Dry Eye Syndromes
Conditions
Brief summary
A study to evaluate the tolerability and acceptability of an investigational eye drop formulation in patients with Dry Eye Disease.
Interventions
1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops \[New Eye Drop Formula\] in each eye.
DRUGSystane® Gel Drops
1 to 2 drops of Systane® Gel Drops in each eye.
DRUGGenteal® Lubricant Gel Drops
1 to 2 drops of Genteal® Lubricant Gel Drops in each eye.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current use of an artificial tear product * Visual Acuity of at least 20/40 (while wearing glasses, if necessary).
Exclusion criteria
* Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study * Cataract surgery, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy within 6 months * Use of RESTASIS® Cyclosporine Ophthalmic Emulsion or any topical cyclosporine within 3 months * Diagnosis of glaucoma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1 | After 14 days of treatment in Period 1 (Follow-up 1 Day 14) | Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst). |
| Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2 | After 14 days of treatment in Period 2 (Follow-up 2 Day 35) | Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | After 14 days of treatment in Period 1 (Follow-up 1 Day 14) | Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported. |
| Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | After 14 days of treatment in Period 2 (Follow-up 2 Day 35) | Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported. |
| Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1 | Baseline and After 14 days of treatment in Period 1 (Follow-up 1 Day 14) | SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities). |
| Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2 | Baseline and After 14 days of treatment in Period 2 (Follow-up 2 Day 35) | SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities). |
| Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®) | Day 35 | End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported. |
| Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®) | Day 35 | End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported. |
| Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1 | Baseline and after 14 days of treatment in Period 1 (Follow-up 1 Day 14) | The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst. |
| Distance Visual Acuity in Period 2 | After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation | Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters). |
| Tear Break-Up Time With Fluorescein in Period 1 | After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation | Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. |
| Tear Break-Up Time With Fluorescein in Period 2 | After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation | Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. |
| Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation | Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable. |
| Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation | Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable. |
| Distance Visual Acuity in Period 1 | After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation | Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters). |
| Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2 | Baseline and after 14 days of treatment in Period 2 (Follow-up 2 Day 35) | The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| New Eye Drop Formulation Then Systane® 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 2. | 20 |
| Systane® Then New Eye Drop Formulation 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2. | 19 |
| New Eye Drop Formulation Then Genteal® 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2. | 20 |
| Genteal® Then New Eye Drop Formulation 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2. | 20 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Treatment Period 1 | Lost to Follow-up | 1 | 1 | 1 | 2 |
| Treatment Period 2 | Lost to Follow-up | 1 | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | New Eye Drop Formulation Then Systane® | Systane® Then New Eye Drop Formulation | New Eye Drop Formulation Then Genteal® | Genteal® Then New Eye Drop Formulation | Total |
|---|---|---|---|---|---|
| Age, Continuous | 44.20 years STANDARD_DEVIATION 13.41 | 41.79 years STANDARD_DEVIATION 15.86 | 40.70 years STANDARD_DEVIATION 11.65 | 45.05 years STANDARD_DEVIATION 17.05 | 42.95 years STANDARD_DEVIATION 14.45 |
| Gender Female | 14 Participants | 15 Participants | 13 Participants | 16 Participants | 58 Participants |
| Gender Male | 6 Participants | 4 Participants | 7 Participants | 4 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 19 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1
Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).
Time frame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14)
Population: Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. Participants enrolled in Period 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Eye Drop Formulation (Systane® Group) | Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1 | Positive Questions | 255.74 score on a scale | Standard Deviation 119.69 |
| New Eye Drop Formulation (Systane® Group) | Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1 | Negative Questions | 86.11 score on a scale | Standard Deviation 87.83 |
| Systane® | Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1 | Negative Questions | 134.89 score on a scale | Standard Deviation 97.8 |
| Systane® | Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1 | Positive Questions | 280.17 score on a scale | Standard Deviation 90.6 |
| New Eye Drop Formulation (Genteal® Group) | Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1 | Negative Questions | 101.53 score on a scale | Standard Deviation 102 |
| New Eye Drop Formulation (Genteal® Group) | Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1 | Positive Questions | 284.89 score on a scale | Standard Deviation 86.18 |
| Genteal® | Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1 | Negative Questions | 109.22 score on a scale | Standard Deviation 86.33 |
| Genteal® | Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1 | Positive Questions | 255.83 score on a scale | Standard Deviation 94.55 |
Primary
Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2
Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).
Time frame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35)
Population: Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Eye Drop Formulation (Systane® Group) | Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2 | Positive Questions | 231.33 score on a scale | Standard Deviation 112.22 |
| New Eye Drop Formulation (Systane® Group) | Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2 | Negative Questions | 102.00 score on a scale | Standard Deviation 76.69 |
| Systane® | Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2 | Negative Questions | 120.00 score on a scale | Standard Deviation 71.23 |
| Systane® | Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2 | Positive Questions | 295.00 score on a scale | Standard Deviation 60.52 |
| New Eye Drop Formulation (Genteal® Group) | Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2 | Positive Questions | 298.82 score on a scale | Standard Deviation 109.15 |
| New Eye Drop Formulation (Genteal® Group) | Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2 | Negative Questions | 54.65 score on a scale | Standard Deviation 58.46 |
| Genteal® | Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2 | Positive Questions | 272.12 score on a scale | Standard Deviation 125.2 |
| Genteal® | Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2 | Negative Questions | 98.53 score on a scale | Standard Deviation 85.6 |
Secondary
Distance Visual Acuity in Period 1
Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters).
