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  • HP:0001097: Keratoconjunctivitis sicca
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    HP:0001097: Keratoconjunctivitis sicca

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (1)


    Name (Synonyms) Correlation
    drug378 Artificial tear MDI - 101 Wiki 0.71

    Correlated MeSH Terms (4)


    Name (Synonyms) Correlation
    D015352 Dry Eye Syndromes NIH 0.71
    D007638 Keratoconjunctivitis Sicca NIH 0.71
    D005128 Eye Diseases NIH 0.41
    Name (Synonyms) Correlation
    D007249 Inflammation NIH 0.12

    Correlated HPO Terms (1)


    Name (Synonyms) Correlation
    HP:0000478 Abnormality of the eye HPO 0.41

    Clinical Trials

    Navigate: Correlations   HPO

    There are 2 clinical trials


    1 Pilot Study on Safety and Performance of an Artificial Tear Containing Arabinogalactan, Trehalose and Hyaluronic Acid in the Treatment of Dry Eye in Subjects With Inflammation of the Ocular Surface

    This is post-market study to evaluate the safety and efficacy of MDI - 101 a novel tear substitute for the treatment of dry eye (DE) in subjects with evidence of inflammation of the ocular surface. In particular, this study intends to evaluate, in a cohort of 25 patients, the anti-inflammatory properties of the product under study over a period of 10 weeks

    NCT04633863
    Conditions
    1. Dry Eye Disease
    Interventions
    1. Device: Artificial tear MDI - 101
    MeSH:Keratoconjunctivitis Sicca Dry Eye Syndromes Eye Diseases Inflammation
    HPO:Abnormality of the eye Keratoconjunctivitis sicca

    Primary Outcomes

    Description: Change of OSDI score versus baseline at any study time-point. The main goal of the study is to gather information about the efficacy, assessed by OSDI (Ocular Surface Disease Index) questionnaire, of artificial tear containing AG, trehalose and HA (MDI - 101) used in the treatment of symptoms of DE of various aetiology, with evidence of inflammation of the ocular surface. The OSDI score ranges from 0 (better outcome) to 100 (worst outcome)

    Measure: Efficacy - Ocular Surface Disease Index (OSDI)

    Time: 1 week - 2 weeks - 4 weeks - 6 weeks - 8 weeks

    Secondary Outcomes

    Description: Change of tear matrix metalloproteinase(MMP)-9 at T0 vs final assessment. The result of the MMP test could be NEGATIVE if the level of MMP-9 is < 40 ng/ml (better outcome) or POSITIVE if the level of MMP-9 is ≥ 40 ng/ml (worst outcome)

    Measure: Additional efficacy parameters: Matrix Metalloproteinase 9 (MMP-9)

    Time: 8 weeks

    Description: Change of Efron Grading Scales at T0 vs final assessment. The Efron grading scale range from 0 (cornea surface normale) to 4 (severe corneal damage)

    Measure: Additional Efficacy parameters: EFRON SCALE

    Time: 8 weeks

    Description: Change of Corneal and Conjunctival Staining at T0 vs final assessment. The Staining scale ranges from 0 (better outcome) to 3 (worst outcome)

    Measure: Additional Efficacy parameters: Corneal and Conjunctival Staining

    Time: 8 weeks

    Description: Change of NIBUT at T0 vs final assessment. The result of the Non-Invasive Break-Up Time (NIBUT) test could be >10 seconds (better outcome) or ≤10 seconds (worst outcome)

    Measure: Additional Efficacy parameters: NIBUT

    Time: 8 weeks

    Description: Change of Osmolarity at T0 vs final assessment. The higher the tear film osmolarity, the greater the severity of the ocular surface damage.

    Measure: Additional Efficacy parameters: Osmolarity

    Time: 8 weeks

    Description: Change of Ocular Protection Index (OPI) at T0 vs final assessment The principle of the test is that when BUT is shorter than the blink interval, the eyes are exposed to the risk of focal ocular surface damage.

    Measure: Additional Efficacy parameters: Ocular Protection Index

    Time: 8 weeks

    Description: Change of meniscometry at T0 vs final assessment. The lowest tear meniscus radius, the higher the severity of the ocular surface health

    Measure: Additional Efficacy parameters: meniscometry

    Time: 8 weeks

    Description: Safety Adverse Event (AE) experienced with the artificial tear assessed by the patient, before the ocular examination or reported by the patient at any time during the study.

    Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time: 8 weeks

    Description: Unaided and corrected visual acuity Snellen test will be performed to evaluate change in the unaided and corrected visual acuity at T0 vs final assessment.

    Measure: Incidence of change in the unaided and corrected visual acuity

    Time: 8 weeks

    Description: Change of Intraocular pressure at T0 vs final assessment.

    Measure: Incidence of change in the Intraocular pressure

    Time: 8 weeks

    Description: Treatment adherence assessed by the patient at any study time-point (number of instillations in the past 24 hours).

    Measure: Evaluation of the Tolerability Signs and symptoms of discomfort

    Time: 8 weeks

    Description: Treatment adherence assessed by the patient at any study time-point (number of instillations in the past 24 hours)

    Measure: Treatment adherence (24 hours)

    Time: 8 weeks

    Description: Treatment adherence assessed by the patient at any study time-point (number of days of product usage).

    Measure: Treatment adherence (total days)

    Time: 8 weeks
    2 Pilot Study on Safety and Performance of an Artificial Tear Containing Arabinogalactan, Trehalose and Hyaluronic Acid in the Treatment of Dry Eye in Subjects With Inflammation of the Ocular Surface

    This is post-market study to evaluate the safety and efficacy of MDI - 101 a novel tear substitute for the treatment of dry eye (DE) in subjects with evidence of inflammation of the ocular surface. In particular, this study intends to evaluate, in a cohort of 25 patients, the anti-inflammatory properties of the product under study over a period of 10 weeks

    NCT04633863
    Conditions
    1. Dry Eye Disease
    Interventions
    1. Device: Artificial tear MDI - 101
    MeSH:Keratoconjunctivitis Sicca Dry Eye Syndromes Eye Diseases Inflammation
    HPO:Abnormality of the eye Keratoconjunctivitis sicca

    Primary Outcomes

    Description: Change of OSDI score versus baseline at any study time-point. The main goal of the study is to gather information about the efficacy, assessed by OSDI (Ocular Surface Disease Index) questionnaire, of artificial tear containing AG, trehalose and HA (MDI - 101) used in the treatment of symptoms of DE of various aetiology, with evidence of inflammation of the ocular surface. The OSDI score ranges from 0 (better outcome) to 100 (worst outcome)

    Measure: Efficacy - Ocular Surface Disease Index (OSDI)

    Time: 1 week - 2 weeks - 4 weeks - 6 weeks - 8 weeks

    Secondary Outcomes

    Description: Change of tear matrix metalloproteinase(MMP)-9 at T0 vs final assessment. The result of the MMP test could be NEGATIVE if the level of MMP-9 is < 40 ng/ml (better outcome) or POSITIVE if the level of MMP-9 is ≥ 40 ng/ml (worst outcome)

    Measure: Additional efficacy parameters: Matrix Metalloproteinase 9 (MMP-9)

    Time: 8 weeks

    Description: Change of Efron Grading Scales at T0 vs final assessment. The Efron grading scale range from 0 (cornea surface normale) to 4 (severe corneal damage)

    Measure: Additional Efficacy parameters: EFRON SCALE

    Time: 8 weeks

    Description: Change of Corneal and Conjunctival Staining at T0 vs final assessment. The Staining scale ranges from 0 (better outcome) to 3 (worst outcome)

    Measure: Additional Efficacy parameters: Corneal and Conjunctival Staining

    Time: 8 weeks

    Description: Change of NIBUT at T0 vs final assessment. The result of the Non-Invasive Break-Up Time (NIBUT) test could be >10 seconds (better outcome) or ≤10 seconds (worst outcome)

    Measure: Additional Efficacy parameters: NIBUT

    Time: 8 weeks

    Description: Change of Osmolarity at T0 vs final assessment. The higher the tear film osmolarity, the greater the severity of the ocular surface damage.

    Measure: Additional Efficacy parameters: Osmolarity

    Time: 8 weeks

    Description: Change of Ocular Protection Index (OPI) at T0 vs final assessment The principle of the test is that when BUT is shorter than the blink interval, the eyes are exposed to the risk of focal ocular surface damage.

    Measure: Additional Efficacy parameters: Ocular Protection Index

    Time: 8 weeks

    Description: Change of meniscometry at T0 vs final assessment. The lowest tear meniscus radius, the higher the severity of the ocular surface health

    Measure: Additional Efficacy parameters: meniscometry

    Time: 8 weeks

    Description: Safety Adverse Event (AE) experienced with the artificial tear assessed by the patient, before the ocular examination or reported by the patient at any time during the study.

    Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time: 8 weeks

    Description: Unaided and corrected visual acuity Snellen test will be performed to evaluate change in the unaided and corrected visual acuity at T0 vs final assessment.

    Measure: Incidence of change in the unaided and corrected visual acuity

    Time: 8 weeks

    Description: Change of Intraocular pressure at T0 vs final assessment.

    Measure: Incidence of change in the Intraocular pressure

    Time: 8 weeks

    Description: Treatment adherence assessed by the patient at any study time-point (number of instillations in the past 24 hours).

    Measure: Evaluation of the Tolerability Signs and symptoms of discomfort

    Time: 8 weeks

    Description: Treatment adherence assessed by the patient at any study time-point (number of instillations in the past 24 hours)

    Measure: Treatment adherence (24 hours)

    Time: 8 weeks

    Description: Treatment adherence assessed by the patient at any study time-point (number of days of product usage).

    Measure: Treatment adherence (total days)

    Time: 8 weeks

    HPO Nodes


    Reports

    Data processed on December 13, 2020.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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