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Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04630158
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : December 28, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The study is designed to demonstrate the safety and efficacy of two dose concentrations of SAF312 eye drops (dose 1 and dose 2) in subjects with CICP persisting at least for 4 months after refractive or cataract surgery and chronicity confirmed during the observational period. The study will also determine the optimal dose to carry forward for further development.

Condition or disease Intervention/treatment Phase
Chronic Ocular Pain Other: SAF312 Placebo Drug: SAF312 Phase 2

Detailed Description:
This study is a Phase 2 randomized, double-blinded, multi-center, parallel group, placebo-controlled evaluation of the safety and efficacy of SAF312, 5 mg/ml and 15 mg/ml eye drops versus placebo used twice-daily in both eyes for 12 weeks. Eligible subjects will have undergone refractive surgery (i.e., PRK, LASIK, LASEK, RK, or SMILE) in both eyes or cataract surgery in both eyes with or without refractive enhancement in one or both eyes at least 4 months prior to Screening, and have been suffering from chronic ocular pain as a result of their surgery. Eligible patients must also demonstrate chronicity of the pain at Baseline Visit as described in inclusion criteria. Overall approximately 150 subjects will be enrolled in the study and randomized to one of 3 study arms in 1:1:1 ratio

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blinded
Primary Purpose: Treatment
Official Title: A 12-week Parallel Group, Randomized, Placebo-controlled, Double-blinded, Multi-center Study to Evaluate Efficacy and Safety of 2 Concentrations of SAF312 Eye Drops (5 mg/ml and 15 mg/ml) Used Twice-daily in the Treatment of Post-operative Corneal Induced Chronic Pain (CICP) Following Photorefractive Keratectomy (PRK) or Laser-assisted in Situ Keratomileusis (LASIK) Surgeries
Actual Study Start Date : April 21, 2021
Estimated Primary Completion Date : December 5, 2022
Estimated Study Completion Date : December 5, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Placebo Comparator: SAF312 Placebo
Randomized to a 1:1:1 topical eye drops, twice daily
Other: SAF312 Placebo
Topical ocular, suspension eye drops,
Other Name: Artificial tears

Experimental: SAF312 dose 1
Randomized to a 1:1:1 topical eye drops, twice daily
Drug: SAF312
Topical ocular, suspension eye drops

Experimental: SAF312 dose 2
Randomized to a 1:1:1 topical eye drops, twice daily
Drug: SAF312
Topical ocular, suspension eye drops




Primary Outcome Measures :
  1. Change in mean pain severity Visual Analog Scale [ Time Frame: 84 days ]

    To demonstrate the efficacy of at least 1 of 2 concentrations of SAF312 (dose 1 or dose 2) with superiority to placebo in reducing ocular pain severity.

    The pain severity Visual Analogue Scale (VAS) is completed by the subject using an electronic diary. A vertical mark is placed on the horizontal scoring line (anchored with 'No Pain' on the left and 'Very Severe' pain on the right) to score the severity of ocular pain over the past 24 hours (max score=100). Higher scores indicate higher pain severity.



Secondary Outcome Measures :
  1. Change in pain severity Visual Analog Scale [ Time Frame: Baseline, Day 7 and Day 14 ]

    To evaluate additional efficacy of 2 concentrations of SAF312 vs placebo (eg., time to pain severity improvement).

    The pain severity Visual Analogue Scale (VAS) is completed by the subject using an electronic diary. A vertical mark is placed on the horizontal scoring line (anchored with 'No Pain' on the left and 'Very Severe' pain on the right) to score the severity of ocular pain over the past 24 hours (max score=100). Higher scores indicate higher pain severity.


  2. Change in pain frequency Visual Analog Scale [ Time Frame: Baseline, Week 12 ]

    To evaluate additional efficacy of 2 concentrations of SAF312 vs placebo (eg., time to pain frequency improvement).

    The pain frequency Visual Analogue Scale (VAS) is completed by the subject using an electronic diary. A vertical mark is placed on the horizontal scoring line (anchored with 'Rarely' on the left and 'All the Time' on the right) to score the frequency of ocular pain over the past 24 hours (max score=100). Higher scores indicate higher pain frequency.


  3. Change in Ocular Pain Assessment Scale (OPAS) sub-scale Quality of Life [ Time Frame: Baseline, Week 12 ]

    To evaluate additional efficacy of 2 concentrations of SAF312 vs placebo (e.g., time to improvement in quality of life).

    Each question in the Ocular Pain Assessment Survey (OPAS) quality of life subscale is scored by the subject on a line marked from 0 (not at all) to 10 (completely) that describes how much pain has interfered with or affected a particular activity (max score= 10/question). A higher score suggests a higher impact by pain on a particular activity.


  4. Change in ocular surface parameters as assessed by the corneal fluorescein staining [ Time Frame: Baseline, Week 12 ]

    To evaluate if SAF312 has negative effects to the ocular surface after prolonged TRPV1 inhibition.

    The degree of corneal fluorescein staining in each of five regions (superior, inferior, nasal, temporal, and central) is graded on a scale from 0 to 4 (max score=20/eye). Higher scores suggest higher degrees of corneal staining (worsening).


  5. Change in ocular surface parameters as assessed by lissamine staining [ Time Frame: Baseline, Week 12 ]

    To evaluate if SAF312 has negative effects to the ocular surface after prolonged TRPV1 inhibition.

    The degree of lissamine conjunctival staining in two regions (temporal and nasal) is graded on a scale from 0 to 4 (max score = 8/eye). Higher scores suggest higher degrees of corneal staining (worsening).


  6. Change in ocular surface parameters as assessed by Schirmer's testing [ Time Frame: Baseline, Week 12 ]

    To evaluate if SAF312 has negative effects to the ocular surface after prolonged TRPV1 inhibition.

    The Schirmer's test will be performed without anesthetic. Tear secretion is measured in millimeters based on the length of strip wetted by tears (max score =35 mm/eye). Lower values indicate lower relative amounts of tear secretion (worsening).


  7. Change in ocular surface parameters as evaluated by the investigator using the McMonnies redness photographic scale. [ Time Frame: Baseline, Week 12 ]

    To evaluate if SAF312 has negative effects to the ocular surface after prolonged TRPV1 inhibition.

    Conjunctival redness in each of two regions (nasal and temporal) is graded on a scale from 0 to 5 using the McMonnies conjunctival redness photographic scale (max score=5/region). Higher scores suggest higher degrees of redness (worsening).


  8. Comparison of adverse events rates between active and placebo [ Time Frame: Baseline, End of Study (Day 88) ]

    To evaluate the safety of 2 concentrations of SAF312 (dose 1 and dose 2).

    Ocular and non-ocular adverse events will be summarized separately. Separate summaries also will be provided for study treatment related adverse events, death, serious adverse events, and other significant adverse events leading to discontinuation. Higher rates of adverse events in the active group compared to the placebo may suggest potential safety signals.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Subjects who have undergone refractive surgery (i.e., PRK, LASIK, LASEK, RK, or SMILE) in both eyes or cataract surgery in both eyes, with or without refractive enhancement in one or both eyes, ≥4 months prior to Screening Visit and experiencing persistent ocular surface pain since the surgery, and have been seen by an ophthalmologist or optometrist at least once with complaint of continued ocular pain since surgery.
  • Subjects who demonstrate a ≥ 60% reduction in ocular pain within 5 minutes after instillation of a single topical ocular anesthetic drop at Screening Visit.

