Phase 4
N=46
Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort
Contact Lens Discomfort · Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT03682809 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Contact Lens Symptoms — 20.41; 18.92; 12.86; 17.92 Score on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Systane Complete (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Contact Lens Symptoms |
20.41; 18.92; 12.86; 17.92; 10.91; 10.38 | — |
| SECONDARY End of Day Eye Comfort |
10.27; 9.67; 7.55; 9.29 | — |
| SECONDARY Corneal Staining |
1.73; 1.63; 1.22; 0.92; 1.18; 0.92 | — |
| SECONDARY Schirmer's I Test Without Anesthetic |
15.68; 20.88; 15.41; 18.30 | — |
| SECONDARY Tear Break-Up Time (TBUT) |
7.70; 8.50; 8.57; 8.80 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03682809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.