TY - JOUR
T1 - Allogeneic Serum Eye Drops
T2 - A Randomized Clinical Trial to Evaluate the Clinical Effectiveness of Two Drop Sizes
AU - Vermeulen, Christie
AU - van der Burg, Lars L.J.
AU - van Geloven, Nan
AU - Eggink, Catharina A.
AU - Cheng, Yanny Y.Y.
AU - Nuijts, Rudy M.M.A.
AU - Wisse, Robert P.L.
AU - van Luijk, Chantal M.
AU - Nieuwendaal, Carla
AU - Remeijer, Lies
AU - van der Meer, Pieter F.
AU - de Korte, Dirk
AU - Klei, Thomas R.L.
N1 - Funding Information:
This work was supported by Sanquin Blood Bank. Publication, including the journal’s Rapid Service Fee, was also funded by Sanquin Blood Bank.
Publisher Copyright:
© 2023, The Author(s).
PY - 2023/12/1
Y1 - 2023/12/1
N2 - Introduction: Allogeneic serum from blood donors is starting to be used to treat patients with dry eye disease (DED). However, the optimal dose is not known. We therefore aimed to evaluate the clinical efficaciousness and user-friendliness of micro-sized versus conventional-sized allogeneic serum eye drops (SEDs). Methods: In a randomized trial, patients with DED first receive micro-sized SEDs (7µl/unit) for 1 month, followed by a 1-month washout, before receiving conventional-sized SEDs (50µl/unit) for 1 month; or vice versa. The primary endpoint was the Ocular Surface Disease Index (OSDI) score. Secondary endpoints were tear break-up time (TBT), tear production (TP), and presence of corneal punctate lesions (CP). The user-friendliness of both application systems was also compared. A linear mixed model for cross-over design was applied to compare both treatments. Results: Forty-nine patients completed the trial. The mean OSDI score significantly improved from 52 ± 3 to 41 ± 3 for micro-sized SEDs, and from 54 ± 3 to 45 ± 3 for conventional-sized SEDs. Non-inferiority (margin = 6) of micro-sized SEDs was established. We demonstrate a significant improvement for TBT in case of conventional-sized SEDs and for CP in both treatment groups. TP trended towards an improvement in both treatment groups. The user-friendliness of the conventional drop system was significantly higher. Conclusions: For the first time, non-inferiority of micro-sized allogeneic SEDs was established. The beneficial effect of both SED volumes was similar as measured by the OSDI score. Although user-friendliness of the micro drop system was significantly lower, it is an attractive alternative as it saves valuable donor serum. Trial Registration: ClinicalTrials.gov (NCT03539159).
AB - Introduction: Allogeneic serum from blood donors is starting to be used to treat patients with dry eye disease (DED). However, the optimal dose is not known. We therefore aimed to evaluate the clinical efficaciousness and user-friendliness of micro-sized versus conventional-sized allogeneic serum eye drops (SEDs). Methods: In a randomized trial, patients with DED first receive micro-sized SEDs (7µl/unit) for 1 month, followed by a 1-month washout, before receiving conventional-sized SEDs (50µl/unit) for 1 month; or vice versa. The primary endpoint was the Ocular Surface Disease Index (OSDI) score. Secondary endpoints were tear break-up time (TBT), tear production (TP), and presence of corneal punctate lesions (CP). The user-friendliness of both application systems was also compared. A linear mixed model for cross-over design was applied to compare both treatments. Results: Forty-nine patients completed the trial. The mean OSDI score significantly improved from 52 ± 3 to 41 ± 3 for micro-sized SEDs, and from 54 ± 3 to 45 ± 3 for conventional-sized SEDs. Non-inferiority (margin = 6) of micro-sized SEDs was established. We demonstrate a significant improvement for TBT in case of conventional-sized SEDs and for CP in both treatment groups. TP trended towards an improvement in both treatment groups. The user-friendliness of the conventional drop system was significantly higher. Conclusions: For the first time, non-inferiority of micro-sized allogeneic SEDs was established. The beneficial effect of both SED volumes was similar as measured by the OSDI score. Although user-friendliness of the micro drop system was significantly lower, it is an attractive alternative as it saves valuable donor serum. Trial Registration: ClinicalTrials.gov (NCT03539159).
KW - Allogeneic serum eye drops
KW - Application system
KW - Drop size
KW - Dry eye disease (DED)
KW - Naïve patients with DED
KW - Ocular Surface Disease Index (OSDI)
KW - Randomized clinical trial
U2 - 10.1007/s40123-023-00827-5
DO - 10.1007/s40123-023-00827-5
M3 - Article
SN - 2193-8245
VL - 12
SP - 3347
EP - 3359
JO - Ophthalmology and Therapy
JF - Ophthalmology and Therapy
IS - 6
ER -