Time frame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation
Population: Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Eye Drop Formulation (Systane® Group) | Distance Visual Acuity in Period 1 | Right Eye (OD)_Follow-Up 1 Day 14_5 Min | 46.05 Letters Read Correctly | Standard Deviation 9 |
| New Eye Drop Formulation (Systane® Group) | Distance Visual Acuity in Period 1 | OD_Follow-Up 1 Day 14_30 Min | 47.32 Letters Read Correctly | Standard Deviation 8.84 |
| New Eye Drop Formulation (Systane® Group) | Distance Visual Acuity in Period 1 | Left Eye (OS)_Follow-Up 1 Day 14_5 Min | 45.84 Letters Read Correctly | Standard Deviation 7.76 |
| New Eye Drop Formulation (Systane® Group) | Distance Visual Acuity in Period 1 | OS_Follow-Up 1 Day 14_30 Min | 47.53 Letters Read Correctly | Standard Deviation 8.59 |
| Systane® | Distance Visual Acuity in Period 1 | OD_Follow-Up 1 Day 14_30 Min | 50.78 Letters Read Correctly | Standard Deviation 4.58 |
| Systane® | Distance Visual Acuity in Period 1 | Left Eye (OS)_Follow-Up 1 Day 14_5 Min | 47.39 Letters Read Correctly | Standard Deviation 4.09 |
| Systane® | Distance Visual Acuity in Period 1 | OS_Follow-Up 1 Day 14_30 Min | 48.44 Letters Read Correctly | Standard Deviation 4.48 |
| Systane® | Distance Visual Acuity in Period 1 | Right Eye (OD)_Follow-Up 1 Day 14_5 Min | 46.28 Letters Read Correctly | Standard Deviation 6.13 |
| New Eye Drop Formulation (Genteal® Group) | Distance Visual Acuity in Period 1 | Left Eye (OS)_Follow-Up 1 Day 14_5 Min | 49.79 Letters Read Correctly | Standard Deviation 5.63 |
| New Eye Drop Formulation (Genteal® Group) | Distance Visual Acuity in Period 1 | OD_Follow-Up 1 Day 14_30 Min | 51.05 Letters Read Correctly | Standard Deviation 4.49 |
| New Eye Drop Formulation (Genteal® Group) | Distance Visual Acuity in Period 1 | OS_Follow-Up 1 Day 14_30 Min | 50.21 Letters Read Correctly | Standard Deviation 5.68 |
| New Eye Drop Formulation (Genteal® Group) | Distance Visual Acuity in Period 1 | Right Eye (OD)_Follow-Up 1 Day 14_5 Min | 49.00 Letters Read Correctly | Standard Deviation 5.98 |
| Genteal® | Distance Visual Acuity in Period 1 | OS_Follow-Up 1 Day 14_30 Min | 50.94 Letters Read Correctly | Standard Deviation 4.05 |
| Genteal® | Distance Visual Acuity in Period 1 | OD_Follow-Up 1 Day 14_30 Min | 48.94 Letters Read Correctly | Standard Deviation 6.4 |
| Genteal® | Distance Visual Acuity in Period 1 | Right Eye (OD)_Follow-Up 1 Day 14_5 Min | 47.44 Letters Read Correctly | Standard Deviation 6.22 |
| Genteal® | Distance Visual Acuity in Period 1 | Left Eye (OS)_Follow-Up 1 Day 14_5 Min | 47.78 Letters Read Correctly | Standard Deviation 5.06 |
Secondary
Distance Visual Acuity in Period 2
Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters).
