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Sections: Correlations,
Clinical Trials, and HPO
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Navigate: Correlations HPO
There are 2 clinical trials
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
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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: Change of Intraocular pressure at T0 vs final assessment.
Measure: Incidence of change in the Intraocular pressure Time: 8 weeksDescription: 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 weeksDescription: 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 weeksDescription: Treatment adherence assessed by the patient at any study time-point (number of days of product usage).
Measure: Treatment adherence (total days) Time: 8 weeksThis 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
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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: Change of Intraocular pressure at T0 vs final assessment.
Measure: Incidence of change in the Intraocular pressure Time: 8 weeksDescription: 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 weeksDescription: 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 weeksDescription: Treatment adherence assessed by the patient at any study time-point (number of days of product usage).
Measure: Treatment adherence (total days) Time: 8 weeksAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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.
Drug Reports MeSH Reports HPO Reports