Abstract
Purpose :
To investigate the safety profile of a preservative free new tear substitute containing sodium hyaluronate (0.2%) and hydrocortisone (0.001%) in rabbit eye. A retrospective observation of intraocular pressure (IOP) was also performed in patients treated with the same formulation.
Methods :
New Zealand albino rabbits were used in the present study. All the animals were treated according to the ARVO Statement for the Use of Animals in Ophthalmic and Vision Research. A topical treatment with the novel formulation was carried out for 4 weeks (4 times/day, 30ml/eye). The potential ocular irritancy and/or damaging effects of the formulations were evaluated according to a modified Draize test. Congestion, swelling, and discharge of the conjunctiva were graded on a scale from 0 to 3, and iris hyperemia was graded on a scale from 0 to 4.Intraocular pressure (IOP) was measured before every week using a tonometer. A retrospective observation of intraocular pressure (IOP) was also performed in 40 patients with dry eye disease (DED) treated with the new formulation (tid), for 6 months. Values were recorded after 2 or 3 hours from the last instillation of the eyedrop.
Results :
The new preservative free formulation was well tolerated in the rabbit eye and the score for each parameter was negative at all time of observations. No significant differences on IOP values at any time were observed after treatment with the new formulation. The retrospective clinical observation did not show significant changes in terms of IOP in DED patients treated with the novel formulation compared to baseline values (16±3vs 15±2 mmHg).
Conclusions :
These data demonstrated that the novel formulation based on sodium hyaluronate and low concentration of hydrocortisone is well tolerated and safe in rabbit eye and in humans since and it does not affect the IOP. These findings suggest that the use of a substitute tear with low concentrations of hydrocortisone to manage DED is a safe option. Further studies are necessary to confirm our results.
This is a 2020 ARVO Annual Meeting abstract.