Dry Eye Syndrome
Conditions
Keywords
Lubricant Eye Drops, Moderate or Severe Dry Eye, Hyaluronic Acid, Trehalose, Disaccharides, Polysaccharides, Fatty Acids, Omega-3, Tears, Osmolar Concentration, Anterior Eye Segment, Severity of Illness Index
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPiiloset Trehalose Emulsion Eye Drops
Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops 3 times daily
DEVICEControl Eye Drops
Topical application of preservative-free multidose Hyaluronic Acid Eye Drops 3 times daily
Sponsors
Finnsusp Ltd.
4Pharma Ltd.
Business Finland
Kuopio University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Ability and willingness to give informed written consent prior to any screening procedure after explanation of the nature and possible consequences of the study. 2. Age between 18 and 80 years. 3. 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 4. Body weight at least 45 kg. 5. 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. 6. Ability and willingness to self-administer eye drops. 7. Ability and willingness to understand and fill in the OSDI questionnaire. 8. Ability and willingness to comply with the study protocol and other study-related procedures.
Exclusion criteria
1. History of ocular surgery, trauma, or refractive laser vision correction procedure less than 3 months earlier. 2. Evidence of acute or chronic infection in the cornea or conjunctiva. 3. Diagnosis of Sjögren's syndrome. 4. Unwillingness or apparent disability to discontinue contact lens use during study period and at least one week before the first dosing day. 5. Current ocular allergy symptoms. 6. Known allergy to any constituent of the trehalose emulsion eye drops or control eye drops. 7. Currently pregnant, nursing or planning to become pregnant before completion of the study period. 8. Any other condition that may, in the Investigator's opinion, jeopardize the safety or availability of the subject or adherence to the study protocol or may interfere with the interpretation of the results and would thus make the subject inappropriate for entry in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline OSDI | From baseline to Day 30 (Part 3) | 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. |
| Change From Baseline TBUT | From baseline to Day 30 (Part 3) | Tear film break-up time (TBUT) (s) |
| Change From Baseline Tear Osmolarity | From baseline to Day 30 (Part 3) | Instrumental assay of tear fluid osmolarity (mOsm/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Corneal Staining | From baseline to Day 30 (Part 3) | 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. |
| Change From Baseline Blink Rate | From baseline to Day 30 (Part 3) | Measurement of spontaneous eyelid blinks per minute |
| Change From Baseline Ocular Protection Index (OPI) | From baseline to Day 30 (Part 3) | 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. |
| Change From Baseline Conjunctival (Temporal) Staining | From baseline to Day 30 (Part 3) | 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. |
| Change From Baseline Conjunctival (Nasal) Staining | From baseline to Day 30 (Part 3) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Conjunctival Redness | From baseline to Day 30 (Part 3) | 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. |
| Change From Baseline Intraocular Pressure | From baseline to Day 30 (Part 3) | Intraocular pressure measured using Goldmann applanation tonometry (mmHg) |
| Change From Baseline Visual Acuity | From baseline to Day 30 (Part 3) | Best corrected visual acuity (ETDRS charts 1 & 2, 2000 series) |
