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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01294384




Registration number
NCT01294384
Ethics application status
Date submitted
10/02/2011
Date registered
11/02/2011
Date last updated
16/04/2019

Titles & IDs
Public title
Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease
Scientific title
Secondary ID [1] 0 0
10078X-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry Eye Syndromes 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - carboxymethylcellulose sodium based New Eye Drop Formulation 1
Treatment: Drugs - carboxymethylcellulose sodium based New Eye Drop Formulation 2
Treatment: Drugs - carboxymethylcellulose sodium based Eye Drops

Experimental: New Eye Drop Formulation 1 - 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.

Experimental: New Eye Drop Formulation 2 - 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.

Active Comparator: Refresh Tears® - 1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.


Treatment: Drugs: carboxymethylcellulose sodium based New Eye Drop Formulation 1
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.

Treatment: Drugs: carboxymethylcellulose sodium based New Eye Drop Formulation 2
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.

Treatment: Drugs: carboxymethylcellulose sodium based Eye Drops
1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline, Day 90
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline, Day 90
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline, Day 90
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline, Day 90
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline, Day 90
Secondary outcome [5] 0 0
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).
Timepoint [5] 0 0
Baseline, Day 90
Secondary outcome [6] 0 0
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).
Timepoint [6] 0 0
Baseline, Day 90
Secondary outcome [7] 0 0
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).
Timepoint [7] 0 0
Baseline, Day 90

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- Randwick
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Newfoundland and Labrador

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01294384
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications