| 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). | 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. | Posted | | Mean | Standard Deviation | score on a scale | | After 14 days of treatment in Period 1 (Follow-up 1 Day 14) | | | | ID | Title | Description |
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| OG000 | New Eye Drop Formulation (Systane® Group) | 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. | | OG001 | Systane® | 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1. | | OG002 | New Eye Drop Formulation (Genteal® Group) | 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. | | OG003 | Genteal® | 1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1. |
| | Units | Counts |
|---|
| Participants | - OG00020
- OG00119
- OG00220
- OG003
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| | Title | Denominators | Categories |
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| Positive Questions | | | Title | Measurements |
|---|
| - OG000255.74± 119.69
- OG001280.17± 90.60
- OG002284.89± 86.18
- OG003
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| 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). | 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. | Posted | | Mean | Standard Deviation | score on a scale | | After 14 days of treatment in Period 2 (Follow-up 2 Day 35) | | | | ID | Title | Description |
|---|
| OG000 | Systane® | 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2. | | OG001 | New Eye Drop Formulation (Systane® Group) | 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. |
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| 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. | Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and after 14 days of treatment in Period 1 (Follow-up 1 Day 14) | | | | ID | Title | Description |
|---|
| OG000 | New Eye Drop Formulation (Systane® Group) | 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. | | OG001 | Systane® | 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2. | | OG002 |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and after 14 days of treatment in Period 2 (Follow-up 2 Day 35) | | | | ID | Title | Description |
|---|
| OG000 | New Eye Drop Formulation (Systane® Group) | 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. | | OG001 | Systane® | 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2. | | OG002 |
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| 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. | Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. | Posted | | Number | | percentage of participants | | After 14 days of treatment in Period 1 (Follow-up 1 Day 14) | | | | ID | Title | Description |
|---|
| OG000 | New Eye Drop Formulation (Systane® Group) | 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. | | OG001 | Systane® | 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2. | | OG002 |
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| 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. | 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. | Posted | | Number | | percentage of participants | | After 14 days of treatment in Period 2 (Follow-up 2 Day 35) | | | | ID | Title | Description |
|---|
| OG000 | New Eye Drop Formulation (Systane® Group) | 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. | | OG001 | Systane® | 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2. | | OG002 |
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| 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). | Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and After 14 days of treatment in Period 1 (Follow-up 1 Day 14) | | | | ID | Title | Description |
|---|
| OG000 | New Eye Drop Formulation (Systane® Group) | 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. | | OG001 | Systane® | 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2. | | OG002 | New Eye Drop Formulation (Genteal® Group) | 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 or 2. |
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| 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). | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and After 14 days of treatment in Period 2 (Follow-up 2 Day 35) | | | | ID | Title | Description |
|---|
| OG000 | New Eye Drop Formulation (Systane® Group) | 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. | | OG001 | Systane® | 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2. | | OG002 | New Eye Drop Formulation (Genteal® Group) | 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 or 2. |
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| 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. | 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. | Posted | | Number | | percentage of participants | | Day 35 | | | | ID | Title | Description |
|---|
| OG000 | New Eye Drop Formulation and 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 or 2 and 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2. |
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| 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. | 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. | Posted | | Number | | percentage of participants | | Day 35 | | | | ID | Title | Description |
|---|
| OG000 | New Eye Drop Formulation and 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 or 2 and 1 to 2 drops of Genteal® in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2. |
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| 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). | Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. | Posted | | Mean | Standard Deviation | Letters Read Correctly | | After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation | | | | ID | Title | Description |
|---|
| OG000 | New Eye Drop Formulation (Systane® Group) | 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. | | OG001 | Systane® | 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2. | | OG002 | New Eye Drop Formulation (Genteal® Group) | 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 or 2. | |
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| 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). | 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. | Posted | | Mean | Standard Deviation | Letters Read Correctly | | After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation | | | | ID | Title | Description |
|---|
| OG000 | New Eye Drop Formulation (Systane® Group) | 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. | | OG001 | Systane® | 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2. | | OG002 | New Eye Drop Formulation (Genteal® Group) | 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 or 2. |
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| 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. | Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. | Posted | | Mean | Standard Deviation | seconds | | After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation | | | | ID | Title | Description |
|---|
| OG000 | New Eye Drop Formulation (Systane® Group) | 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. | | OG001 | Systane® | 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2. | | OG002 | New Eye Drop Formulation (Genteal® Group) | 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 or 2. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | seconds | | After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation | | | | ID | Title | Description |
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| OG000 | New Eye Drop Formulation (Systane® Group) | 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. | | OG001 | Systane® | 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2. | | OG002 | New Eye Drop Formulation (Genteal® Group) | 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 or 2. |
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| 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. | Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. | Posted | | Mean | Standard Deviation | score on a scale | | After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation | | | | ID | Title | Description |
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| OG000 | New Eye Drop Formulation (Systane® Group) | 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. | | OG001 | Systane® | 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2. | | OG002 |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation | | | | ID | Title | Description |
|---|
| OG000 | New Eye Drop Formulation (Systane® Group) | 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. | | OG001 | Systane® | 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2. | |
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