| Change From Baseline Lid Redness | From baseline to Day 30 (Part 3) | 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. |
Countries
Finland
Participant flow
Recruitment details
The study comprised three sequential parts. Parts 1 to 3 involved different participants each, thus no participant flow between parts (or periods) took place.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| 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 | 26 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Part 3 | Other | 1 | 1 |
| Part 3 | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Control Eye Drops | Total | Emulsion Eye Drops |
|---|---|---|---|
| Age, Continuous | 51.5 years STANDARD_DEVIATION 11.4 | 53.3 years STANDARD_DEVIATION 12.6 | 55.1 years STANDARD_DEVIATION 13.8 |
| Allergy | 0 Participants | 0 Participants | 0 Participants |
| Blink rate | 22.27 Blinks/min STANDARD_DEVIATION 12.93 | 20.22 Blinks/min STANDARD_DEVIATION 12.28 | 18.17 Blinks/min STANDARD_DEVIATION 11.49 |
| Body Weight | 76.9 kg STANDARD_DEVIATION 15.8 | 76.0 kg STANDARD_DEVIATION 13.8 | 75.1 kg STANDARD_DEVIATION 11.7 |
| Conjunctival redness | 1.94 score on a scale STANDARD_DEVIATION 0.829 | 1.96 score on a scale STANDARD_DEVIATION 0.753 | 1.98 score on a scale STANDARD_DEVIATION 0.685 |
| Conjunctival staining (nasal) | 1.23 score on a scale STANDARD_DEVIATION 0.406 | 1.23 score on a scale STANDARD_DEVIATION 0.414 | 1.23 score on a scale STANDARD_DEVIATION 0.43 |
| Conjunctival staining (temporal) | 1.06 score on a scale STANDARD_DEVIATION 0.497 | 1.06 score on a scale STANDARD_DEVIATION 0.461 | 1.06 score on a scale STANDARD_DEVIATION 0.432 |
| Corneal staining | 1.21 score on a scale STANDARD_DEVIATION 0.603 | 1.29 score on a scale STANDARD_DEVIATION 0.703 | 1.37 score on a scale STANDARD_DEVIATION 0.794 |
| Current or planned pregnancy and nursing | 0 Participants | 0 Participants | 0 Participants |
| Eye infection | 0 Participants | 0 Participants | 0 Participants |
| Intraocular pressure | 15.69 mmHg (Goldmann tonometer) STANDARD_DEVIATION 2.558 | 15.31 mmHg (Goldmann tonometer) STANDARD_DEVIATION 2.364 | 14.92 mmHg (Goldmann tonometer) STANDARD_DEVIATION 2.134 |
| Lid redness | 1.29 score on a scale STANDARD_DEVIATION 0.724 | 1.29 score on a scale STANDARD_DEVIATION 0.73 | 1.29 score on a scale STANDARD_DEVIATION 0.751 |
| Ocular protection index (OPI) | 1.23 ratio STANDARD_DEVIATION 1.188 | 1.11 ratio STANDARD_DEVIATION 1.067 | 0.98 ratio STANDARD_DEVIATION 0.937 |
| Ocular Surface Disease Index (OSDI) | 45.6 units on a scale STANDARD_DEVIATION 11.3 | 46.9 units on a scale STANDARD_DEVIATION 11 | 48.1 units on a scale STANDARD_DEVIATION 10.8 |
| Ocular surgery, trauma, refractive laser vision correction | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Finland | 26 participants | 52 participants | 26 participants |
| Sex: Female, Male Female | 18 Participants | 36 Participants | 18 Participants |
| Sex: Female, Male Male | 8 Participants | 16 Participants | 8 Participants |
| Tear Break-Up Time (TBUT) | 3.46 s STANDARD_DEVIATION 2.04 | 3.40 s STANDARD_DEVIATION 2.33 | 3.35 s STANDARD_DEVIATION 2.62 |
| Tear osmolarity | 307.3 mOsm/L STANDARD_DEVIATION 12.4 | 305.6 mOsm/L STANDARD_DEVIATION 12.1 | 304.0 mOsm/L STANDARD_DEVIATION 11.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 35 |
| other Total, other adverse events | 1 / 38 | 0 / 35 |
| serious Total, serious adverse events | 0 / 38 | 0 / 35 |
Outcome results
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.
