This was a prospective, randomized, double-masked study conducted at a single center in Mexico, in which 61 patients with
dry eye/
conjunctivitis were assigned to progressive lacrimal occlusion with
collagen and
silicone plugs or a
sham procedural group. Outcome variables included total and individual
dry eye and
conjunctivitis symptom scores, moisturizing agent usage, best-corrected visual acuity, ocular comfort level, visual performance, corneal/conjunctival
fluorescein staining, and incidence of adverse events.
RESULTS: Total
dry eye and conjunctival symptom scores were reduced by 43.7 and 33.7%, respectively 2 weeks after occlusion of all four lacrimal canaliculi with
collagen plugs, increasing to 77.4 and 72.1% 2 weeks later following superior canalicular occlusion of both eyes with
silicone plugs and inferior placement of
collagen plugs. At the 8-week visit (4 weeks after
silicone plug implantation of the inferior canaliculi of both eyes), the reduction in total
dry eye and conjunctival symptom scores further increased to 94.2 and 93.0%, respectively, accompanied by a marked decline in each of the seven individual symptom scores (dryness, watery eyes,
itching, burning,
foreign body, fluctuating vision, and
light sensitivity). In concert with these changes, moisturizing agent usage and corneal/conjunctival
fluorescein staining decreased in a progressive fashion over the 8-week study period, and best-corrected visual acuity, ocular comfort, and visual performance improved in the absence of any treatment-related adverse events except for one case of
epiphora. The response of patients to lacrimal occlusion can be sharply contrasted with the
sham procedure group, which remained relatively unchanged from baseline at each of the study visits.
CONCLUSIONS: