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
1 other identifier
interventional
79
1 country
1
Brief Summary
A study to evaluate the tolerability and acceptability of an investigational eye drop formulation in patients with Dry Eye Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2014
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 22, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
January 4, 2017
CompletedJanuary 4, 2017
November 1, 2016
8 months
January 22, 2015
July 29, 2016
November 7, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (14)
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)
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)
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)
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)
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)
- +9 more secondary outcomes
Study Arms (4)
New Eye Drop Formulation then Systane®
OTHER1 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.
Systane® then New Eye Drop Formulation
OTHER1 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.
Genteal® then New Eye Drop Formulation
OTHER1 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.
New Eye Drop Formulation then Genteal®
OTHER1 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.
Interventions
1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops \[New Eye Drop Formula\] in each eye.
1 to 2 drops of Systane® Gel Drops in each eye.
1 to 2 drops of Genteal® Lubricant Gel Drops in each eye.
Eligibility Criteria
You may qualify if:
- Current use of an artificial tear product
- Visual Acuity of at least 20/40 (while wearing glasses, if necessary).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Azusa, California, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2015
First Posted
May 27, 2015
Study Start
December 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
January 4, 2017
Results First Posted
January 4, 2017
Record last verified: 2016-11