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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 79
- Primary Endpoint
- Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1
Study Overview
Brief Summary
A study to evaluate the tolerability and acceptability of an investigational eye drop formulation in patients with Dry Eye Disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
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 followed by 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks.
Intervention: Carboxymethylcellulose Sodium Based Eye Drops (Drug)
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 followed by 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks.
Intervention: Systane® Gel Drops (Drug)
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 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.
Intervention: Carboxymethylcellulose Sodium Based Eye Drops (Drug)
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 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.
Intervention: Systane® Gel Drops (Drug)
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 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.
Intervention: Carboxymethylcellulose Sodium Based Eye Drops (Drug)
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 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.
Intervention: Genteal® Lubricant Gel Drops (Drug)
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 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks.
Intervention: Carboxymethylcellulose Sodium Based Eye Drops (Drug)
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 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks.
Intervention: Genteal® Lubricant Gel Drops (Drug)
Outcomes
Primary Outcomes
Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
- 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))
- 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)
- 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))
- 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))
- 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)
- 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))
- 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))
- 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)
- 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))
- 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)
- 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)
- 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)
- 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)