Phase 4
N=73
Direct Application of Systane Complete to Contact Lenses
Dry Eye · Contact Lens Complication
Bottom Line
View on ClinicalTrials.gov: NCT03848221 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Difference in Ocular Surface Damage as Measured by the Brien Holden Vision Institute (BHVI Grading Scale) at Two Weeks — 0.44; 1.08; 0.83 Score on a Scale — p=0.30
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Systane Complete (Drug); Sensitive Eyes Rewetting Drops (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Ocular Surface Damage as Measured by the Brien Holden Vision Institute (BHVI Grading Scale) at Two Weeks |
0.44; 1.08; 0.83 | 0.30 |
| SECONDARY Identifying Contact Lens (CL) Participants With Dry Eye Disease (DED), as Measured by the Contact Lens Dry Eye Questionnaire-4 Items (CLDEQ-4) Between Two Weeks and Baseline. |
-8.52; -8.25; -11.50 | 0.0002 sig |
Summary
A common first line treatment for patients with dryness symptoms or contact lens discomfort is the application of artificial tears or rewetting drops, respectively. Rewetting drops are specifically formulated for use with contact lenses while artificial tears are indicated for dry eye. Modern rewetting drops and artificial tears have similar formulations with similar preservatives, preservatives that have been shown to be compatible with contact lenses. While rewetting drops and artificial tears are regulated under different U.S. Food & Drug Administration policies, artificial tears are not specifically indicated for direct use with contact lenses. Nevertheless, clinicians commonly prescribe artificial tears to contact lens wearers likely because newer formulations of artificial tear have the potential to outperform available rewetting drops. The safety and efficacy of using artificial tears with contact lenses for the treatment of discomfort is supported by Caffery and Josephson and Ozkan and Papas who found that artificial tears significantly reduces dryness symptoms in contact lens wearers. Thus, the purpose of this study is to test the safety of directly applying a new artificial tear, Systane Complete, to the contact lens wearing eye and its ability to alleviate symptoms while wearing contact lenses during the day.
Eligibility Criteria
Inclusion Criteria
- Daily disposable contact lens wearers
- 20/30 visual acuity or better
- Self-report contact lens discomfort
- Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores ≥ 12
Exclusion Criteria
- Other contact lens modalities/wear schedules (e.g., two week and monthly replacement CLs, gas permeable CLs)
- Non-compliant daily disposable contact lens wearers
- Systemic health conditions that alter tear film physiology (e.g., primary and secondary Sjögren's syndrome)
- History of ocular surgery within the past 12 months
- History of severe ocular trauma
- History of active ocular infection or inflammation
- Isotretinoin-derivatives use
- Ocular medication use
- Pregnant or breast feeding
Data sourced from ClinicalTrials.gov (NCT03848221). 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.