Safety and Effectiveness of Iota-Carrageenan Eye Drops for the Treatment of Dry Eye Disease

PurposeThe aim of this clinical investigation was to evaluate the safety and effectiveness of iota-carrageenan (I-C) eye drops in the treatment of mild-to-moderate dry eye disease (DED). MethodsIn this prospective, single arm, open label clinical investigation, thirty adult participants with mild-to-moderate DED applied I-C eye drops three times daily for four weeks. Before start and after end of treatment, participants rated DED symptoms (foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia), both after exposure to a normal controlled environment (NCE) and to an adverse controlled environment (ACE). Additional endpoints were changes in ocular surface disease index (OSDI), Change in Dry Eye Symptoms Questionnaire (CDES-Q), corneal and conjunctival surface damage, tear film break-up time, tear evaporation and production. Tolerability was assessed by participants at start and end of treatment. Safety, including visual acuity and intraocular pressure, was monitored throughout the investigation. ResultsAfter four weeks of treatment with I-C eye drops, the mean total DED score after ACE was significantly reduced by -11.89 points (95% CI: -15.11, -8.67), p<0.001. The mean score reduction between baseline and final visit after NCE was slightly less pronounced, with -8.07 points (95% CI: -10.71; -5.43), p<0.001. The vast majority of participants (93% after ACE and 89% after NCE exposure) recorded a reduction in total DED score between baseline and final visit. Mean OSDI score significantly decreased by -7.75 points (95% CI: -10.85, -4.63), p<0.001. ACE-induced deterioration of tear film stability as well as corneal and conjunctival damage were reduced following treatment. All adverse events were mild and transient in nature. 93% of the patients described I-C eye drops as well or very well tolerated. Treatment did not negatively impact any of the safety parameters. ConclusionI-C eye drops are effective, safe and well tolerated. Treatment with I-C eye drops alleviates DED symptoms, stabilizes tear film and protects the ocular surface in patients with mild-to-moderate DED even under adverse environmental conditions. Trial RegistrationNCT06262100.