At Baseline

  • Subjects with an average pain severity VAS score of ≥ 30 mm based on Daily eDiary for the last 7 days prior to Baseline Visit.
  • Subjects who have reported pain severity >10 mm based on Daily eDiary for > 50% of the days of the observational period (Screening)

Key Exclusion Criteria:

  • Use of nerve growth factor eye drops within 14 days of the Screening Visit
  • Seasonal allergic conjunctivitis, or other acute or seasonal ocular diagnosis that are active at the time of Screening or would be active during the course of the study.
  • Any history of ocular herpes simplex virus or herpes zoster virus infection, or other severe ocular conditions such as graft versus host disease, Stevens-Johnson syndrome or sarcoidosis.
  • Presence of any ocular infection (bacterial, viral, or fungal) within 30 days prior to Screening.
  • Chronic topical ocular medications (ie. cyclosporine, lifitegrast) initiated <6 months prior to Screening Visit, or any anticipated change during the study.
  • Use of ocular or nasal corticosteroids within 30 days of Screening Visit.
  • Use of neuromodulatory medications (eg, gabapentin, pregabalin) or opioid use for non-ocular pain within 30 days of Screening Visit.
  • Chronic medications (both over the counter and prescription) that have not been stable for at least 30 days prior to Screening Visit, or any anticipated change in the chronic medication regimen.
  • Subjects requiring hospitalization within 6 months prior to screening for severe psychiatric disorders (e.g. psychosis, schizophrenia, mania, depression) or major psychiatric illness.

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): NCT04630158


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, California
Novartis Investigative Site Recruiting
Bakersfield, California, United States, 93309
Novartis Investigative Site Recruiting
Mission Hills, California, United States, 91345
Novartis Investigative Site Recruiting
Newport Beach, California, United States, 92660
Novartis Investigative Site Recruiting
Palo Alto, California, United States, 94303
Novartis Investigative Site Recruiting
San Diego, California, United States, 92122
United States, Florida
Novartis Investigative Site Recruiting
Coral Springs, Florida, United States, 33067
Novartis Investigative Site Recruiting
Fort Lauderdale, Florida, United States, 33309
Novartis Investigative Site Recruiting
Miami, Florida, United States, 33136
United States, Georgia
Novartis Investigative Site Recruiting
Atlanta, Georgia, United States, 30339
United States, Maryland
Novartis Investigative Site Recruiting
Baltimore, Maryland, United States, 21201
United States, Michigan
Novartis Investigative Site Recruiting
Ann Arbor, Michigan, United States, 48105
United States, Missouri
Novartis Investigative Site Recruiting
Kansas City, Missouri, United States, 64155
United States, North Carolina
Novartis Investigative Site Recruiting
Durham, North Carolina, United States, 27710
United States, North Dakota
Novartis Investigative Site Recruiting
Fargo, North Dakota, United States, 58103
United States, Oklahoma
Novartis Investigative Site Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Novartis Investigative Site Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Novartis Investigative Site Recruiting
Chattanooga, Tennessee, United States, 37411
Novartis Investigative Site Recruiting
Maryville, Tennessee, United States, 37803
Novartis Investigative Site Recruiting
Memphis, Tennessee, United States, 38119
Novartis Investigative Site Recruiting
Nashville, Tennessee, United States, 37215
Novartis Investigative Site Recruiting
Smyrna, Tennessee, United States, 37167
United States, Texas
Novartis Investigative Site Recruiting
Bellaire, Texas, United States, 77401
Novartis Investigative Site Recruiting
Houston, Texas, United States, 77025
Novartis Investigative Site Recruiting
Houston, Texas, United States, 77030
Novartis Investigative Site Recruiting
San Antonio, Texas, United States, 78240
United States, Utah
Novartis Investigative Site Recruiting
Salt Lake City, Utah, United States, 84117
United States, Virginia
Novartis Investigative Site Recruiting
Lynchburg, Virginia, United States, 24502
United States, Washington
Novartis Investigative Site Recruiting
Renton, Washington, United States, 98057
Novartis Investigative Site Recruiting
Seattle, Washington, United States, 98119
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04630158    
Other Study ID Numbers: CSAF312B12201
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: December 28, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

URL: https://www.clinicalstudydatarequest.com/

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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 ):
Eye pain
Dry eye like symptoms
Ocular surface pain
Corneal induced chronic pain
neuropathic eye pain
post-operative corneal induced chronic pain
CICP
corneal
corneal pain
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions