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Effects of NOV03 on the Tear Film

Primary Purpose

Dry Eye Disease (DED)

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
instillation of NOV03
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease (DED)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: General/Ocular Inclusion Criteria 1. Will be at least 18 years of age at the time of consent. 2. Able to provide written voluntary informed consent. 3. Have a subject-reported history of DED in both eyes for at least 6 months prior to Visit 1. 4. Have Tear film break-up time (TFBUT) ≤5 sec at Visit Have Ocular Surface Disease Index (OSDI) ≥25 at Visit 1. Have an unanesthetized Schirmer's Test I ≥5 mm at Visit 1. Have Meibomian Gland Dysfunction (MGD) defined as total MGD score ≥ 3 (secretion of 5 central glands on lower eyelid will be evaluated, each will be scored from 0-3; 0 = normal, 1 = thick/yellow, whitish, particulate 2 = paste; 3 = none/occluded; total score will range from 0-15) at Visit 1. Have a total corneal fluorescein staining score of ≥2 and ≤11 (i.e. sum of inferior, superior, central, nasal, and temporal) according to the National Eye Institute (NEI) scale at Visit 1. Have at least one eye that satisfies all criteria for 4-8 above at Visit 1. Is able to fix his/her gaze for a minute, i.e. can see the fixation target and with no nystagmus Is able and willing to follow instructions, including participation in all trial assessments and visits. Exclusion Criteria: General/Ocular Exclusion Criteria Have any clinically significant ocular surface slit-lamp findings at Visit 1 and Visit 2 and/or in the opinion of the Investigator had any findings that may have interfered with trial parameters, including history of eye trauma history of Stevens-Johnson syndrome active blepharitis or lid margin inflammation DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency). abnormal lid anatomy that caused incomplete eyelid closure abnormal cornea shape (keratoconus) corneal epithelial defect or significant confluent staining or filaments history of herpetic keratitis. has a pterygium in either eye. ocular or periocular rosacea that in the judgement of the Investigator interfered with the trial Has used any topical ocular steroids treatments, prescription dry eye therapy including varenicline nasal spray, or topical anti-glaucoma medication within 60 days prior to Visit 1. Have had a LipiFlow procedure, intense pulse light procedure or any kind of other procedure affecting meibomian glands within 6 months prior to Visit 2. Have received or removed a permanent punctum plug within 3 months (6 months for dissolvable punctum plugs) prior to Visit 2. Have used any eye drops (prescription or artificial tears) and/or TrueTearTM device (intranasal tear neurostimulator) within 24 hours before Visit 2. Have active ocular allergies or ocular allergies that are expected to be active during the trial period. Have worn contact lenses within 1 month of Visit 1 or anticipate using contact lenses during the trial. Have undergone intraocular surgery or ocular laser surgery within the previous 6 months or had any planned ocular and/or lid surgeries over the trial period. Have an active ocular or systemic infection (bacterial, viral, or fungal), including fever requiring treatment with antibiotics. Is a woman who was pregnant, nursing or planning a pregnancy. Is a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception included: hormonal (oral, implantable, injectable, or transdermal contraceptives); mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom); intrauterine device; or surgical sterilization of partner. For non-sexually active females, abstinence could have been regarded as an adequate method of birth control; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial. Has an uncontrolled systemic disease in the opinion of the Investigator will interfere with the trial. Has a known allergy and/or sensitivity to the investigational drug. Has used any oral medications known to cause ocular drying (e.g., antihistamines, antidepressants, etc.) on a non-stable regimen within 1 month prior to Visit 1 or is expected to be unstable during the trial. Have taken isotretinoin (e.g. Accutane, Myorisan, Claravis, Amnesteem) within 6 months of Visit 1. Has corrected VA worse than or equal to logarithm of the minimum angle of resolution (LogMAR), +0.7 as assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) charts in both eyes at Visit 1. Is currently enrolled in an investigational drug or device study or had used an investigational drug or device within 60 days of Visit 2.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Perfluorohexyloctane

    Arm Description

    Outcomes

    Primary Outcome Measures

    Thickness of the mucus-aqueous tear film layer
    Thickness of the mucus-aqueous layer of the tear film, measured in nanometers
    Thinning rate of the mucus-aqueous tear film layer
    The rate of change in the thickness of the tear film mucus-aqueous layer, measured in nanometers/second

    Secondary Outcome Measures

    Full Information

    First Posted
    January 19, 2023
    Last Updated
    April 25, 2023
    Sponsor
    Bausch & Lomb Incorporated
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05723770
    Brief Title
    Effects of NOV03 on the Tear Film
    Official Title
    Effects of NOV03 on the Tear Film in Subjects With Dry Eye Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 3, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bausch & Lomb Incorporated

    4. Oversight

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

    5. Study Description

    Brief Summary
    Determine the effect of a single instillation of NOV03 on the thickness and evaporation rate of the mucus-aqueous layer of the tear film
    Detailed Description
    Characterize the effect of a single instillation of NOV03 on the lipid layer of the tear film

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Eye Disease (DED)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Model Description
    This pilot, open label, single-arm, single-center study will consist of 2 study visits in subjects with dry eye disease associated with MGD. A Screening Visit will occur to verify subjects are eligible to participate followed by an Assessment Visit to evaluate tear film parameters at baseline and over approx. 4 hours following a single instillation of NOV03
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Perfluorohexyloctane
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    instillation of NOV03
    Intervention Description
    This trial consists of 2 office visits over a period of approximately 2 weeks. At Visit 2, a designated clinical staff member or the investigator will instill 1 drop of NOV03 into each eye.
    Primary Outcome Measure Information:
    Title
    Thickness of the mucus-aqueous tear film layer
    Description
    Thickness of the mucus-aqueous layer of the tear film, measured in nanometers
    Time Frame
    over 4 hours following instillation of NOV03
    Title
    Thinning rate of the mucus-aqueous tear film layer
    Description
    The rate of change in the thickness of the tear film mucus-aqueous layer, measured in nanometers/second
    Time Frame
    over 4 hours following instillation of NOV03

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: General/Ocular Inclusion Criteria 1. Will be at least 18 years of age at the time of consent. 2. Able to provide written voluntary informed consent. 3. Have a subject-reported history of DED in both eyes for at least 6 months prior to Visit 1. 4. Have Tear film break-up time (TFBUT) ≤5 sec at Visit Have Ocular Surface Disease Index (OSDI) ≥25 at Visit 1. Have an unanesthetized Schirmer's Test I ≥5 mm at Visit 1. Have Meibomian Gland Dysfunction (MGD) defined as total MGD score ≥ 3 (secretion of 5 central glands on lower eyelid will be evaluated, each will be scored from 0-3; 0 = normal, 1 = thick/yellow, whitish, particulate 2 = paste; 3 = none/occluded; total score will range from 0-15) at Visit 1. Have a total corneal fluorescein staining score of ≥2 and ≤11 (i.e. sum of inferior, superior, central, nasal, and temporal) according to the National Eye Institute (NEI) scale at Visit 1. Have at least one eye that satisfies all criteria for 4-8 above at Visit 1. Is able to fix his/her gaze for a minute, i.e. can see the fixation target and with no nystagmus Is able and willing to follow instructions, including participation in all trial assessments and visits. Exclusion Criteria: General/Ocular Exclusion Criteria Have any clinically significant ocular surface slit-lamp findings at Visit 1 and Visit 2 and/or in the opinion of the Investigator had any findings that may have interfered with trial parameters, including history of eye trauma history of Stevens-Johnson syndrome active blepharitis or lid margin inflammation DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency). abnormal lid anatomy that caused incomplete eyelid closure abnormal cornea shape (keratoconus) corneal epithelial defect or significant confluent staining or filaments history of herpetic keratitis. has a pterygium in either eye. ocular or periocular rosacea that in the judgement of the Investigator interfered with the trial Has used any topical ocular steroids treatments, prescription dry eye therapy including varenicline nasal spray, or topical anti-glaucoma medication within 60 days prior to Visit 1. Have had a LipiFlow procedure, intense pulse light procedure or any kind of other procedure affecting meibomian glands within 6 months prior to Visit 2. Have received or removed a permanent punctum plug within 3 months (6 months for dissolvable punctum plugs) prior to Visit 2. Have used any eye drops (prescription or artificial tears) and/or TrueTearTM device (intranasal tear neurostimulator) within 24 hours before Visit 2. Have active ocular allergies or ocular allergies that are expected to be active during the trial period. Have worn contact lenses within 1 month of Visit 1 or anticipate using contact lenses during the trial. Have undergone intraocular surgery or ocular laser surgery within the previous 6 months or had any planned ocular and/or lid surgeries over the trial period. Have an active ocular or systemic infection (bacterial, viral, or fungal), including fever requiring treatment with antibiotics. Is a woman who was pregnant, nursing or planning a pregnancy. Is a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception included: hormonal (oral, implantable, injectable, or transdermal contraceptives); mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom); intrauterine device; or surgical sterilization of partner. For non-sexually active females, abstinence could have been regarded as an adequate method of birth control; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial. Has an uncontrolled systemic disease in the opinion of the Investigator will interfere with the trial. Has a known allergy and/or sensitivity to the investigational drug. Has used any oral medications known to cause ocular drying (e.g., antihistamines, antidepressants, etc.) on a non-stable regimen within 1 month prior to Visit 1 or is expected to be unstable during the trial. Have taken isotretinoin (e.g. Accutane, Myorisan, Claravis, Amnesteem) within 6 months of Visit 1. Has corrected VA worse than or equal to logarithm of the minimum angle of resolution (LogMAR), +0.7 as assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) charts in both eyes at Visit 1. Is currently enrolled in an investigational drug or device study or had used an investigational drug or device within 60 days of Visit 2.

    12. IPD Sharing Statement

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    Effects of NOV03 on the Tear Film

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