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This study sought to determine whether daily irrigation with sterile saline solution during silicone hydrogel (SiH) contact lens continuous wear (CW) could improve ocular surface integrity and reduce the risk of adverse events.
The purpose of this study was to determine whether daily irrigation with sterile saline solution during silicone hydrogel (SiH) contact lens 30-day continuous wear (CW) can mitigate increases in corneal epithelial permeability (Pdc) and reduce the risk of mechanical, contact lens-induced, inflammatory, and overall adverse events. 161 non-contact lens wearers were fit with SiH contact lenses and randomized to either a treatment (n = 81) or control (n = 80) group for 30-day CW. Subjects in the treatment group irrigated every morning and whenever dryness symptoms occurred; subjects in the control group did not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30-day SiH CW, No Daily Irrigation | Other | Control group subjects wore SiH lenses for 30-day CW under normal clinical practice guidelines with no daily morning irrigation of the eyes with sterile saline solution |
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| 30-day SiH CW, Daily Irrigation | Other | Treatment group subjects wore SiH lenses for 30-day CW under normal clinical practice guidelines, and also irrigated the eyes with sterile saline solution every morning upon awakening |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily irrigation | Drug | Daily morning irrigation of the eye with sterile, borate-buffered, saline solution (Unisol 4) and gentle nudging of the lens to promote solution flow beneath the lens |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal epithelial permeability (Pdc) at Baseline | Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec at baseline with no contact lenses | Baseline |
| Corneal epithelial permeability (Pdc) Post-1-Day CW | Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec after 1 night of contact lens CW | Post-1-Day CW of SiH contact lenses |
| Corneal epithelial permeability (Pdc) Post-30-Day CW | Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec after 30 nights of contact lens CW | Post-30-Day CW of SiH contact lenses |
| Risk of adverse events | Odds ratios (OR) for adverse events: contact lens-induced, mechanically-induced, inflammatory, and overall | Post-30-day CW of SiH contact lenses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meng C Lin, OD, PhD, FAAO | University of California, Berkeley | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24425854 | Background | Lin MC, French HM, Graham AD, Sanders TL. Effects of daily irrigation on corneal epithelial permeability and adverse events with silicone hydrogel contact lens continuous wear. Invest Ophthalmol Vis Sci. 2014 Feb 10;55(2):776-83. doi: 10.1167/iovs.13-13508. |
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161 non-contact lens wearers were fit with silicone hydrogel (SiH) contact lenses and randomized to either a treatment (n = 81) or control (n = 80) group for 30-day continuous wear (CW). Subjects in the treatment group irrigated every morning and whenever dryness symptoms occurred; subjects in the control group did not.
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Research optometrists conducting eye examinations and technicians conducting fluorometry measurements did not know whether a given subject was in the treatment (irrigating) or control (non-irrigating) group.
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| 30-day SiH CW | Device | 30-day continuous wear of silicone hydrogel contact lenses |
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