Time frame: From baseline to Day 30 (Part 3)
Population: Intent-to-treat (ITT) dataset
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emulsion Eye Drops | Change From Baseline OSDI | -24.64 units on a scale | Standard Deviation 16.186 |
| Control Eye Drops | Change From Baseline OSDI | -26.53 units on a scale | Standard Deviation 14.62 |
Comparison: Between-group comparison, change from baselinep-value: 0.66295% CI: [-6.7081, 10.4756]ANOVA
Comparison: Within-group change from baselinep-value: <0.000195% CI: [-30.7199, -18.5692]ANOVA
Comparison: Within-group change from baselinep-value: <0.000195% CI: [-32.6036, -20.4529]ANOVA
Primary
Change From Baseline TBUT
Tear film break-up time (TBUT) (s)
Time frame: From baseline to Day 30 (Part 3)
Population: Intent-to-treat (ITT) dataset
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emulsion Eye Drops | Change From Baseline TBUT | 1.71 s | Standard Deviation 3.424 |
| Control Eye Drops | Change From Baseline TBUT | 0.87 s | Standard Deviation 1.809 |
Comparison: Between-group comparison, change from baselinep-value: 0.27195% CI: [-0.6792, 2.3715]ANOVA
Comparison: Within-group change from baselinep-value: 0.002595% CI: [0.633, 2.7901]ANOVA
Comparison: Within-group change from baselinep-value: 0.113495% CI: [-0.2132, 1.944]ANOVA
Primary
Change From Baseline Tear Osmolarity
Instrumental assay of tear fluid osmolarity (mOsm/L)
Time frame: From baseline to Day 30 (Part 3)
Population: Intent-to-treat (ITT) dataset
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emulsion Eye Drops | Change From Baseline Tear Osmolarity | -4.75 mOsm/L | Standard Deviation 16.224 |
| Control Eye Drops | Change From Baseline Tear Osmolarity | -1.77 mOsm/L | Standard Deviation 21.531 |
Comparison: Between-group comparison, change from baselinep-value: 0.57595% CI: [-13.6005, 7.639]ANOVA
Comparison: Within-group change from baselinep-value: 0.209895% CI: [-12.2593, 2.7593]ANOVA
Comparison: Within-group change from baselinep-value: 0.638195% CI: [-9.2785, 5.7401]ANOVA
Secondary
Change From Baseline Blink Rate
Measurement of spontaneous eyelid blinks per minute
Time frame: From baseline to Day 30 (Part 3)
Population: Intent-to-treat (ITT) dataset
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emulsion Eye Drops | Change From Baseline Blink Rate | 0.02 Blinks/min | Standard Deviation 8.721 |
| Control Eye Drops | Change From Baseline Blink Rate | -2.15 Blinks/min | Standard Deviation 10.161 |
Comparison: Between-group comparison, change from baselinep-value: 0.41295% CI: [-3.1016, 7.4477]ANOVA
Comparison: Within-group change from baselinep-value: 0.991895% CI: [-3.7105, 3.749]ANOVA
Comparison: Within-group change from baselinep-value: 0.251695% CI: [-5.8836, 1.5759]ANOVA
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.
Time frame: From baseline to Day 30 (Part 3)
Population: Per-protocol (PP) dataset
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emulsion Eye Drops | Change From Baseline Conjunctival (Nasal) Staining | -0.27 score on a scale | Standard Deviation 0.608 |
| Control Eye Drops | Change From Baseline Conjunctival (Nasal) Staining | -0.12 score on a scale | Standard Deviation 0.666 |
Comparison: Between-group comparison, change from baselinep-value: 0.59Wilcoxon rank sum test
Comparison: Within-group change from baselinep-value: 0.043Wilcoxon rank sum test
Comparison: Within-group change from baselinep-value: 0.442Wilcoxon rank sum test
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.
Time frame: From baseline to Day 30 (Part 3)
Population: Per-protocol (PP) dataset
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emulsion Eye Drops | Change From Baseline Conjunctival (Temporal) Staining | -0.19 score on a scale | Standard Deviation 0.507 |
| Control Eye Drops | Change From Baseline Conjunctival (Temporal) Staining | -0.02 score on a scale | Standard Deviation 0.81 |
Comparison: Between-group comparison, change from baselinep-value: 0.522Wilcoxon rank sum test
Comparison: Within-group change from baselinep-value: 0.119Wilcoxon rank sum test
Comparison: Within-group change from baselinep-value: 0.9Wilcoxon rank sum test
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.
Time frame: From baseline to Day 30 (Part 3)
Population: Per-protocol (PP) dataset
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emulsion Eye Drops | Change From Baseline Corneal Staining | -0.38 score on a scale | Standard Deviation 0.695 |
| Control Eye Drops | Change From Baseline Corneal Staining | -0.22 score on a scale | Standard Deviation 0.522 |
Comparison: Between-group comparison, change from baselinep-value: 0.447Wilcoxon rank sum test
Comparison: Within-group change from baselinep-value: 0.014Wilcoxon rank sum test
Comparison: Within-group change from baselinep-value: 0.07Wilcoxon rank sum test
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.
Time frame: From baseline to Day 30 (Part 3)
Population: Intent-to-treat (ITT) dataset
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emulsion Eye Drops | Change From Baseline Ocular Protection Index (OPI) | 0.56 ratio | Standard Deviation 1.078 |
| Control Eye Drops | Change From Baseline Ocular Protection Index (OPI) | 0.05 ratio | Standard Deviation 0.68 |
Comparison: Between-group comparison, change from baselinep-value: 0.04795% CI: [0.007267, 1.0113]ANOVA
Comparison: Within-group change from baselinep-value: 0.002695% CI: [0.2046, 0.9146]ANOVA
Comparison: Within-group change from baselinep-value: 0.77795% CI: [-0.3047, 0.4053]ANOVA
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.
Time frame: From baseline to Day 30 (Part 3)
Population: Safety dataset
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emulsion Eye Drops | Change From Baseline Conjunctival Redness | -0.46 score on a scale | Standard Deviation 0.647 |
| Control Eye Drops | Change From Baseline Conjunctival Redness | -0.27 score on a scale | Standard Deviation 0.652 |
Comparison: Between-group comparison, change from baselinep-value: 0.357Wilcoxon rank sum test
Comparison: Within-group change from baselinep-value: 0.001Wilcoxon rank sum test
Comparison: Within-group change from baselinep-value: 0.065Wilcoxon rank sum test
Other Pre-specified
Change From Baseline Intraocular Pressure
Intraocular pressure measured using Goldmann applanation tonometry (mmHg)
Time frame: From baseline to Day 30 (Part 3)
Population: Safety dataset
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emulsion Eye Drops | Change From Baseline Intraocular Pressure | -0.12 mmHg | Standard Deviation 1.705 |
| Control Eye Drops | Change From Baseline Intraocular Pressure | -0.42 mmHg | Standard Deviation 1.653 |
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.
Time frame: From baseline to Day 30 (Part 3)
Population: Safety dataset
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emulsion Eye Drops | Change From Baseline Lid Redness | -0.37 score on a scale | Standard Deviation 0.672 |
| Control Eye Drops | Change From Baseline Lid Redness | -0.19 score on a scale | Standard Deviation 0.549 |
Comparison: Between-group comparison, change from baselinep-value: 0.296Wilcoxon rank sum test
Comparison: Within-group change from baselinep-value: 0.012Wilcoxon rank sum test
Comparison: Within-group change from baselinep-value: >0.05Wilcoxon rank sum test
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)
Time frame: From baseline to Day 30 (Part 3)
Population: ITT population with hyperosmolar tears (mean of eyes ≥308 mOsm/L)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emulsion Eye Drops | Change From Baseline Tear Osmolarity in Hyperosmolar Participants | -17.06 mOsm/L | Standard Deviation 10.425 |
| Control Eye Drops | Change From Baseline Tear Osmolarity in Hyperosmolar Participants | -15.07 mOsm/L | Standard Deviation 16.596 |
Comparison: Between-group comparison, change from baselinep-value: 0.76495% CI: [-15.6117, 11.6295]ANOVA
Comparison: Within-group change from baselinep-value: 0.003895% CI: [-27.928, -6.197]ANOVA
Comparison: Within-group change from baselinep-value: 0.001195% CI: [-23.285, -6.8579]ANOVA
Other Pre-specified
Change From Baseline Visual Acuity
Best corrected visual acuity (ETDRS charts 1 & 2, 2000 series)
Time frame: From baseline to Day 30 (Part 3)
Population: Safety dataset
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emulsion Eye Drops | Change From Baseline Visual Acuity | -0.03 logMAR chart log units | Standard Deviation 0.071 |
| Control Eye Drops | Change From Baseline Visual Acuity | -0.04 logMAR chart log units | Standard Deviation 0.08 |