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Clinical Studies Experience

Increased intraocular pressure was the most frequently reported adverse reaction which occurred in 12% of the 391 patients exposed to NAVSTEL® (balanced salt ophthalmic solution) Solution and 11% of the 431 patients exposed to BSS PLUS® Solution.

The following table presents the incidence of patients with IOP ≥ 25 mmHg. IOP lowering medication was not administered until after the first IOP assessment at hour 6 (anterior segment studies) or Day 1 (posterior segment study).

Table 1: Anterior Segment Studies

Treatment NAVSTEL®
N=223
BSS PLUS®
n=220
IOP ≥ 25 mmHg % %
Hour 6 38 35
Day1 17 15
Day3 6 4
Day7 0.5 0
Posterior Segment Study
Treatment NAVSTEL®
N=168
BSS PLUS®
n=176
IOP ≥ 25 mmHg % %
Day1 7 5
Day7 8 8
Day14 10 4
Day 30 4 4

Table 2 presents the most common adverse reactions reported with NAVSTEL® (balanced salt ophthalmic solution) and BSS PLUS.

Table 2

Treatment NAVSTEL®
N=391
BSS PLUS®
n=431
Coded Adverse Reactions % %
Nervous system disorders
  Headache 3 3
Eye disorders
  Ocular Discomfort 5 3
  Macular Edema 4 4
  Conjunctival Hyperemia 4 3
  Dry Eye 3 5
  Iritis 3 1
  Retinal Hemorrhage 3 1
  Vision Blurred 2 1
  Posterior Capsule Opacification 2 3

In the posterior segment surgical study, cataract was reported in 11% of patients exposed to NAVSTEL® (balanced salt ophthalmic solution) , compared to 7% of patients exposed to BSS PLUS® .