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

Study Overview
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Brief Summary
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A study to evaluate the tolerability and acceptability of an investigational eye drop formulation in patients with Dry Eye Disease.

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Carboxymethylcellulose Sodium Based Eye Drops
* Drug: Systane® Gel Drops
* Drug: Genteal® Lubricant Gel Drops


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: New Eye Drop Formulation then Systane®<br>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 followed by 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks. | Drug: Carboxymethylcellulose Sodium Based Eye Drops<br>* 1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops [New Eye Drop Formula] in each eye.<br>Drug: Systane® Gel Drops<br>* 1 to 2 drops of Systane® Gel Drops in each eye.<br>* Other names: 1 to 2 drops of Systane® Gel Drops in each eye daily.;|
| Other: Systane® then New Eye Drop Formulation<br>1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks 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. | Drug: Carboxymethylcellulose Sodium Based Eye Drops<br>* 1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops [New Eye Drop Formula] in each eye.<br>Drug: Systane® Gel Drops<br>* 1 to 2 drops of Systane® Gel Drops in each eye.<br>* Other names: 1 to 2 drops of Systane® Gel Drops in each eye daily.;|
| Other: Genteal® then New Eye Drop Formulation<br>1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks 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. | Drug: Carboxymethylcellulose Sodium Based Eye Drops<br>* 1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops [New Eye Drop Formula] in each eye.<br>Drug: Genteal® Lubricant Gel Drops<br>* 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye.<br>|
| Other: New Eye Drop Formulation then Genteal®<br>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 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks. | Drug: Carboxymethylcellulose Sodium Based Eye Drops<br>* 1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops [New Eye Drop Formula] in each eye.<br>Drug: Genteal® Lubricant Gel Drops<br>* 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | After 14 days of treatment in Period 1 (Follow-up 1 Day 14) | 
| 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). | After 14 days of treatment in Period 2 (Follow-up 2 Day 35) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and after 14 days of treatment in Period 1 (Follow-up 1 Day 14) | 
| 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. | Baseline and after 14 days of treatment in Period 2 (Follow-up 2 Day 35) | 
| 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. | After 14 days of treatment in Period 1 (Follow-up 1 Day 14) | 
| 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. | After 14 days of treatment in Period 2 (Follow-up 2 Day 35) | 
| 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). | Baseline and After 14 days of treatment in Period 1 (Follow-up 1 Day 14) | 
| 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). | Baseline and After 14 days of treatment in Period 2 (Follow-up 2 Day 35) | 
| 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. | Day 35 | 
| 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. | Day 35 | 
| 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). | After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation | 
| 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). | After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation | 
| 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. | After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation | 
| 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. | After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation | 
| 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. | After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation | 
| 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. | After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation |