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Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Viral Conjunctivitis

Primary Purpose

Adenoviral Conjunctivitis

Status
Recruiting
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
IVIEW-1201
Placebo
Sponsored by
IVIEW Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenoviral Conjunctivitis focused on measuring IVIEW-1201, Adenoviral Conjunctivitis

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. An understanding, ability, and willingness to fully comply with study procedures and restrictions.
  2. Ability to voluntarily provide written, signed, and dated to participate in the study.
  3. Subjects of age 15 and over at Visit 1.
  4. Have a positive AdenoPlus® test at Visit 1 in at least 1 eye.
  5. Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye (the same eye as the AdenoPlus positive eye) confirmed by the presence of the following minimal clinical signs and symptoms in that same eye:

    • Reported presence of signs and/or symptoms of adenoviral conjunctivitis for ≤ 3 days prior to Visit 1
    • Bulbar conjunctival injection: a grade of >=1 on 0-4 scale of Bulbar Conjunctival Injection Scale
    • Watery conjunctival discharge: a grade of >=1 (mild) on a 0-3 Watery Conjunctival Discharge Scale
  6. Be willing to discontinue contact lens wear for the duration of the study.
  7. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.

Exclusion Criteria:

Subjects are excluded from the study if any of the following exclusion criteria are met.

  1. Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigator's discretion.
  2. Current or relevant history of physical or psychiatric illness, any medical disorder that may make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
  3. Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
  4. Prior enrollment in IVIEW-1201 clinical study.
  5. Subjects who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
  6. Have a history of ocular surgical intervention within ≤ 6 months prior to Visit 1 or planned for the period of the study.
  7. Have a preplanned overnight hospitalization during the period of the study.
  8. Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis.
  9. Have presence of corneal subepithelial infiltrates at Visit 1
  10. Have at enrollment or within ≤30 days of Visit 1, a clinical presentation more consistent with the diagnosis of ocular allergy, toxic conjunctivitis, or non-adenoviral ocular infection (eg, bacterial, fungal, acanthamoebae, other or parasitic).
  11. Age under 15.
  12. Prisoner.
  13. Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
  14. Presence of any significant ophthalmic condition (eg, Retinopathy of Prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study variables.
  15. Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect or any significant corneal opacity at Visit 1.
  16. Presence of significant, active condition in the posterior segment which requires invasive treatment (eg, intravitreal treatment with vascular endothelial growth factor (VEGF) inhibitors or corticosteroids) and may progress during the study participation period.
  17. Have used any topical ocular or systemic anti-viral or antibiotics within <= 7 days of enrollment.
  18. Have used any topical ocular NSAIDs within <=1 day of enrollment.
  19. Have used any topical ophthalmic steroids in the last <=14 days.
  20. Have used any systemic corticosteroid agents within <=14 days of Day 1. Stable (initiated ≥30 days prior to enrollment) use of inhaled and nasal corticosteroids is allowed, given no anticipated change in dose for the duration of the study. Topical dermal steroids are allowed except in the peri-ocular area.
  21. Have used non-corticosteroid immunosuppressive agents within <=14 days of Day 1, oral or topical or both.
  22. Have used any topical ophthalmic products, including tear substitutes, and over-the-counter preparations such as lid scrubs, within 2 hours of Visit 1 and be unable to discontinue all topical ophthalmic products for the duration of the study. Use of hot or cold compresses is also not permitted during the study.
  23. Have any significant ocular disease (eg, Sjogren's syndrome) or any uncontrolled systemic disease or debilitating disease (eg, cardiovascular disease, hypertension, sexually transmitted diseases/infections, diabetes or cystic fibrosis), that may affect the study parameters, per Investigator's discretion.
  24. Any known history of immunodeficiency disorder or known active conditions predisposing to immunodeficiency, such as human immunodeficiency virus, hepatitis B or C, evidence of active hepatitis A (antihepatitis A virus immunoglobulin M), or organ or bone marrow transplantation.
  25. Within 30 days prior to the first dose of investigational product:

    1. Have used an investigational product or device, or
    2. Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this IVIEW-sponsored study.
  26. Pregnant women confirmed with dipstick urine pregnancy testing at Screening and at the final visit.

Sites / Locations

  • Disha Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

IVIEW-1201; four times per day (QID) for 7 days

Placebo; four times per day (QID) for 7 days

Outcomes

Primary Outcome Measures

Clinical resolution by assessment of bulbar conjunctival injection and watery conjunctival discharge
Proportion of subjects achieving clinical resolution (zero for conjunctival injection and discharge)

Secondary Outcome Measures

Viral Eradication
Proportion of subjects with negative cell culture-immunofluorescence assay (CC-IFA)

Full Information

First Posted
November 14, 2018
Last Updated
March 15, 2023
Sponsor
IVIEW Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03749317
Brief Title
Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Viral Conjunctivitis
Official Title
A Double-Masked, Placebo-Controlled, Randomized, Phase II Clinical Trial To Assess The Efficacy Of IVIEW-1201 In The Treatment Of Acute Adenoviral Conjunctivitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IVIEW Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A Phase 2, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of IVIEW-1201 (1.0% Povidone-Iodine) Gel Forming Ophthalmic Solution Compared to Placebo in the Treatment of Adenoviral Conjunctivitis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoviral Conjunctivitis
Keywords
IVIEW-1201, Adenoviral Conjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
IVIEW-1201; four times per day (QID) for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo; four times per day (QID) for 7 days
Intervention Type
Drug
Intervention Name(s)
IVIEW-1201
Other Intervention Name(s)
Treatment Arm
Intervention Description
IVIEW-1201; QID; one drop per eye, four times per day (QID) for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Treatment Arm
Intervention Description
Placebo drug; QID; one drop per eye, four times per day (QID) for 7 days
Primary Outcome Measure Information:
Title
Clinical resolution by assessment of bulbar conjunctival injection and watery conjunctival discharge
Description
Proportion of subjects achieving clinical resolution (zero for conjunctival injection and discharge)
Time Frame
Day 6 +/- 1 Day
Secondary Outcome Measure Information:
Title
Viral Eradication
Description
Proportion of subjects with negative cell culture-immunofluorescence assay (CC-IFA)
Time Frame
Day 6 +/- 1 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: An understanding, ability, and willingness to fully comply with study procedures and restrictions. Ability to voluntarily provide written, signed, and dated to participate in the study. Subjects of age 15 and over at Visit 1. Have a positive AdenoPlus® test at Visit 1 in at least 1 eye. Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye (the same eye as the AdenoPlus positive eye) confirmed by the presence of the following minimal clinical signs and symptoms in that same eye: Reported presence of signs and/or symptoms of adenoviral conjunctivitis for ≤ 3 days prior to Visit 1 Bulbar conjunctival injection: a grade of >=1 on 0-4 scale of Bulbar Conjunctival Injection Scale Watery conjunctival discharge: a grade of >=1 (mild) on a 0-3 Watery Conjunctival Discharge Scale Be willing to discontinue contact lens wear for the duration of the study. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential. Exclusion Criteria: Subjects are excluded from the study if any of the following exclusion criteria are met. Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigator's discretion. Current or relevant history of physical or psychiatric illness, any medical disorder that may make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures. Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients. Prior enrollment in IVIEW-1201 clinical study. Subjects who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site. Have a history of ocular surgical intervention within ≤ 6 months prior to Visit 1 or planned for the period of the study. Have a preplanned overnight hospitalization during the period of the study. Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis. Have presence of corneal subepithelial infiltrates at Visit 1 Have at enrollment or within ≤30 days of Visit 1, a clinical presentation more consistent with the diagnosis of ocular allergy, toxic conjunctivitis, or non-adenoviral ocular infection (eg, bacterial, fungal, acanthamoebae, other or parasitic). Age under 15. Prisoner. Presence of nasolacrimal duct obstruction at Visit 1 (Day 1). Presence of any significant ophthalmic condition (eg, Retinopathy of Prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study variables. Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect or any significant corneal opacity at Visit 1. Presence of significant, active condition in the posterior segment which requires invasive treatment (eg, intravitreal treatment with vascular endothelial growth factor (VEGF) inhibitors or corticosteroids) and may progress during the study participation period. Have used any topical ocular or systemic anti-viral or antibiotics within <= 7 days of enrollment. Have used any topical ocular NSAIDs within <=1 day of enrollment. Have used any topical ophthalmic steroids in the last <=14 days. Have used any systemic corticosteroid agents within <=14 days of Day 1. Stable (initiated ≥30 days prior to enrollment) use of inhaled and nasal corticosteroids is allowed, given no anticipated change in dose for the duration of the study. Topical dermal steroids are allowed except in the peri-ocular area. Have used non-corticosteroid immunosuppressive agents within <=14 days of Day 1, oral or topical or both. Have used any topical ophthalmic products, including tear substitutes, and over-the-counter preparations such as lid scrubs, within 2 hours of Visit 1 and be unable to discontinue all topical ophthalmic products for the duration of the study. Use of hot or cold compresses is also not permitted during the study. Have any significant ocular disease (eg, Sjogren's syndrome) or any uncontrolled systemic disease or debilitating disease (eg, cardiovascular disease, hypertension, sexually transmitted diseases/infections, diabetes or cystic fibrosis), that may affect the study parameters, per Investigator's discretion. Any known history of immunodeficiency disorder or known active conditions predisposing to immunodeficiency, such as human immunodeficiency virus, hepatitis B or C, evidence of active hepatitis A (antihepatitis A virus immunoglobulin M), or organ or bone marrow transplantation. Within 30 days prior to the first dose of investigational product: Have used an investigational product or device, or Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this IVIEW-sponsored study. Pregnant women confirmed with dipstick urine pregnancy testing at Screening and at the final visit.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qi Zhu, MD
Phone
617-431-7479
Email
qzhu@iviewinc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis Mah, MD
Organizational Affiliation
Scripps Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qi Zhu, MD
Organizational Affiliation
IVIEW Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Disha Eye Hospital
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700120
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Parag Sarve
Phone
+91-9599466552
Email
parag@excellifesciences.com
First Name & Middle Initial & Last Name & Degree
Virender Sangwan, MD

12. IPD Sharing Statement

Learn more about this trial

Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Viral Conjunctivitis

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