Trial Outcomes & Findings for A Study to Compare a New Eye Drop Formulation With Systane® Gel Drops and Genteal® Lubricant Gel Drops for Moderate to Severe Dry Eye Relief (NCT NCT02455050)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

79 participants

Primary outcome timeframe

After 14 days of treatment in Period 1 (Follow-up 1 Day 14)

Results posted on

2017-01-04

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.
Treatment Period 1 STARTED	20	19	20	20
Treatment Period 1 COMPLETED	19	18	19	18
Treatment Period 1 NOT COMPLETED	1	1	1	2
Treatment Period 2 STARTED	19	18	19	18
Treatment Period 2 COMPLETED	18	18	17	17
Treatment Period 2 NOT COMPLETED	1	0	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.
Treatment Period 1 Lost to Follow-up	1	1	1	2
Treatment Period 2 Lost to Follow-up	1	0	2	1

Baseline Characteristics

A Study to Compare a New Eye Drop Formulation With Systane® Gel Drops and Genteal® Lubricant Gel Drops for Moderate to Severe Dry Eye Relief

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	New Eye Drop Formulation Then Systane® n=20 Participants 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.	Systane® Then New Eye Drop Formulation n=19 Participants 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.	New Eye Drop Formulation Then Genteal® n=20 Participants 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.	Genteal® Then New Eye Drop Formulation n=20 Participants 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.	Total n=79 Participants Total of all reporting groups
Age, Continuous	44.20 years STANDARD_DEVIATION 13.41 • n=5 Participants	41.79 years STANDARD_DEVIATION 15.86 • n=7 Participants	40.70 years STANDARD_DEVIATION 11.65 • n=5 Participants	45.05 years STANDARD_DEVIATION 17.05 • n=4 Participants	42.95 years STANDARD_DEVIATION 14.45 • n=21 Participants
Gender Female	14 Participants n=5 Participants	15 Participants n=7 Participants	13 Participants n=5 Participants	16 Participants n=4 Participants	58 Participants n=21 Participants
Gender Male	6 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	21 Participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation (Systane® Group) n=20 Participants 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.	Systane® n=19 Participants 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.	New Eye Drop Formulation (Genteal® Group) n=20 Participants 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.	Genteal® n=20 Participants 1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
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	280.17 score on a scale Standard Deviation 90.60	284.89 score on a scale Standard Deviation 86.18	255.83 score on a scale Standard Deviation 94.55
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	134.89 score on a scale Standard Deviation 97.80	101.53 score on a scale Standard Deviation 102.00	109.22 score on a scale Standard Deviation 86.33

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation (Systane® Group) n=19 Participants 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.	Systane® n=18 Participants 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.	New Eye Drop Formulation (Genteal® Group) n=19 Participants 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.	Genteal® n=18 Participants 1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
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	295.00 score on a scale Standard Deviation 60.52	298.82 score on a scale Standard Deviation 109.15	272.12 score on a scale Standard Deviation 125.20
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	120.00 score on a scale Standard Deviation 71.23	54.65 score on a scale Standard Deviation 58.46	98.53 score on a scale Standard Deviation 85.60

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation (Systane® Group) n=20 Participants 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.	Systane® n=19 Participants 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.	New Eye Drop Formulation (Genteal® Group) n=20 Participants 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.	Genteal® n=20 Participants 1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
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	36.98 score on a scale Standard Deviation 13.72	37.39 score on a scale Standard Deviation 15.99	34.79 score on a scale Standard Deviation 10.26
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	25.89 score on a scale Standard Deviation 21.07	22.85 score on a scale Standard Deviation 25.55	23.56 score on a scale Standard Deviation 22.51

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation (Systane® Group) n=18 Participants 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.	Systane® n=19 Participants 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.	New Eye Drop Formulation (Genteal® Group) n=18 Participants 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.	Genteal® n=19 Participants 1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
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	21.77 score on a scale Standard Deviation 23.94	19.65 score on a scale Standard Deviation 15.60	20.42 score on a scale Standard Deviation 22.48
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	20.36 score on a scale Standard Deviation 24.56	18.06 score on a scale Standard Deviation 16.77	23.08 score on a scale Standard Deviation 22.15

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation (Systane® Group) n=20 Participants 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.	Systane® n=19 Participants 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.	New Eye Drop Formulation (Genteal® Group) n=20 Participants 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.	Genteal® n=20 Participants 1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
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	74 percentage of participants	75 percentage of participants	75 percentage of participants
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	74 percentage of participants	70 percentage of participants	70 percentage of participants
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	27 percentage of participants	40 percentage of participants	30 percentage of participants
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	73 percentage of participants	85 percentage of participants	80 percentage of participants
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	79 percentage of participants	70 percentage of participants	75 percentage of participants
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	47.3 percentage of participants	65 percentage of participants	60 percentage of participants
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	58 percentage of participants	65 percentage of participants	65 percentage of participants
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	32 percentage of participants	60 percentage of participants	60 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation (Systane® Group) n=18 Participants 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.	Systane® n=19 Participants 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.	New Eye Drop Formulation (Genteal® Group) n=18 Participants 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.	Genteal® n=19 Participants 1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
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	60 percentage of participants	70 percentage of participants	70 percentage of participants
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	60 percentage of participants	70 percentage of participants	70 percentage of participants
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	15 percentage of participants	20 percentage of participants	30 percentage of participants
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	70 percentage of participants	60 percentage of participants	75 percentage of participants
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	75 percentage of participants	65 percentage of participants	60 percentage of participants
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	45 percentage of participants	55 percentage of participants	70 percentage of participants
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	50 percentage of participants	65 percentage of participants	80 percentage of participants
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	40 percentage of participants	60 percentage of participants	75 percentage of participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation (Systane® Group) n=20 Participants 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.	Systane® n=19 Participants 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.	New Eye Drop Formulation (Genteal® Group) n=20 Participants 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.	Genteal® n=20 Participants 1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
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	2.21 score on a scale Standard Deviation 0.85	2.10 score on a scale Standard Deviation 0.64	2.40 score on a scale Standard Deviation 0.82
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 1.10	1.94 score on a scale Standard Deviation 1.06	2.00 score on a scale Standard Deviation 0.82	2.28 score on a scale Standard Deviation 0.96

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation (Systane® Group) n=18 Participants 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.	Systane® n=19 Participants 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.	New Eye Drop Formulation (Genteal® Group) n=18 Participants 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.	Genteal® n=19 Participants 1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
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	1.50 score on a scale Standard Deviation 1.15	1.67 score on a scale Standard Deviation 0.91	1.84 score on a scale Standard Deviation 0.90
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	2.11 score on a scale Standard Deviation 0.68	2.24 score on a scale Standard Deviation 0.90	1.59 score on a scale Standard Deviation 1.33

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation (Systane® Group) n=39 Participants 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.	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.	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.	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.
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation (Systane® Group) n=40 Participants 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.	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.	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.	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.
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation (Systane® Group) n=20 Participants 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.	Systane® n=19 Participants 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.	New Eye Drop Formulation (Genteal® Group) n=20 Participants 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.	Genteal® n=20 Participants 1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
Distance Visual Acuity in Period 1 Right Eye (OD)_Follow-Up 1 Day 14_5 Min	46.05 Letters Read Correctly Standard Deviation 9.00	46.28 Letters Read Correctly Standard Deviation 6.13	49.00 Letters Read Correctly Standard Deviation 5.98	47.44 Letters Read Correctly Standard Deviation 6.22
Distance Visual Acuity in Period 1 OD_Follow-Up 1 Day 14_30 Min	47.32 Letters Read Correctly Standard Deviation 8.84	50.78 Letters Read Correctly Standard Deviation 4.58	51.05 Letters Read Correctly Standard Deviation 4.49	48.94 Letters Read Correctly Standard Deviation 6.40
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	47.39 Letters Read Correctly Standard Deviation 4.09	49.79 Letters Read Correctly Standard Deviation 5.63	47.78 Letters Read Correctly Standard Deviation 5.06
Distance Visual Acuity in Period 1 OS_Follow-Up 1 Day 14_30 Min	47.53 Letters Read Correctly Standard Deviation 8.59	48.44 Letters Read Correctly Standard Deviation 4.48	50.21 Letters Read Correctly Standard Deviation 5.68	50.94 Letters Read Correctly Standard Deviation 4.05

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation (Systane® Group) n=18 Participants 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.	Systane® n=19 Participants 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.	New Eye Drop Formulation (Genteal® Group) n=18 Participants 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.	Genteal® n=19 Participants 1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
Distance Visual Acuity in Period 2 OD_Follow-Up 2 Day 35_5 Min	48.56 Letters Read Correctly Standard Deviation 5.07	46.56 Letters Read Correctly Standard Deviation 6.51	47.35 Letters Read Correctly Standard Deviation 5.70	48.65 Letters Read Correctly Standard Deviation 5.44
Distance Visual Acuity in Period 2 OD_Follow-Up 2 Day 35_30 Min	51.00 Letters Read Correctly Standard Deviation 5.81	51.11 Letters Read Correctly Standard Deviation 5.47	50.35 Letters Read Correctly Standard Deviation 5.58	51.94 Letters Read Correctly Standard Deviation 3.49
Distance Visual Acuity in Period 2 OS_Follow-Up 2 Day 35_5 Min	48.11 Letters Read Correctly Standard Deviation 6.11	47.11 Letters Read Correctly Standard Deviation 6.28	46.47 Letters Read Correctly Standard Deviation 7.22	49.71 Letters Read Correctly Standard Deviation 4.87
Distance Visual Acuity in Period 2 OS_Follow-Up 2 Day 35_30 Min	51.11 Letters Read Correctly Standard Deviation 5.44	49.11 Letters Read Correctly Standard Deviation 5.68	49.35 Letters Read Correctly Standard Deviation 6.01	51.24 Letters Read Correctly Standard Deviation 3.58

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation (Systane® Group) n=20 Participants 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.	Systane® n=19 Participants 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.	New Eye Drop Formulation (Genteal® Group) n=20 Participants 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.	Genteal® n=20 Participants 1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
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	5.45 seconds Standard Deviation 2.03	4.99 seconds Standard Deviation 1.86	4.27 seconds Standard Deviation 1.03
Tear Break-Up Time With Fluorescein in Period 1 OD_Follow-Up 1 Day 14_30 Min	6.21 seconds Standard Deviation 2.26	5.24 seconds Standard Deviation 1.56	4.86 seconds Standard Deviation 1.81	5.00 seconds Standard Deviation 1.70
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	5.39 seconds Standard Deviation 1.76	5.29 seconds Standard Deviation 1.91	4.36 seconds Standard Deviation 1.30
Tear Break-Up Time With Fluorescein in Period 1 OS_Follow-Up 1 Day 14_30 Min	6.25 seconds Standard Deviation 2.59	5.44 seconds Standard Deviation 1.94	4.89 seconds Standard Deviation 1.61	4.56 seconds Standard Deviation 1.45

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation (Systane® Group) n=18 Participants 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.	Systane® n=19 Participants 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.	New Eye Drop Formulation (Genteal® Group) n=18 Participants 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.	Genteal® n=19 Participants 1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
Tear Break-Up Time With Fluorescein in Period 2 OD_Follow-Up 2 Day 35_ 5 Min	6.31 seconds Standard Deviation 2.58	6.13 seconds Standard Deviation 2.38	4.93 seconds Standard Deviation 1.97	5.63 seconds Standard Deviation 3.49
Tear Break-Up Time With Fluorescein in Period 2 OD_Follow-Up 2 Day 35_30 Min	5.68 seconds Standard Deviation 1.30	6.34 seconds Standard Deviation 3.00	4.94 seconds Standard Deviation 1.28	5.22 seconds Standard Deviation 2.18
Tear Break-Up Time With Fluorescein in Period 2 OS_Follow-Up 2 Day 35_5 Min	5.64 seconds Standard Deviation 2.01	6.35 seconds Standard Deviation 2.54	4.88 seconds Standard Deviation 1.44	4.74 seconds Standard Deviation 2.04
Tear Break-Up Time With Fluorescein in Period 2 OS_Follow-Up 2 Day 35_30 Min	6.06 seconds Standard Deviation 1.57	6.01 seconds Standard Deviation 1.40	5.18 seconds Standard Deviation 1.69	4.65 seconds Standard Deviation 1.27

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation (Systane® Group) n=20 Participants 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.	Systane® n=19 Participants 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.	New Eye Drop Formulation (Genteal® Group) n=20 Participants 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.	Genteal® n=20 Participants 1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
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	3.39 score on a scale Standard Deviation 1.24	3.58 score on a scale Standard Deviation 1.17	3.17 score on a scale Standard Deviation 0.92
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	3.78 score on a scale Standard Deviation 0.94	3.68 score on a scale Standard Deviation 1.00	3.72 score on a scale Standard Deviation 0.67
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 1.10	3.61 score on a scale Standard Deviation 0.98	3.89 score on a scale Standard Deviation 0.88	3.83 score on a scale Standard Deviation 0.86
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	20.44 score on a scale Standard Deviation 39.04	21.11 score on a scale Standard Deviation 27.23	28.61 score on a scale Standard Deviation 23.20
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	4.22 score on a scale Standard Deviation 0.65	3.79 score on a scale Standard Deviation 0.98	4.28 score on a scale Standard Deviation 0.83
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 1.10	4.22 score on a scale Standard Deviation 0.81	4.00 score on a scale Standard Deviation 0.88	4.17 score on a scale Standard Deviation 0.38
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	3.39 score on a scale Standard Deviation 1.24	2.84 score on a scale Standard Deviation 1.12	3.72 score on a scale Standard Deviation 1.07
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	43.17 score on a scale Standard Deviation 26.18	28.42 score on a scale Standard Deviation 26.05	48.06 score on a scale Standard Deviation 21.70

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation (Systane® Group) n=18 Participants 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.	Systane® n=19 Participants 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.	New Eye Drop Formulation (Genteal® Group) n=18 Participants 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.	Genteal® n=19 Participants 1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
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	18.00 score on a scale Standard Deviation 40.11	38.47 score on a scale Standard Deviation 19.01	40.06 score on a scale Standard Deviation 30.92
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	3.28 score on a scale Standard Deviation 0.89	3.94 score on a scale Standard Deviation 0.43	3.82 score on a scale Standard Deviation 0.81
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	3.50 score on a scale Standard Deviation 0.92	3.88 score on a scale Standard Deviation 0.49	4.00 score on a scale Standard Deviation 0.61
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	3.94 score on a scale Standard Deviation 1.06	4.24 score on a scale Standard Deviation 0.56	3.88 score on a scale Standard Deviation 1.05
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	3.94 score on a scale Standard Deviation 0.94	4.24 score on a scale Standard Deviation 0.44	4.00 score on a scale Standard Deviation 1.06
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 0.90	3.89 score on a scale Standard Deviation 1.08	4.29 score on a scale Standard Deviation 0.59	4.06 score on a scale Standard Deviation 1.09
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	26.00 score on a scale Standard Deviation 36.84	47.41 score on a scale Standard Deviation 22.89	52.94 score on a scale Standard Deviation 38.02
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	3.22 score on a scale Standard Deviation 1.06	3.82 score on a scale Standard Deviation 0.81	3.76 score on a scale Standard Deviation 0.83

Adverse Events

New Eye Drop Formulation Then Systane®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Systane® Then New Eye Drop Formulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

New Eye Drop Formulation Then Genteal®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Genteal® Then New Eye Drop Formulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER