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A two-week clinical evaluation of the safety of Systane Ultra in contact lens-wearing patients.

Kading D - Clin Ophthalmol (2010)

Bottom Line: After 14 days, biomicroscopy results, visual acuity, and corneal staining score were recorded.For subjects using Systane((R)) Ultra, no statistically significant change was detected in visual acuity (= 0.7667) or corneal staining score (P = 1.000).For subjects using the control solution, the change in visual acuity (P = 0.0011, mean difference = 1.70 +/- 3.22 standard deviation) was not clinically relevant and there was no significant change in corneal staining score (P = 0.5413).

View Article: PubMed Central - PubMed

Affiliation: Specialty Eyecare Group, 11830 NE 128th St, Suite 1, Kirkland, WA, USA. doctorkading@gmail.com

ABSTRACT

Objective: To evaluate the safety of Systane((R)) Ultra Lubricant Eye Drops (test solution) in contact lens wearers. A currently marketed contact lens rewetting drop was the control solution.

Participants: This investigator- and patient-masked, single-site, randomized, and prospective study involved 45 successful contact lens wearers.

Methods: Eligible subjects' baseline biomicroscopy findings, visual acuity, and corneal staining score were recorded. Subjects received either the test or control solution with masked labeling. Subjects were instructed to instill their assigned solution in both eyes: 15 minutes prior to lens insertion, at least one drop during lens wear and another drop immediately following lens removal. After 14 days, biomicroscopy results, visual acuity, and corneal staining score were recorded.

Results: No adverse events were documented for either the test or the control solution. For subjects using Systane((R)) Ultra, no statistically significant change was detected in visual acuity (= 0.7667) or corneal staining score (P = 1.000). For subjects using the control solution, the change in visual acuity (P = 0.0011, mean difference = 1.70 +/- 3.22 standard deviation) was not clinically relevant and there was no significant change in corneal staining score (P = 0.5413).

Conclusions: This clinical study provided evidence of safety and compatibility of Systane Ultra Lubricant Eye Drops in contact lens wearers.

No MeSH data available.


Corneal staining was graded in each of five corneal zones using the NEI grid (superior, nasal, central, inferior, temporal).
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f1-opth-4-027: Corneal staining was graded in each of five corneal zones using the NEI grid (superior, nasal, central, inferior, temporal).

Mentions: Subjects were assessed for corneal staining and any abnormal findings associated with the lids, cornea, and conjunctiva. Corneal staining was graded using the NEI staining grid in which a score of 0–3 (0 = normal and 3 = severe) was assigned to each of five corneal regions (nasal, central, temporal, inferior, and superior) with a maximum total score of 15 (Figure 1).10


A two-week clinical evaluation of the safety of Systane Ultra in contact lens-wearing patients.

Kading D - Clin Ophthalmol (2010)

Corneal staining was graded in each of five corneal zones using the NEI grid (superior, nasal, central, inferior, temporal).
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2819766&req=5

f1-opth-4-027: Corneal staining was graded in each of five corneal zones using the NEI grid (superior, nasal, central, inferior, temporal).
Mentions: Subjects were assessed for corneal staining and any abnormal findings associated with the lids, cornea, and conjunctiva. Corneal staining was graded using the NEI staining grid in which a score of 0–3 (0 = normal and 3 = severe) was assigned to each of five corneal regions (nasal, central, temporal, inferior, and superior) with a maximum total score of 15 (Figure 1).10

Bottom Line: After 14 days, biomicroscopy results, visual acuity, and corneal staining score were recorded.For subjects using Systane((R)) Ultra, no statistically significant change was detected in visual acuity (= 0.7667) or corneal staining score (P = 1.000).For subjects using the control solution, the change in visual acuity (P = 0.0011, mean difference = 1.70 +/- 3.22 standard deviation) was not clinically relevant and there was no significant change in corneal staining score (P = 0.5413).

View Article: PubMed Central - PubMed

Affiliation: Specialty Eyecare Group, 11830 NE 128th St, Suite 1, Kirkland, WA, USA. doctorkading@gmail.com

ABSTRACT

Objective: To evaluate the safety of Systane((R)) Ultra Lubricant Eye Drops (test solution) in contact lens wearers. A currently marketed contact lens rewetting drop was the control solution.

Participants: This investigator- and patient-masked, single-site, randomized, and prospective study involved 45 successful contact lens wearers.

Methods: Eligible subjects' baseline biomicroscopy findings, visual acuity, and corneal staining score were recorded. Subjects received either the test or control solution with masked labeling. Subjects were instructed to instill their assigned solution in both eyes: 15 minutes prior to lens insertion, at least one drop during lens wear and another drop immediately following lens removal. After 14 days, biomicroscopy results, visual acuity, and corneal staining score were recorded.

Results: No adverse events were documented for either the test or the control solution. For subjects using Systane((R)) Ultra, no statistically significant change was detected in visual acuity (= 0.7667) or corneal staining score (P = 1.000). For subjects using the control solution, the change in visual acuity (P = 0.0011, mean difference = 1.70 +/- 3.22 standard deviation) was not clinically relevant and there was no significant change in corneal staining score (P = 0.5413).

Conclusions: This clinical study provided evidence of safety and compatibility of Systane Ultra Lubricant Eye Drops in contact lens wearers.

No MeSH data available.