Contact Lens Dry Eye Clinical Trial
Official title:
Use of 5.0% Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease in Contact Lens Wearers
Discomfort with contact lens wear is the biggest reason why people stop wearing contact lenses. The investigators believe that inflammation is one of the causes of discomfort, and by blocking the inflammation using lifitegrast, the investigators may be able to relieve some of that discomfort. This study will enroll 50 subjects with contact lens discomfort and will receive lifitegrast to use over a period of approximately 3 months.
The most common reason for contact lens drop out is ocular discomfort, with patients
identifying dryness as the major reason. Currently, many patients with contact lens dry eye
(CLDE) utilize rewetting drops to relieve their symptoms. The problem with rewetting drops is
that they fail as they are transient, and do not address the inflammatory component of
contact lens discomfort. Lifitegrast 5.0% ophthalmic solution was approved and is now
marketed as Xiidra, for the treatment of signs and symptoms of dry eye disease. Lifitegrast
works by reducing inflammation, which suggests that it may be effective in patients with
contact lens dry eye. More specifically, lifitegrast may work by blocking the interaction
between ICAM-1 and LFA-1, which leads to a decrease in the activation and recruitment of
T-cells, and a decrease in pro-inflammatory cytokines.
The safety and efficacy of Xiidra has been studied in four, 12 week clinical trials involving
over 2,100 patients. Each study assessed the effects of Xiidra on symptoms using an Eye
Dryness Score (EDS), which is a visual analogue ranging from 0 (no discomfort) to 100
(maximal discomfort). In two of those studies, lifitegrast was shown to improve symptom
relief at weeks 2, 6, and 12 compared to the placebo
(https://www.xiidra-ecp.com/efficacy-symptom-improvement).
Each of the four clinical trials mentioned above also assessed clinical signs of dry eye
disease, with a particular focus on inferior corneal staining graded on 0.5 unit increments
on a 0 (no staining) to 4 scale (coalescent). In three of the four clinical trials,
lifitegrast reduced inferior corneal staining by week 12, compared to placebo
(https://www.xiidra-ecp.com/efficacy-treating-signs).
Contact lens dry eye is mediated by significant symptoms of ocular surface dryness, in
addition to similar clinical signs of dry eye disease such as corneal staining and
inflammation. Thus, the purpose of this interventional study is to examine the effect of
lifitegrast ophthalmic solution in subjects with contact lens dry eye.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01105624 -
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Rewetting Drops in Subjects With History and Current Complaint of Contact Lens-Related Dry Eye (CLDE)
|
Phase 4 |