Dry Eye Clinical Trial
Official title:
Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort
Verified date | March 2020 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Clinicians commonly use artificial tears off label for treating contact lens (CL) discomfort and the dry eye associated with CLs because new artificial tear formulations have the potential to outperform the available CL rewetting drops. While off-label, McDonald et al. have previously shown that using a common artificial tear, Systane Ultra, before and after CL use is an effective means for treating daily disposable CL wears who have CL discomfort. Recently, a new formulation of artificial tears, Systane Complete, was released to the market. Systane Complete is a unique formulation that has combined elements from both Systane Ultra (indicated for aqueous deficient dry eye) and Systane Balance (indicated for evaporative dry eye) to create an artificial tear with an indication for aqueous deficient, evaporative, and mixed (both aqueous deficient and evaporative) dry eye. Thus, the goal of this study is to determine in a randomized clinical trial if Systane Complete is able to effectively improve the symptoms of patients who have CL discomfort.
Status | Completed |
Enrollment | 46 |
Est. completion date | March 23, 2019 |
Est. primary completion date | March 23, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Self-reported contact lens discomfort - Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores = 12 - Daily disposable contact lens wearer - Best-corrected visual acuity of 20/30 or better Exclusion Criteria: - All other contact lens types (e.g., currently wearing two week or monthly replacement contact lenses or hard contact lenses) - Non-compliant daily disposable contact lens wearers (must regularly replace contact lenses daily) - Systemic health conditions known to alter tear film physiology - History of ocular surgery within the past 12 months - History of severe ocular trauma, active ocular infection, or inflammation - Currently using Accutane or eye medications - Pregnant or breast feeding |
Country | Name | City | State |
---|---|---|---|
United States | Lindenhurst Eye Physicians & Surgeons, P.C. | Babylon | New York |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Southern College of Optometry | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | Alcon Research, Lindenhurst Eye Physicians & Surgeons, PC, Southern College of Optometry |
United States,
McDonald M, Schachet JL, Lievens CW, Kern JR. Systane® ultra lubricant eye drops for treatment of contact lens-related dryness. Eye Contact Lens. 2014 Mar;40(2):106-10. doi: 10.1097/ICL.0000000000000018. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Contact Lens Symptoms | Improvement in contact lens symptoms as measured with the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) and CLDEQ-4 at 2 weeks compared to baseline. The CLDEQ-8 score range is 0 to 37 with 0 being the best score. Subjects were required to have a CLDEQ-8 of at least 12 in order to participate. The CLDEQ-4 is a subset of the CLDEQ-8, and it was also reported because it is a unidimensional measure of ocular discomfort in contact lens wearers. The CLDEQ-4 has a score range of 0 to 18 with 0 being the best score. | Baseline through 2 Weeks | |
Secondary | End of Day Eye Comfort | Improvement in eye symptoms as measured with the Standardized Patient Evaluation of Eye Dryness (SPEED) at 2 weeks compared to baseline. The scale range is 0 to 28 with 0 being the best score. | Baseline through 2 Weeks | |
Secondary | Corneal Staining | Improvement in conjuctivial staining at two weeks compared to baseline using the Brien Holden Vision Institute (BHVI) scale, which measures five regions of the eye on a (0-4) scale (max of 20 per metric). A score 0 is the best possible score. | Baseline through 2 Weeks | |
Secondary | Schirmer's I Test Without Anesthetic | Improvement in tear volume as measured in mm of wetting with a Schirmer's strip at 5 mins at 2 weeks compared to baseline. The score ranges is 0 mm to 35 mm with 35 mm being the best score. | Baseline through 2 Weeks | |
Secondary | Tear Break-Up Time (TBUT) | Improvement in tear break up time as measured with a slit-lamp biomicroscope and sodium fluorescein in seconds at 2 weeks compared to baseline. Scores range for 0 to 60 seconds with 60 seconds being the best score. | Baseline through 2 Weeks |
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