Time frame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation
Population: Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Eye Drop Formulation (Systane® Group) | Distance Visual Acuity in Period 2 | OD_Follow-Up 2 Day 35_5 Min | 48.56 Letters Read Correctly | Standard Deviation 5.07 |
| New Eye Drop Formulation (Systane® Group) | Distance Visual Acuity in Period 2 | OD_Follow-Up 2 Day 35_30 Min | 51.00 Letters Read Correctly | Standard Deviation 5.81 |
| New Eye Drop Formulation (Systane® Group) | Distance Visual Acuity in Period 2 | OS_Follow-Up 2 Day 35_5 Min | 48.11 Letters Read Correctly | Standard Deviation 6.11 |
| New Eye Drop Formulation (Systane® Group) | Distance Visual Acuity in Period 2 | OS_Follow-Up 2 Day 35_30 Min | 51.11 Letters Read Correctly | Standard Deviation 5.44 |
| Systane® | Distance Visual Acuity in Period 2 | OD_Follow-Up 2 Day 35_30 Min | 51.11 Letters Read Correctly | Standard Deviation 5.47 |
| Systane® | Distance Visual Acuity in Period 2 | OS_Follow-Up 2 Day 35_5 Min | 47.11 Letters Read Correctly | Standard Deviation 6.28 |
| Systane® | Distance Visual Acuity in Period 2 | OS_Follow-Up 2 Day 35_30 Min | 49.11 Letters Read Correctly | Standard Deviation 5.68 |
| Systane® | Distance Visual Acuity in Period 2 | OD_Follow-Up 2 Day 35_5 Min | 46.56 Letters Read Correctly | Standard Deviation 6.51 |
| New Eye Drop Formulation (Genteal® Group) | Distance Visual Acuity in Period 2 | OS_Follow-Up 2 Day 35_5 Min | 46.47 Letters Read Correctly | Standard Deviation 7.22 |
| New Eye Drop Formulation (Genteal® Group) | Distance Visual Acuity in Period 2 | OD_Follow-Up 2 Day 35_30 Min | 50.35 Letters Read Correctly | Standard Deviation 5.58 |
| New Eye Drop Formulation (Genteal® Group) | Distance Visual Acuity in Period 2 | OS_Follow-Up 2 Day 35_30 Min | 49.35 Letters Read Correctly | Standard Deviation 6.01 |
| New Eye Drop Formulation (Genteal® Group) | Distance Visual Acuity in Period 2 | OD_Follow-Up 2 Day 35_5 Min | 47.35 Letters Read Correctly | Standard Deviation 5.7 |
| Genteal® | Distance Visual Acuity in Period 2 | OS_Follow-Up 2 Day 35_30 Min | 51.24 Letters Read Correctly | Standard Deviation 3.58 |
| Genteal® | Distance Visual Acuity in Period 2 | OD_Follow-Up 2 Day 35_30 Min | 51.94 Letters Read Correctly | Standard Deviation 3.49 |
| Genteal® | Distance Visual Acuity in Period 2 | OD_Follow-Up 2 Day 35_5 Min | 48.65 Letters Read Correctly | Standard Deviation 5.44 |
| Genteal® | Distance Visual Acuity in Period 2 | OS_Follow-Up 2 Day 35_5 Min | 49.71 Letters Read Correctly | Standard Deviation 4.87 |
Secondary
Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1
Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable.
Time frame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation
Population: Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Eye Drop Formulation (Systane® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q1 Follow-up 1 Day 14_30 Min | 3.84 score on a scale | Standard Deviation 1.07 |
| New Eye Drop Formulation (Systane® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q4 Follow-up 1 Day 14_30 Min | 30.05 score on a scale | Standard Deviation 34.98 |
| New Eye Drop Formulation (Systane® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q3 Follow-up 1 Day 14_5 Min | 3.74 score on a scale | Standard Deviation 1.1 |
| New Eye Drop Formulation (Systane® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q2 Follow-up 1 Day 14_30 Min | 3.89 score on a scale | Standard Deviation 1.1 |
| New Eye Drop Formulation (Systane® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q1 Follow-up 1 Day 14_5 Minutes (Min) | 3.32 score on a scale | Standard Deviation 1.29 |
| New Eye Drop Formulation (Systane® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q2 Follow-up 1 Day 14_5 Min | 3.53 score on a scale | Standard Deviation 1.35 |
| New Eye Drop Formulation (Systane® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q4 Follow-up 1 Day 14_5 Min | 26.89 score on a scale | Standard Deviation 33.95 |
| New Eye Drop Formulation (Systane® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q3 Follow-up 1 Day 14_30 Min | 3.47 score on a scale | Standard Deviation 1.58 |
| Systane® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q4 Follow-up 1 Day 14_5 Min | 20.44 score on a scale | Standard Deviation 39.04 |
| Systane® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q1 Follow-up 1 Day 14_30 Min | 4.22 score on a scale | Standard Deviation 0.65 |
| Systane® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q4 Follow-up 1 Day 14_30 Min | 43.17 score on a scale | Standard Deviation 26.18 |
| Systane® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q2 Follow-up 1 Day 14_5 Min | 3.78 score on a scale | Standard Deviation 0.94 |
| Systane® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q1 Follow-up 1 Day 14_5 Minutes (Min) | 3.39 score on a scale | Standard Deviation 1.24 |
| Systane® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q3 Follow-up 1 Day 14_5 Min | 3.61 score on a scale | Standard Deviation 0.98 |
| Systane® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q3 Follow-up 1 Day 14_30 Min | 3.39 score on a scale | Standard Deviation 1.24 |
| Systane® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q2 Follow-up 1 Day 14_30 Min | 4.22 score on a scale | Standard Deviation 0.81 |
| New Eye Drop Formulation (Genteal® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q4 Follow-up 1 Day 14_5 Min | 21.11 score on a scale | Standard Deviation 27.23 |
| New Eye Drop Formulation (Genteal® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q4 Follow-up 1 Day 14_30 Min | 28.42 score on a scale | Standard Deviation 26.05 |
| New Eye Drop Formulation (Genteal® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q1 Follow-up 1 Day 14_5 Minutes (Min) | 3.58 score on a scale | Standard Deviation 1.17 |
| New Eye Drop Formulation (Genteal® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q2 Follow-up 1 Day 14_5 Min | 3.68 score on a scale | Standard Deviation 1 |
| New Eye Drop Formulation (Genteal® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q3 Follow-up 1 Day 14_5 Min | 3.89 score on a scale | Standard Deviation 0.88 |
| New Eye Drop Formulation (Genteal® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q1 Follow-up 1 Day 14_30 Min | 3.79 score on a scale | Standard Deviation 0.98 |
| New Eye Drop Formulation (Genteal® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q2 Follow-up 1 Day 14_30 Min | 4.00 score on a scale | Standard Deviation 0.88 |
| New Eye Drop Formulation (Genteal® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q3 Follow-up 1 Day 14_30 Min | 2.84 score on a scale | Standard Deviation 1.12 |
| Genteal® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q2 Follow-up 1 Day 14_30 Min | 4.17 score on a scale | Standard Deviation 0.38 |
| Genteal® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q4 Follow-up 1 Day 14_5 Min | 28.61 score on a scale | Standard Deviation 23.2 |
| Genteal® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q3 Follow-up 1 Day 14_5 Min | 3.83 score on a scale | Standard Deviation 0.86 |
| Genteal® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q4 Follow-up 1 Day 14_30 Min | 48.06 score on a scale | Standard Deviation 21.7 |
| Genteal® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q3 Follow-up 1 Day 14_30 Min | 3.72 score on a scale | Standard Deviation 1.07 |
| Genteal® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q2 Follow-up 1 Day 14_5 Min | 3.72 score on a scale | Standard Deviation 0.67 |
| Genteal® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q1 Follow-up 1 Day 14_30 Min | 4.28 score on a scale | Standard Deviation 0.83 |
| Genteal® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 | Q1 Follow-up 1 Day 14_5 Minutes (Min) | 3.17 score on a scale | Standard Deviation 0.92 |
Secondary
Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2
Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable.
Time frame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation
Population: Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Eye Drop Formulation (Systane® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q4 Follow-up 2 Day 35_30 Min | 33.11 score on a scale | Standard Deviation 26.87 |
| New Eye Drop Formulation (Systane® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q2 Follow-up 2 Day 35_30 Min | 3.83 score on a scale | Standard Deviation 0.62 |
| New Eye Drop Formulation (Systane® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q3 Follow-up 2 Day 35_5 Min | 3.72 score on a scale | Standard Deviation 0.89 |
| New Eye Drop Formulation (Systane® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q2 Follow-up 2 Day 35_5 Min | 3.67 score on a scale | Standard Deviation 0.97 |
| New Eye Drop Formulation (Systane® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q1 Follow-up 2 Day 35 _5 Min | 3.22 score on a scale | Standard Deviation 1.11 |
| New Eye Drop Formulation (Systane® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q3 Follow-up 2 Day 35_30 Min | 3.89 score on a scale | Standard Deviation 0.9 |
| New Eye Drop Formulation (Systane® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q4 Follow-up 2 Day 35_5 Min | 26.89 score on a scale | Standard Deviation 29.66 |
| New Eye Drop Formulation (Systane® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q1 Follow-up 2 Day 35_30 Min | 4.11 score on a scale | Standard Deviation 0.76 |
| Systane® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q4 Follow-up 2 Day 35_5 Min | 18.00 score on a scale | Standard Deviation 40.11 |
| Systane® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q2 Follow-up 2 Day 35_30 Min | 3.94 score on a scale | Standard Deviation 0.94 |
| Systane® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q1 Follow-up 2 Day 35_30 Min | 3.94 score on a scale | Standard Deviation 1.06 |
| Systane® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q2 Follow-up 2 Day 35_5 Min | 3.28 score on a scale | Standard Deviation 0.89 |
| Systane® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q4 Follow-up 2 Day 35_30 Min | 26.00 score on a scale | Standard Deviation 36.84 |
| Systane® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q3 Follow-up 2 Day 35_30 Min | 3.89 score on a scale | Standard Deviation 1.08 |
| Systane® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q3 Follow-up 2 Day 35_5 Min | 3.50 score on a scale | Standard Deviation 0.92 |
| Systane® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q1 Follow-up 2 Day 35 _5 Min | 3.22 score on a scale | Standard Deviation 1.06 |
| New Eye Drop Formulation (Genteal® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q1 Follow-up 2 Day 35 _5 Min | 3.82 score on a scale | Standard Deviation 0.81 |
| New Eye Drop Formulation (Genteal® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q3 Follow-up 2 Day 35_30 Min | 4.29 score on a scale | Standard Deviation 0.59 |
| New Eye Drop Formulation (Genteal® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q2 Follow-up 2 Day 35_5 Min | 3.94 score on a scale | Standard Deviation 0.43 |
| New Eye Drop Formulation (Genteal® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q3 Follow-up 2 Day 35_5 Min | 3.88 score on a scale | Standard Deviation 0.49 |
| New Eye Drop Formulation (Genteal® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q4 Follow-up 2 Day 35_5 Min | 38.47 score on a scale | Standard Deviation 19.01 |
| New Eye Drop Formulation (Genteal® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q1 Follow-up 2 Day 35_30 Min | 4.24 score on a scale | Standard Deviation 0.56 |
| New Eye Drop Formulation (Genteal® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q2 Follow-up 2 Day 35_30 Min | 4.24 score on a scale | Standard Deviation 0.44 |
| New Eye Drop Formulation (Genteal® Group) | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q4 Follow-up 2 Day 35_30 Min | 47.41 score on a scale | Standard Deviation 22.89 |
| Genteal® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q2 Follow-up 2 Day 35_30 Min | 4.00 score on a scale | Standard Deviation 1.06 |
| Genteal® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q3 Follow-up 2 Day 35_5 Min | 4.00 score on a scale | Standard Deviation 0.61 |
| Genteal® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q2 Follow-up 2 Day 35_5 Min | 3.82 score on a scale | Standard Deviation 0.81 |
| Genteal® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q3 Follow-up 2 Day 35_30 Min | 4.06 score on a scale | Standard Deviation 1.09 |
| Genteal® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q1 Follow-up 2 Day 35 _5 Min | 3.76 score on a scale | Standard Deviation 0.83 |
| Genteal® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q1 Follow-up 2 Day 35_30 Min | 3.88 score on a scale | Standard Deviation 1.05 |
| Genteal® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q4 Follow-up 2 Day 35_5 Min | 40.06 score on a scale | Standard Deviation 30.92 |
| Genteal® | Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 | Q4 Follow-up 2 Day 35_30 Min | 52.94 score on a scale | Standard Deviation 38.02 |
Secondary
Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1
The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst.
Time frame: Baseline and after 14 days of treatment in Period 1 (Follow-up 1 Day 14)
Population: Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Eye Drop Formulation (Systane® Group) | Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1 | Follow-up 1_Day 14 | 27.45 score on a scale | Standard Deviation 23.49 |
| New Eye Drop Formulation (Systane® Group) | Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1 | Baseline_Period 1 | 34.76 score on a scale | Standard Deviation 13.88 |
| Systane® | Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1 | Follow-up 1_Day 14 | 25.89 score on a scale | Standard Deviation 21.07 |
| Systane® | Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1 | Baseline_Period 1 | 36.98 score on a scale | Standard Deviation 13.72 |
| New Eye Drop Formulation (Genteal® Group) | Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1 | Baseline_Period 1 | 37.39 score on a scale | Standard Deviation 15.99 |
| New Eye Drop Formulation (Genteal® Group) | Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1 | Follow-up 1_Day 14 | 22.85 score on a scale | Standard Deviation 25.55 |
| Genteal® | Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1 | Follow-up 1_Day 14 | 23.56 score on a scale | Standard Deviation 22.51 |
| Genteal® | Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1 | Baseline_Period 1 | 34.79 score on a scale | Standard Deviation 10.26 |
Secondary
Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2
The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst.
Time frame: Baseline and after 14 days of treatment in Period 2 (Follow-up 2 Day 35)
Population: Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Eye Drop Formulation (Systane® Group) | Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2 | Baseline_Period 2 | 21.98 score on a scale | Standard Deviation 21.85 |
| New Eye Drop Formulation (Systane® Group) | Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2 | Follow-up 2_Day 35 | 25.88 score on a scale | Standard Deviation 24.04 |
| Systane® | Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2 | Follow-up 2_Day 35 | 21.77 score on a scale | Standard Deviation 23.94 |
| Systane® | Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2 | Baseline_Period 2 | 20.36 score on a scale | Standard Deviation 24.56 |
| New Eye Drop Formulation (Genteal® Group) | Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2 | Follow-up 2_Day 35 | 19.65 score on a scale | Standard Deviation 15.6 |
| New Eye Drop Formulation (Genteal® Group) | Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2 | Baseline_Period 2 | 18.06 score on a scale | Standard Deviation 16.77 |
| Genteal® | Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2 | Follow-up 2_Day 35 | 20.42 score on a scale | Standard Deviation 22.48 |
| Genteal® | Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2 | Baseline_Period 2 | 23.08 score on a scale | Standard Deviation 22.15 |
Secondary
Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®)
End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported.
Time frame: Day 35
Population: Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. Data is missing for 6 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®) | Comfort_Prefer New Eye Drop Formulation | 22 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®) | Comfort_Prefer Genteal® | 42 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®) | Comfort_Prefer Neither | 20 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®) | Symptom Relief_Prefer New Eye Drop Formulation | 22 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®) | Symptom Relief_Prefer Genteal® | 45 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®) | Symptom Relief_Prefer Neither | 18 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®) | Less blurring_Prefer New Eye Drop Formulation | 20 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®) | Less blurring_Prefer Genteal® | 45 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®) | Less blurring_Prefer Neither | 20 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®) | Purchase_Prefer New Eye Drop Formulation | 20 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®) | Purchase_Prefer Genteal® | 45 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®) | Purchase_Prefer Neither | 20 percentage of participants |
Secondary
Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®)
End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported.
Time frame: Day 35
Population: Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. Data is missing for 3 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®) | Comfort_Prefer New Eye Drop Formulation | 31 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®) | Comfort_Prefer Systane® | 33 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®) | Comfort_Prefer Neither | 28 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®) | Symptom Relief_Prefer New Eye Drop Formulation | 26 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®) | Symptom Relief_Prefer Systane® | 36 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®) | Symptom Relief_Prefer Neither | 31 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®) | Less blurring_Prefer New Eye Drop Formulation | 41 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®) | Less blurring_Prefer Systane® | 31 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®) | Less blurring_Prefer Neither | 21 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®) | Purchase_Prefer New Eye Drop Formulation | 33 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®) | Purchase_Prefer Systane® | 31 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®) | Purchase_Prefer Neither | 28 percentage of participants |
Secondary
Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1
Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported.
Time frame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14)
Population: Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q5_Follow-up 1 Day 14 | 60 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q1_Follow-up 1 Day 14 | 60 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q6_Follow-up 1 Day 14 | 55 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q3_Follow-up 1 Day 14 | 35 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q7_Follow-up 1 Day 14 | 60 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q4_Follow-up 1 Day 14 | 70 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q2_Follow-up 1 Day 14 | 70 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q8_Follow-up 1 Day 14 | 40 percentage of participants |
| Systane® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q5_Follow-up 1 Day 14 | 79 percentage of participants |
| Systane® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q3_Follow-up 1 Day 14 | 27 percentage of participants |
| Systane® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q2_Follow-up 1 Day 14 | 74 percentage of participants |
| Systane® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q4_Follow-up 1 Day 14 | 73 percentage of participants |
| Systane® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q1_Follow-up 1 Day 14 | 74 percentage of participants |
| Systane® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q8_Follow-up 1 Day 14 | 32 percentage of participants |
| Systane® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q6_Follow-up 1 Day 14 | 47.3 percentage of participants |
| Systane® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q7_Follow-up 1 Day 14 | 58 percentage of participants |
| New Eye Drop Formulation (Genteal® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q8_Follow-up 1 Day 14 | 60 percentage of participants |
| New Eye Drop Formulation (Genteal® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q1_Follow-up 1 Day 14 | 75 percentage of participants |
| New Eye Drop Formulation (Genteal® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q2_Follow-up 1 Day 14 | 70 percentage of participants |
| New Eye Drop Formulation (Genteal® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q5_Follow-up 1 Day 14 | 70 percentage of participants |
| New Eye Drop Formulation (Genteal® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q7_Follow-up 1 Day 14 | 65 percentage of participants |
| New Eye Drop Formulation (Genteal® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q3_Follow-up 1 Day 14 | 40 percentage of participants |
| New Eye Drop Formulation (Genteal® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q4_Follow-up 1 Day 14 | 85 percentage of participants |
| New Eye Drop Formulation (Genteal® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q6_Follow-up 1 Day 14 | 65 percentage of participants |
| Genteal® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q4_Follow-up 1 Day 14 | 80 percentage of participants |
| Genteal® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q2_Follow-up 1 Day 14 | 70 percentage of participants |
| Genteal® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q5_Follow-up 1 Day 14 | 75 percentage of participants |
| Genteal® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q1_Follow-up 1 Day 14 | 75 percentage of participants |
| Genteal® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q6_Follow-up 1 Day 14 | 60 percentage of participants |
| Genteal® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q7_Follow-up 1 Day 14 | 65 percentage of participants |
| Genteal® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q3_Follow-up 1 Day 14 | 30 percentage of participants |
| Genteal® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 | Q8_Follow-up 1 Day 14 | 60 percentage of participants |
Secondary
Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2
Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported.
Time frame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35)
Population: Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q1_Follow-up 2 Day 35 | 64 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q2_Follow-up 2 Day 35 | 79 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q3_Follow-up 2 Day 35 | 11 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q4_Follow-up 2 Day 35 | 69 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q5_Follow-up 2 Day 35 | 52 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q6_Follow-up 2 Day 35 | 58 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q7_Follow-up 1 Day 35 | 63 percentage of participants |
| New Eye Drop Formulation (Systane® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q8_Follow-up 2 Day 35 | 52 percentage of participants |
| Systane® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q6_Follow-up 2 Day 35 | 45 percentage of participants |
| Systane® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q5_Follow-up 2 Day 35 | 75 percentage of participants |
| Systane® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q2_Follow-up 2 Day 35 | 60 percentage of participants |
| Systane® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q8_Follow-up 2 Day 35 | 40 percentage of participants |
| Systane® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q7_Follow-up 1 Day 35 | 50 percentage of participants |
| Systane® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q4_Follow-up 2 Day 35 | 70 percentage of participants |
| Systane® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q3_Follow-up 2 Day 35 | 15 percentage of participants |
| Systane® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q1_Follow-up 2 Day 35 | 60 percentage of participants |
| New Eye Drop Formulation (Genteal® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q7_Follow-up 1 Day 35 | 65 percentage of participants |
| New Eye Drop Formulation (Genteal® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q3_Follow-up 2 Day 35 | 20 percentage of participants |
| New Eye Drop Formulation (Genteal® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q4_Follow-up 2 Day 35 | 60 percentage of participants |
| New Eye Drop Formulation (Genteal® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q5_Follow-up 2 Day 35 | 65 percentage of participants |
| New Eye Drop Formulation (Genteal® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q6_Follow-up 2 Day 35 | 55 percentage of participants |
| New Eye Drop Formulation (Genteal® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q8_Follow-up 2 Day 35 | 60 percentage of participants |
| New Eye Drop Formulation (Genteal® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q1_Follow-up 2 Day 35 | 70 percentage of participants |
| New Eye Drop Formulation (Genteal® Group) | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q2_Follow-up 2 Day 35 | 70 percentage of participants |
| Genteal® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q3_Follow-up 2 Day 35 | 30 percentage of participants |
| Genteal® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q4_Follow-up 2 Day 35 | 75 percentage of participants |
| Genteal® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q2_Follow-up 2 Day 35 | 70 percentage of participants |
| Genteal® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q1_Follow-up 2 Day 35 | 70 percentage of participants |
| Genteal® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q5_Follow-up 2 Day 35 | 60 percentage of participants |
| Genteal® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q8_Follow-up 2 Day 35 | 75 percentage of participants |
| Genteal® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q7_Follow-up 1 Day 35 | 80 percentage of participants |
| Genteal® | Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 | Q6_Follow-up 2 Day 35 | 70 percentage of participants |
Secondary
Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1
SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities).
