Disease aetiology-based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple-masked and active-controlled clinical trial.

PURPOSE: To assess the safety and efficacy of multi-ingredient sacha inchi microemulsion (SIME) eye drops designed to target (1) tear film instability, (2) tear hyperosmolarity, and (3) ocular surface damage and inflammation in moderate or severe dry eye. METHODS: This randomized, quadruple-masked, active-controlled parallel study in 64 adult patients comprised three parts. Part 1 (n = 3): one eye was treated with SIME for one day. Part 2 (n = 9): randomized eyes were treated with SIME and 0.2% hyaluronic acid (HA) control eye drops 3 times a day for 10 days. Part 3 (n = 26 + 26): randomized treatment was applied on both eyes 3 times a day for 30 days. OSDI change was tested for superiority of SIME over HA. Ocular assessments were performed at baseline and after the last dose. RESULTS: Both treatments were well tolerated without adverse device effects. Tear film break-up time (p = 0.0025) and ocular protection index (p = 0.0026; change vs. HA, p = 0.047) increased significantly with SIME after 30 days. Tear osmolarity decreased more in SIME than in the HA group and significantly with both eye drops in hyperosmolar subgroups. Corneal (p = 0.014) and nasal conjunctival staining (p = 0.043) were reduced with SIME in per-protocol patients (n = 24). Conjunctival (p = 0.001) and lid redness (p = 0.012) decreased with SIME in all patients (n = 26). Symptoms decreased by about 25 OSDI units with both treatments (p < 0.0001) and with nonsignificant difference between treatments. CONCLUSIONS: Sacha inchi microemulsion (SIME) proved safe and efficacious in improving each aetiologic factor for dry eye as revealed through objective tests. Hyperosmolar stress dominating blink cycles must be disrupted by biophysical protection of the ocular surface to facilitate resolution of cellular damage and inflammation, and relief of ocular symptoms.

Effects of a sea buckthorn oil spray emulsion on dry eye.

PURPOSE: To investigate the effects of a sea buckthorn oil and sodium hyaluronate-containing eyelid spray emulsion (SB spray) on dry eye. METHODS: A randomized controlled study was carried out. Adults (25-70 years) with Ocular Surface Disease Index (OSDI) ≥20 and moderate or severe dryness, burning or grittiness of the eyes were included. In study part one (n = 2), SB spray was used on both closed eyelids four times in one day. In part two (n = 10), SB spray was used on one randomized eyelid, and a commercial reference spray on the other for nine days. In part three (n = 40), eyes were randomized to one eye receiving SB spray and an untreated control for 1.5 months. Dry eye tests were carried out at baseline, during, and at the end of each study section. Symptoms were recorded in questionnaires and daily logs. RESULTS: In part one, the SB spray was well tolerated. In part two, OSDI decreased significantly (P = 0.022) in the SB spray eye compared to the reference spray, indicating a beneficial effect on symptoms. In part three, OSDI in the SB spray eye decreased significantly compared to the untreated control (P = 0.0007). The scores for dryness at the study end were lower in the SB spray eye compared to control (P = 0.0070). Symptom sums and frequencies of dryness (sum P = 0.0046, frequency P = 0.0016) and watering (sum P = 0.0003, frequency P = 0.013) in the daily logs were lower in the eye treated with SB spray. CONCLUSIONS: SB spray on closed eyelids relieved the symptoms of dry eye.