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| Name | Class |
|---|---|
| Finnsusp Ltd. | INDUSTRY |
| 4Pharma Ltd. | INDUSTRY |
| Business Finland | OTHER |
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The study evaluates the safety, ocular tolerability and efficacy of emulsion eye drops with sacha inchi seed oil, trehalose and hyaluronic acid in the treatment of moderate or severe dry eye in adult patients. The investigative device is studied in comparison with control eye drops containing hyaluronic acid for up to 30 days.
According to the current view on dry eye disease, tear film instability, tear film hyperosmolarity, and ocular surface inflammation and damage are identified as etiological factors. The first-line medicinal management options include ocular lubricants such as eye drops and sprays. Emulsion eye drops are a relatively recent entity among topical therapies with an intention to account for deficiencies in the outermost lipid layer of the tear film.
Piiloset Trehalose Emulsion Eye Drops was developed to target and restore the three main layers (mucin, aqueous, and lipid) of the tear film and to counteract the key etiological factors leading to dry eye. Hyaluronic acid and the oil component are intended to restore tear film instability, the hypo-osmolar composition and trehalose as an osmoprotectant are intended to protect the ocular epithelium against hyperosmolarity, and ocular surface inflammation and cellular damage are prevented by the cytoprotective and/or anti-oxidative action of hyaluronic acid, trehalose, and sacha inchi oil components. Additional water binding in the tear film is provided by hyaluronic acid, trehalose, and glycerol. Lubricating the ocular surface by high-molecular-weight hyaluronic acid will extend the precorneal retention time. Adjustments made to certain physical and chemical parameters in the formulation are anticipated to improve tear film spreading and adhesion. The optically clear o/w emulsion formulation is free of preservatives, materials of animal origin, phosphates, or alcohol. The combined action of the individual components is expected to produce clinically relevant mitigation of the signs and symptoms of dry eye.
The study comprises three Parts with scheduled visits on Day 1 (all Parts) and on end-of-study date (Parts 2 and 3) to the study centre. Each study subject will participate in no more than one Part of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emulsion Eye Drops | Experimental | Daily treatment with Piiloset Trehalose Emulsion Eye Drops |
|
| Control Eye Drops | Active Comparator | Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piiloset Trehalose Emulsion Eye Drops | Device | Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops 3 times daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline OSDI | Ocular Surface Disease Index (OSDI) is a questionnaire consisting of 12 questions subdivided into 3 subscales for measuring the frequency of dry eye symptoms, vision-related quality of life and environmental triggers during the previous week. Answers to each question are on a scale of 0 (None of the time) to 4 (All of the time). Both total OSDI and its subscale scores are on a scale of 0 to 100, calculated as follows: score = (sum of scores for questions answered/number of questions answered) x 25. Higher scores represent greater disability. | From baseline to Day 30 (Part 3) |
| Change From Baseline Tear Osmolarity | Instrumental assay of tear fluid osmolarity (mOsm/L) | From baseline to Day 30 (Part 3) |
| Change From Baseline TBUT | Tear film break-up time (TBUT) (s) | From baseline to Day 30 (Part 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Blink Rate | Measurement of spontaneous eyelid blinks per minute | From baseline to Day 30 (Part 3) |
| Change From Baseline Ocular Protection Index (OPI) | OPI is the ratio of TBUT/IBI (IBI, interblink interval calculated from blink rate). An OPI value >1 indicates that TBUT (s) exceeds IBI (s) and that the ocular surface is mostly tear-film protected, because tear film break-ups do not take place within spontaneous blink cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Visual Acuity | Best corrected visual acuity (ETDRS charts 1 & 2, 2000 series) | From baseline to Day 30 (Part 3) |
| Change From Baseline Conjunctival Redness | Conjunctival redness score is assessed on an ordinal scale of 0 to 4 (IER grading scale): 0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness. |
Inclusion Criteria:
Ability and willingness to give informed written consent prior to any screening procedure after explanation of the nature and possible consequences of the study.
Age between 18 and 80 years.
At least two the following conditions (A and B):
A. Symptomatic dry eye with OSDI score ≥20. AND B1. Tear film break-up time (TBUT) <10 seconds. OR B2. Positive ocular (corneal and conjunctival) staining pattern
Body weight at least 45 kg.
Under stable topical and/or systemic therapy for at least 4 weeks before the study procedures and apparent ability and willingness to abstain from other therapies until completion of the study period.
Ability and willingness to self-administer eye drops.
Ability and willingness to understand and fill in the OSDI questionnaire.
Ability and willingness to comply with the study protocol and other study-related procedures.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kai Kaarniranta, Professor | Kuopio University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Kuopio University Hospital | Kuopio | FI-70200 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31579987 | Result | Laihia J, Jarvinen R, Wylegala E, Kaarniranta K. Disease aetiology-based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple-masked and active-controlled clinical trial. Acta Ophthalmol. 2020 May;98(3):244-254. doi: 10.1111/aos.14252. Epub 2019 Oct 3. |
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The study comprised three sequential parts. Parts 1 to 3 involved different participants each, thus no participant flow between parts (or periods) took place.
| ID | Title | Description |
|---|---|---|
| FG000 | Emulsion Eye Drops | Daily treatment with Piiloset Trehalose Emulsion Eye Drops Piiloset Trehalose Emulsion Eye Drops: Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops
|
| FG001 | Control Eye Drops | Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device) Control Eye Drops: Topical application of preservative-free multidose Hyaluronic Acid Eye Drops
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 |
| |||||||||||||
| Part 2 |
| |||||||||||||
| Part 3 |
|
Part 3: 52 eyes of 26 pts treated with Emulsion Eye Drops and 52 eyes of 26 pts treated with Control Eye Drops.
Results are reported for Part 3 only.
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| ID | Title | Description |
|---|---|---|
| BG000 | Emulsion Eye Drops | Daily treatment with Piiloset Trehalose Emulsion Eye Drops Results are reported for Part 3 only: Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days |
| BG001 | Control Eye Drops |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline OSDI | Ocular Surface Disease Index (OSDI) is a questionnaire consisting of 12 questions subdivided into 3 subscales for measuring the frequency of dry eye symptoms, vision-related quality of life and environmental triggers during the previous week. Answers to each question are on a scale of 0 (None of the time) to 4 (All of the time). Both total OSDI and its subscale scores are on a scale of 0 to 100, calculated as follows: score = (sum of scores for questions answered/number of questions answered) x 25. Higher scores represent greater disability. | Intent-to-treat (ITT) dataset | Posted | Mean | Standard Deviation | units on a scale | From baseline to Day 30 (Part 3) |
|
Part 1: 1 day; Part 2: 10 days; Part 3: 30 days
ADE (adverse device effect); AE (adverse event); SADE (serious adverse device effect); SAE (serious adverse event); USADE (unanticipated serious adverse device effect)
Total Number of Participants at Risk (safety population); Emulsion Eye Drops: 3 + 9 + 26 = 38 participants; Control Eye Drops: 0 + 9 + 26 = 35 participants.
Adverse events were collected throughout the study during visits to study site, in study diaries, and from direct contacts to study personnel between visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Emulsion Eye Drops | Daily treatment with Piiloset Trehalose Emulsion Eye Drops Adverse events are reported for the safety population in all parts of the study, including all randomized subjects who received Piiloset Trehalose Emulsion Eye Drops at least once and from whom at least one safety measurement was obtained after randomization. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AE (adverse event) | Skin and subcutaneous tissue disorders | EN ISO 14155:2011 | Systematic Assessment | Small cutaneous papules all over the body, judged by the Investigator to be unrelated to study treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jarmo Laihia, Manager of Clinical & Formulation Development | Finnsusp Ltd. | 358 50 377 1212 | jarmo.laihia@piiloset.fi |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 6, 2018 | Nov 20, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 6, 2018 | Nov 20, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D008224 | Lymphoma, Follicular |
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
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Part 1. Piiloset Trehalose Emulsion Eye Drop is administered on the worst eye four times during office hours of one day at the study centre.
Part 2. Piiloset Trehalose Emulsion Eye Drop is self-administered on a randomized eye and the control eye drops on the contralateral eye three times a day for 10 days in a double-blinded fashion.
Part 3. Either Piiloset Trehalose Emulsion Eye Drop or the control eye drops are self-administered on both eyes three times a day for 30 days in a randomized and double-blinded fashion.
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| Control Eye Drops | Device | Topical application of preservative-free multidose Hyaluronic Acid Eye Drops 3 times daily |
|
| From baseline to Day 30 (Part 3) |
| Change From Baseline Corneal Staining | Corneal staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining. | From baseline to Day 30 (Part 3) |
| Change From Baseline Conjunctival (Temporal) Staining | Conjunctival staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining. | From baseline to Day 30 (Part 3) |
| Change From Baseline Conjunctival (Nasal) Staining | Conjunctival staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining. | From baseline to Day 30 (Part 3) |
| From baseline to Day 30 (Part 3) |
| Change From Baseline Lid Redness | Eyelid redness score is assessed on an ordinal scale of 0 to 4 (IER grading scale): 0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness. | From baseline to Day 30 (Part 3) |
| Change From Baseline Intraocular Pressure | Intraocular pressure measured using Goldmann applanation tonometry (mmHg) | From baseline to Day 30 (Part 3) |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device) Results are reported for Part 3 only: Topical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Weight | Mean | Standard Deviation | kg |
|
| Ocular Surface Disease Index (OSDI) | Ocular Surface Disease Index (OSDI) is a questionnaire consisting of 12 questions subdivided into 3 subscales for measuring the frequency of dry eye symptoms, vision-related quality of life and environmental triggers during the previous week. Answers to each question are on a scale of 0 (None of the time) to 4 (All of the time). Both total OSDI and its subscale scores are on a scale of 0 to 100, calculated as follows: score = (sum of scores for questions answered/number of questions answered) x 25. Higher scores represent greater disability. | Mean | Standard Deviation | units on a scale |
|
| Tear Break-Up Time (TBUT) | Mean | Standard Deviation | s |
|
| Tear osmolarity | Mean | Standard Deviation | mOsm/L |
|
| Blink rate | Measurement of spontaneous eyelid blinks per minute | Mean | Standard Deviation | Blinks/min |
|
| Ocular protection index (OPI) | Ocular protection index (OPI) is the ratio of TBUT/IBI (IBI, interblink interval calculated from blink rate). An OPI value >1 indicates that TBUT (s) exceeds IBI (s) and that the ocular surface is mostly tear-film protected, because tear film break-ups do not take place within spontaneous blink cycles. | Mean | Standard Deviation | ratio |
|
| Corneal staining | Corneal staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining. | Mean | Standard Deviation | score on a scale |
|
| Conjunctival staining (temporal) | Conjunctival staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining. | Mean | Standard Deviation | score on a scale |
|
| Conjunctival staining (nasal) | Conjunctival staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining. | Mean | Standard Deviation | score on a scale |
|
| Conjunctival redness | Conjunctival redness score is assessed on an ordinal scale of 0 to 4 (Institute for Eye Research (IER) grading scale): 0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness. | Mean | Standard Deviation | score on a scale |
|
| Lid redness | Eyelid redness score is assessed on an ordinal scale of 0 to 4 (Institute for Eye Research (IER) grading scale): 0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness. | Mean | Standard Deviation | score on a scale |
|
| Intraocular pressure | Mean | Standard Deviation | mmHg (Goldmann tonometer) |
|
| Ocular surgery, trauma, refractive laser vision correction | Count of Participants | Participants |
|
| Eye infection | Count of Participants | Participants |