Time frame: Baseline and After 14 days of treatment in Period 1 (Follow-up 1 Day 14)
Population: Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Eye Drop Formulation (Systane® Group) | Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1 | Baseline_Period 1 | 2.50 score on a scale | Standard Deviation 0.89 |
| New Eye Drop Formulation (Systane® Group) | Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1 | Follow-up 1_Day 14 | 2.26 score on a scale | Standard Deviation 1.1 |
| Systane® | Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1 | Follow-up 1_Day 14 | 1.94 score on a scale | Standard Deviation 1.06 |
| Systane® | Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1 | Baseline_Period 1 | 2.21 score on a scale | Standard Deviation 0.85 |
| New Eye Drop Formulation (Genteal® Group) | Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1 | Baseline_Period 1 | 2.10 score on a scale | Standard Deviation 0.64 |
| New Eye Drop Formulation (Genteal® Group) | Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1 | Follow-up 1_Day 14 | 2.00 score on a scale | Standard Deviation 0.82 |
| Genteal® | Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1 | Baseline_Period 1 | 2.40 score on a scale | Standard Deviation 0.82 |
| Genteal® | Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1 | Follow-up 1_Day 14 | 2.28 score on a scale | Standard Deviation 0.96 |
Secondary
Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2
SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities).
Time frame: Baseline and After 14 days of treatment in Period 2 (Follow-up 2 Day 35)
Population: Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Eye Drop Formulation (Systane® Group) | Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2 | Baseline_Period 2 | 1.56 score on a scale | Standard Deviation 1.15 |
| New Eye Drop Formulation (Systane® Group) | Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2 | Follow-Up 2_Day 35 | 1.50 score on a scale | Standard Deviation 0.92 |
| Systane® | Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2 | Follow-Up 2_Day 35 | 2.11 score on a scale | Standard Deviation 0.68 |
| Systane® | Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2 | Baseline_Period 2 | 1.50 score on a scale | Standard Deviation 1.15 |
| New Eye Drop Formulation (Genteal® Group) | Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2 | Baseline_Period 2 | 1.67 score on a scale | Standard Deviation 0.91 |
| New Eye Drop Formulation (Genteal® Group) | Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2 | Follow-Up 2_Day 35 | 2.24 score on a scale | Standard Deviation 0.9 |
| Genteal® | Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2 | Baseline_Period 2 | 1.84 score on a scale | Standard Deviation 0.9 |
| Genteal® | Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2 | Follow-Up 2_Day 35 | 1.59 score on a scale | Standard Deviation 1.33 |
Secondary
Tear Break-Up Time With Fluorescein in Period 1
Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.
Time frame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation
Population: Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Eye Drop Formulation (Systane® Group) | Tear Break-Up Time With Fluorescein in Period 1 | Right Eye (OD)_Follow-Up 1 Day 14_5 Min | 5.17 seconds | Standard Deviation 1.89 |
| New Eye Drop Formulation (Systane® Group) | Tear Break-Up Time With Fluorescein in Period 1 | OD_Follow-Up 1 Day 14_30 Min | 6.21 seconds | Standard Deviation 2.26 |
| New Eye Drop Formulation (Systane® Group) | Tear Break-Up Time With Fluorescein in Period 1 | Left Eye (OS)_Follow-Up 1 Day 14_5 Min | 5.20 seconds | Standard Deviation 1.93 |
| New Eye Drop Formulation (Systane® Group) | Tear Break-Up Time With Fluorescein in Period 1 | OS_Follow-Up 1 Day 14_30 Min | 6.25 seconds | Standard Deviation 2.59 |
| Systane® | Tear Break-Up Time With Fluorescein in Period 1 | OD_Follow-Up 1 Day 14_30 Min | 5.24 seconds | Standard Deviation 1.56 |
| Systane® | Tear Break-Up Time With Fluorescein in Period 1 | Left Eye (OS)_Follow-Up 1 Day 14_5 Min | 5.39 seconds | Standard Deviation 1.76 |
