021

Status Verified

October 1, 2021

Enrollment Period

1.1 years

First QC Date

November 8, 2016

Results QC Date

February 19, 2019

Last Update Submit

October 4, 2021

Conditions

Postoperative Ocular Pain After PRK Surgery

Keywords

ocular painphotorefractive keratectomy (PRK)SAF312corneal epithelial defect

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • 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

  • VAS Pain Assessments

    72 hours

  • Plasma Concentration of SAF312

    day1, day 4

Study Arms (2)

Treatment Sequence 1

EXPERIMENTAL
Drug: SAF312Drug: Placebo

Treatment Sequence 2

PLACEBO COMPARATOR
Drug: SAF312Drug: Placebo

Interventions

SAF312DRUG
Treatment Sequence 1Treatment Sequence 2
PlaceboDRUG
Treatment Sequence 1Treatment Sequence 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novartis Investigative Site

Chevy Chase, Maryland, 20815, United States

Location

Novartis Investigative Site

Sioux Falls, South Dakota, 57108, United States

Location

Novartis Investigative Site

Draper, Utah, 84020, United States

Location

Novartis Investigative Site

Norfolk, Virginia, 23502, United States

Location

Related Publications (1)

  • Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.

    PMID: 36729473DERIVED

Related Links

MeSH Terms

Conditions

Eye Pain

Condition Hierarchy (Ancestors)

Eye ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPainNeurologic Manifestations

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
novartis.email@novartis.com
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 10, 2016

Study Start

December 1, 2016

Primary Completion

January 15, 2018

Study Completion

February 21, 2018

Last Updated

October 6, 2021

Results First Posted

April 11, 2019

Record last verified: 2021-10

Locations

US(4)