|
| Allergy | Count of Participants | Participants |
|
| Current or planned pregnancy and nursing | Count of Participants | Participants |
|
| OG001 | Control Eye Drops | Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device) Results are reported for Part 3 only: Topical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days |
|
|
|
| Primary | Change From Baseline Tear Osmolarity | Instrumental assay of tear fluid osmolarity (mOsm/L) | Intent-to-treat (ITT) dataset | Posted | Mean | Standard Deviation | mOsm/L | From baseline to Day 30 (Part 3) |
|
|
|
|
| Primary | Change From Baseline TBUT | Tear film break-up time (TBUT) (s) | Intent-to-treat (ITT) dataset | Posted | Mean | Standard Deviation | s | From baseline to Day 30 (Part 3) |
|
|
|
|
| Secondary | Change From Baseline Blink Rate | Measurement of spontaneous eyelid blinks per minute | Intent-to-treat (ITT) dataset | Posted | Mean | Standard Deviation | Blinks/min | From baseline to Day 30 (Part 3) |
|
|
|
|
| Secondary | Change From Baseline Ocular Protection Index (OPI) | OPI is the ratio of TBUT/IBI (IBI, interblink interval calculated from blink rate). An OPI value >1 indicates that TBUT (s) exceeds IBI (s) and that the ocular surface is mostly tear-film protected, because tear film break-ups do not take place within spontaneous blink cycles. | Intent-to-treat (ITT) dataset | Posted | Mean | Standard Deviation | ratio | From baseline to Day 30 (Part 3) |
|
|
|
|
| Secondary | Change From Baseline Corneal Staining | Corneal staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining. | Per-protocol (PP) dataset | Posted | Mean | Standard Deviation | score on a scale | From baseline to Day 30 (Part 3) |
|
|
|
|
| Secondary | Change From Baseline Conjunctival (Temporal) Staining | Conjunctival staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining. | Per-protocol (PP) dataset | Posted | Mean | Standard Deviation | score on a scale | From baseline to Day 30 (Part 3) |
|
|
|
|
| Secondary | Change From Baseline Conjunctival (Nasal) Staining | Conjunctival staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining. | Per-protocol (PP) dataset | Posted | Mean | Standard Deviation | score on a scale | From baseline to Day 30 (Part 3) |
|
|
|
|
| Other Pre-specified | Change From Baseline Visual Acuity | Best corrected visual acuity (ETDRS charts 1 & 2, 2000 series) | Safety dataset | Posted | Mean | Standard Deviation | logMAR chart log units | From baseline to Day 30 (Part 3) |
|
|
|
| Other Pre-specified | Change From Baseline Conjunctival Redness | Conjunctival redness score is assessed on an ordinal scale of 0 to 4 (IER grading scale): 0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness. | Safety dataset | Posted | Mean | Standard Deviation | score on a scale | From baseline to Day 30 (Part 3) |
|
|
|
|
| Other Pre-specified | Change From Baseline Lid Redness | Eyelid redness score is assessed on an ordinal scale of 0 to 4 (IER grading scale): 0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness. | Safety dataset | Posted | Mean | Standard Deviation | score on a scale | From baseline to Day 30 (Part 3) |
|
|
|
|
| Other Pre-specified | Change From Baseline Intraocular Pressure | Intraocular pressure measured using Goldmann applanation tonometry (mmHg) | Safety dataset | Posted | Mean | Standard Deviation | mmHg | From baseline to Day 30 (Part 3) |
|
|
|
| Post-Hoc | Change From Baseline Tear Osmolarity in Hyperosmolar Participants | Instrumental assay of tear fluid osmolarity (mOsm/L) in a hyperosmolar subgroup of participants (mean of eyes ≥308 mOsm/L) | ITT population with hyperosmolar tears (mean of eyes ≥308 mOsm/L) | Posted | Mean | Standard Deviation | mOsm/L | From baseline to Day 30 (Part 3) |
|
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 1 |
| 38 |
| EG001 | Control Eye Drops | Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device) Adverse events are reported for the safety population in all parts of the study, including all randomized subjects who received Hyaluronic Acid Eye Drops at least once and from whom at least one safety measurement was obtained after randomization. | 0 | 35 | 0 | 35 | 0 | 35 |