| Systane® | Tear Break-Up Time With Fluorescein in Period 1 | OS_Follow-Up 1 Day 14_30 Min | 5.44 seconds | Standard Deviation 1.94 |
| Systane® | Tear Break-Up Time With Fluorescein in Period 1 | Right Eye (OD)_Follow-Up 1 Day 14_5 Min | 5.45 seconds | Standard Deviation 2.03 |
| New Eye Drop Formulation (Genteal® Group) | Tear Break-Up Time With Fluorescein in Period 1 | Left Eye (OS)_Follow-Up 1 Day 14_5 Min | 5.29 seconds | Standard Deviation 1.91 |
| New Eye Drop Formulation (Genteal® Group) | Tear Break-Up Time With Fluorescein in Period 1 | OD_Follow-Up 1 Day 14_30 Min | 4.86 seconds | Standard Deviation 1.81 |
| New Eye Drop Formulation (Genteal® Group) | Tear Break-Up Time With Fluorescein in Period 1 | OS_Follow-Up 1 Day 14_30 Min | 4.89 seconds | Standard Deviation 1.61 |
| New Eye Drop Formulation (Genteal® Group) | Tear Break-Up Time With Fluorescein in Period 1 | Right Eye (OD)_Follow-Up 1 Day 14_5 Min | 4.99 seconds | Standard Deviation 1.86 |
| Genteal® | Tear Break-Up Time With Fluorescein in Period 1 | OS_Follow-Up 1 Day 14_30 Min | 4.56 seconds | Standard Deviation 1.45 |
| Genteal® | Tear Break-Up Time With Fluorescein in Period 1 | OD_Follow-Up 1 Day 14_30 Min | 5.00 seconds | Standard Deviation 1.7 |
| Genteal® | Tear Break-Up Time With Fluorescein in Period 1 | Right Eye (OD)_Follow-Up 1 Day 14_5 Min | 4.27 seconds | Standard Deviation 1.03 |
| Genteal® | Tear Break-Up Time With Fluorescein in Period 1 | Left Eye (OS)_Follow-Up 1 Day 14_5 Min | 4.36 seconds | Standard Deviation 1.3 |
Secondary
Tear Break-Up Time With Fluorescein in Period 2
Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.
Time frame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation
Population: Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Eye Drop Formulation (Systane® Group) | Tear Break-Up Time With Fluorescein in Period 2 | OD_Follow-Up 2 Day 35_ 5 Min | 6.31 seconds | Standard Deviation 2.58 |
| New Eye Drop Formulation (Systane® Group) | Tear Break-Up Time With Fluorescein in Period 2 | OD_Follow-Up 2 Day 35_30 Min | 5.68 seconds | Standard Deviation 1.3 |
| New Eye Drop Formulation (Systane® Group) | Tear Break-Up Time With Fluorescein in Period 2 | OS_Follow-Up 2 Day 35_5 Min | 5.64 seconds | Standard Deviation 2.01 |
| New Eye Drop Formulation (Systane® Group) | Tear Break-Up Time With Fluorescein in Period 2 | OS_Follow-Up 2 Day 35_30 Min | 6.06 seconds | Standard Deviation 1.57 |
| Systane® | Tear Break-Up Time With Fluorescein in Period 2 | OD_Follow-Up 2 Day 35_30 Min | 6.34 seconds | Standard Deviation 3 |
| Systane® | Tear Break-Up Time With Fluorescein in Period 2 | OS_Follow-Up 2 Day 35_5 Min | 6.35 seconds | Standard Deviation 2.54 |
| Systane® | Tear Break-Up Time With Fluorescein in Period 2 | OS_Follow-Up 2 Day 35_30 Min | 6.01 seconds | Standard Deviation 1.4 |
| Systane® | Tear Break-Up Time With Fluorescein in Period 2 | OD_Follow-Up 2 Day 35_ 5 Min | 6.13 seconds | Standard Deviation 2.38 |
| New Eye Drop Formulation (Genteal® Group) | Tear Break-Up Time With Fluorescein in Period 2 | OS_Follow-Up 2 Day 35_5 Min | 4.88 seconds | Standard Deviation 1.44 |
| New Eye Drop Formulation (Genteal® Group) | Tear Break-Up Time With Fluorescein in Period 2 | OD_Follow-Up 2 Day 35_30 Min | 4.94 seconds | Standard Deviation 1.28 |
| New Eye Drop Formulation (Genteal® Group) | Tear Break-Up Time With Fluorescein in Period 2 | OS_Follow-Up 2 Day 35_30 Min | 5.18 seconds | Standard Deviation 1.69 |
| New Eye Drop Formulation (Genteal® Group) | Tear Break-Up Time With Fluorescein in Period 2 | OD_Follow-Up 2 Day 35_ 5 Min | 4.93 seconds | Standard Deviation 1.97 |
| Genteal® | Tear Break-Up Time With Fluorescein in Period 2 | OS_Follow-Up 2 Day 35_30 Min | 4.65 seconds | Standard Deviation 1.27 |
| Genteal® | Tear Break-Up Time With Fluorescein in Period 2 | OD_Follow-Up 2 Day 35_30 Min | 5.22 seconds | Standard Deviation 2.18 |
| Genteal® | Tear Break-Up Time With Fluorescein in Period 2 | OD_Follow-Up 2 Day 35_ 5 Min | 5.63 seconds | Standard Deviation 3.49 |
| Genteal® | Tear Break-Up Time With Fluorescein in Period 2 | OS_Follow-Up 2 Day 35_5 Min | 4.74 seconds | Standard Deviation 2.04 |