Back to resultsSafety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
carboxymethylcellulose sodium based New Eye Drop Formulation 1
carboxymethylcellulose sodium based New Eye Drop Formulation 2
carboxymethylcellulose sodium based Eye Drops
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
Eligibility Criteria
Inclusion Criteria:
- Current use of an artificial tear product at least twice daily for at least 3 months, on average
- Ability/agreement to continue wearing existing spectacle correction (glasses) during study
Exclusion Criteria:
- Anticipated contact lens wear during study or contact lens use within 6 months
- Active ocular infection or allergy
- Use of any topical ophthalmic medications (eg, topical ophthalmic steroids, glaucoma drops) within 2 weeks
- Use of any topical cyclosporine products within 3 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
New Eye Drop Formulation 1
New Eye Drop Formulation 2
Refresh Tears®
Arm Description
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Outcomes
Primary Outcome Measures
Change From Baseline in Ocular Surface Disease Index© (OSDI) Score
The OSDI is a questionnaire consisting of 12 questions assessing severity of dry eye using a 5-point scale where 0=none of the time to 4=all of the time. The total score is the sum of the individual scores normalized (standardized) to a severity scale of 0=no symptoms (best score) to 100=maximum severity (worst score). A negative change from Baseline indicated improvement.
Secondary Outcome Measures
Change From Baseline in Visual Analog (VAS) Symptom Scale: Dryness
The participant rated the severity of their dry eye symptom: dryness using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms.
Percentage of Participants Much Better or Better in Near Visual Acuity (Low Contrast)
Near Visual Acuity was determined using the number of letters read correctly on a low contrast eye chart (gray letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.
Percentage of Participants Much Better or Better in Near Visual Acuity (High Contrast)
Near Visual Acuity was determined using the number of letters read correctly on a high contrast eye chart (black letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.
Change From Baseline in Tear Break-Up Time (TBUT)
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. A positive number change from Baseline indicated improvement.
Change From Baseline in Corneal Staining
The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale where 0=no staining to 5=severe staining over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represented a decrease in corneal staining (improvement).
Change From Baseline in Conjunctival Staining
The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale where 0=no staining to 5=severe staining over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represented a decrease in the severity of conjunctival staining (improvement).
Change From Baseline in Schirmer Test
The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye where Normal=greater than or equal to 10 millimeters (mm) of tears and Dry Eye=less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicated an increase in tears (improvement).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01294384
Brief Title
Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2011 (Actual)
Primary Completion Date
September 25, 2012 (Actual)
Study Completion Date
September 25, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® in patients with dry eye disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
305 (Actual)
8. Arms, Groups, and Interventions
Arm Title
New Eye Drop Formulation 1
Arm Type
Experimental
Arm Description
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
Arm Title
New Eye Drop Formulation 2
Arm Type
Experimental
Arm Description
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
Arm Title
Refresh Tears®
Arm Type
Active Comparator
Arm Description
1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Intervention Type
Drug
Intervention Name(s)
carboxymethylcellulose sodium based New Eye Drop Formulation 1
Intervention Description
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
Intervention Type
Drug
Intervention Name(s)
carboxymethylcellulose sodium based New Eye Drop Formulation 2
Intervention Description
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
Intervention Type
Drug
Intervention Name(s)
carboxymethylcellulose sodium based Eye Drops
Other Intervention Name(s)
Refresh Tears®
Intervention Description
1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Primary Outcome Measure Information:
Title
Change From Baseline in Ocular Surface Disease Index© (OSDI) Score
Description
The OSDI is a questionnaire consisting of 12 questions assessing severity of dry eye using a 5-point scale where 0=none of the time to 4=all of the time. The total score is the sum of the individual scores normalized (standardized) to a severity scale of 0=no symptoms (best score) to 100=maximum severity (worst score). A negative change from Baseline indicated improvement.
Time Frame
Baseline, Day 90
Secondary Outcome Measure Information:
Title
Change From Baseline in Visual Analog (VAS) Symptom Scale: Dryness
Description
The participant rated the severity of their dry eye symptom: dryness using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms.
Time Frame
Baseline, Day 90
Title
Percentage of Participants Much Better or Better in Near Visual Acuity (Low Contrast)
Description
Near Visual Acuity was determined using the number of letters read correctly on a low contrast eye chart (gray letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.
Time Frame
Baseline, Day 90
Title
Percentage of Participants Much Better or Better in Near Visual Acuity (High Contrast)
Description
Near Visual Acuity was determined using the number of letters read correctly on a high contrast eye chart (black letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.
Time Frame
Baseline, Day 90
Title
Change From Baseline in Tear Break-Up Time (TBUT)
Description
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. A positive number change from Baseline indicated improvement.
Time Frame
Baseline, Day 90
Title
Change From Baseline in Corneal Staining
Description
The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale where 0=no staining to 5=severe staining over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represented a decrease in corneal staining (improvement).
Time Frame
Baseline, Day 90
Title
Change From Baseline in Conjunctival Staining
Description
The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale where 0=no staining to 5=severe staining over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represented a decrease in the severity of conjunctival staining (improvement).
Time Frame
Baseline, Day 90
Title
Change From Baseline in Schirmer Test
Description
The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye where Normal=greater than or equal to 10 millimeters (mm) of tears and Dry Eye=less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicated an increase in tears (improvement).
Time Frame
Baseline, Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current use of an artificial tear product at least twice daily for at least 3 months, on average
Ability/agreement to continue wearing existing spectacle correction (glasses) during study
Exclusion Criteria:
Anticipated contact lens wear during study or contact lens use within 6 months
Active ocular infection or allergy
Use of any topical ophthalmic medications (eg, topical ophthalmic steroids, glaucoma drops) within 2 weeks
Use of any topical cyclosporine products within 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Randwick
State/Province
New South Wales
Country
Australia
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
25931807
Citation
Simmons PA, Liu H, Carlisle-Wilcox C, Vehige JG. Efficacy and safety of two new formulations of artificial tears in subjects with dry eye disease: a 3-month, multicenter, active-controlled, randomized trial. Clin Ophthalmol. 2015 Apr 15;9:665-75. doi: 10.2147/OPTH.S78184. eCollection 2015.
Results Reference
background
Learn more about this trial
Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease
We'll reach out to this number within 24 hrs