|
The disclosure restrictions on the PI are that the sponsor can review results communications 30 days prior to planned date of public release. If public release of information in communications may jeopardize protecting sponsor's immaterial rights, the sponsor can additionally embargo the communications for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D014947 | Wounds and Injuries |
Within-group change from baseline
| ANOVA |
| 0.2098 |
A two-sided p-value less than 0.05 was considered statistically significant. |
| Mean Difference (Final Values) |
| -4.7500 |
| 2-Sided |
| 95 |
| -12.2593 |
| 2.7593 |
| Other |
| Within-group change from baseline | ANOVA | 0.6381 | A two-sided p-value less than 0.05 was considered statistically significant. | Mean Difference (Final Values) | -1.7692 | 2-Sided | 95 | -9.2785 | 5.7401 | Other |
Within-group change from baseline
| ANOVA |
| 0.0025 |
A two-sided p-value less than 0.05 was considered statistically significant. |
| Mean Difference (Final Values) |
| 1.7115 |
| 2-Sided |
| 95 |
| 0.6330 |
| 2.7901 |
| Other |
| Within-group change from baseline | ANOVA | 0.1134 | A two-sided p-value less than 0.05 was considered statistically significant. | Mean Difference (Final Values) | 0.8654 | 2-Sided | 95 | -0.2132 | 1.9440 | Other |
Within-group change from baseline
| ANOVA |
| 0.9918 |
A two-sided p-value less than 0.05 was considered statistically significant. |
| Mean Difference (Final Values) |
| 0.01923 |
| 2-Sided |
| 95 |
| -3.7105 |
| 3.7490 |
| Other |
| Within-group change from baseline | ANOVA | 0.2516 | A two-sided p-value less than 0.05 was considered statistically significant. | Mean Difference (Final Values) | -2.1538 | 2-Sided | 95 | -5.8836 | 1.5759 | Other |
Within-group change from baseline
| ANOVA |
| 0.0026 |
A two-sided p-value less than 0.05 was considered statistically significant. |
| Mean Difference (Final Values) |
| 0.5596 |
| 2-Sided |
| 95 |
| 0.2046 |
| 0.9146 |
| Other |
| Within-group change from baseline | ANOVA | 0.7770 | A two-sided p-value less than 0.05 was considered statistically significant. | Mean Difference (Final Values) | 0.05032 | 2-Sided | 95 | -0.3047 | 0.4053 | Other |
| Wilcoxon rank sum test |
| 0.014 |
A two-sided p-value less than 0.05 was considered statistically significant. |
| Other |
| Within-group change from baseline | Wilcoxon rank sum test | 0.070 | A two-sided p-value less than 0.05 was considered statistically significant. | Other |
| Wilcoxon rank sum test |
| 0.119 |
A two-sided p-value less than 0.05 was considered statistically significant. |
| Other |
| Within-group change from baseline | Wilcoxon rank sum test | 0.900 | A two-sided p-value less than 0.05 was considered statistically significant. | Other |
| Wilcoxon rank sum test |
| 0.043 |
A two-sided p-value less than 0.05 was considered statistically significant. |
| Other |
| Within-group change from baseline | Wilcoxon rank sum test | 0.442 | A two-sided p-value less than 0.05 was considered statistically significant. | Other |
| Wilcoxon rank sum test |
| 0.001 |
A two-sided p-value less than 0.05 was considered statistically significant. |
| Other |
| Within-group change from baseline | Wilcoxon rank sum test | 0.065 | A two-sided p-value less than 0.05 was considered statistically significant. | Other |
| Wilcoxon rank sum test |
| 0.012 |
A two-sided p-value less than 0.05 was considered statistically significant. |
| Other |
| Within-group change from baseline | Wilcoxon rank sum test | >0.05 | A two-sided p-value less than 0.05 was considered statistically significant. | Other |
Within-group change from baseline
| ANOVA |
| 0.0038 |
A two-sided p-value less than 0.05 was considered statistically significant. |
| Mean Difference (Final Values) |
| -17.0625 |
| 2-Sided |
| 95 |
| -27.9280 |
| -6.1970 |
| Other |
| Within-group change from baseline | ANOVA | 0.0011 | A two-sided p-value less than 0.05 was considered statistically significant. | Mean Difference (Final Values) | -15.0714 | 2-Sided | 95 | -23.2850 | -6.8579 | Other |