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

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ClinicalTrials.gov Identifier: NCT02961062
Recruitment Status : Completed
First Posted : November 10, 2016
Results First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( 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

Condition or disease Intervention/treatment Phase
Postoperative Ocular Pain After PRK Surgery Drug: SAF312 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : January 15, 2018
Actual Study Completion Date : February 21, 2018

Arm Intervention/treatment
Experimental: Treatment Sequence 1 Drug: SAF312
Drug: Placebo
Placebo Comparator: Treatment Sequence 2 Drug: SAF312
Drug: Placebo



Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication) [ Time Frame: 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)

  2. VAS Pain Assessments [ Time Frame: 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

  3. Plasma Concentration of SAF312 [ Time Frame: day1, day 4 ]
    C Max



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961062


Locations
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United States, Maryland
Novartis Investigative Site
Chevy Chase, Maryland, United States, 20815
United States, South Dakota
Novartis Investigative Site
Sioux Falls, South Dakota, United States, 57108
United States, Utah
Novartis Investigative Site
Draper, Utah, United States, 84020
United States, Virginia
Novartis Investigative Site
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] April 11, 2017
Statistical Analysis Plan  [PDF] March 22, 2018


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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02961062     History of Changes
Other Study ID Numbers: CSAF312X2201
First Posted: November 10, 2016    Key Record Dates
Results First Posted: April 11, 2019
Last Update Posted: April 11, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
ocular pain
photorefractive keratectomy (PRK)
SAF312
corneal epithelial defect

Additional relevant MeSH terms:
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Eye Pain
Eye Manifestations
Eye Diseases
Signs and Symptoms
Pain
Neurologic Manifestations