This was a randomised investigator-masked parallel group interventional trial. The history of amendments is provided in the website https://clinicaltrials.gov/ct2/show/NCT02219204 . These study arms were involved: (1) A common comparative group with only Systane Ultra (Alcon, Fortworth, Texas, USA) eye-drop (artificial tear (AT)) (n=50), (2) Systane Ultra with AC (n=50) and (3) Systane Ultra and HB treatment (n=50). The duration from baseline to follow-up assessment was 4 weeks. All participants were screened and recruited within 1 year. The study adhered to Consolidated Standards of Reporting Trials guidelines.
Systane ultra
Manufactured by Alcon
Sourced in United States, Switzerland
Systane Ultra is a sterile, preservative-free eye drop solution formulated to provide temporary relief of dry eye symptoms. It contains a unique combination of ingredients designed to help restore the eye's natural tear film.
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Lab products found in correlation
Envisu r2000 sd oct device, by Bioptigen (2 mentions)
Tropicamide, by Akorn (2 mentions)
Systane balance, by Alcon (2 mentions)
Systane complete, by Alcon (1 mentions)
Sd oct device, by Bioptigen (1 mentions)
Envisu r2200, by Bioptigen (1 mentions)
Spectral domain ophthalmic imaging system, by Bioptigen (1 mentions)
Tobradex, by Alcon (1 mentions)
Econopred plus, by Alcon (1 mentions)
Vigamox, by Alcon (1 mentions)
Spectralis, by Heidelberg Engineering (1 mentions)
Invivovue diver 2, by Bioptigen (1 mentions)
Envisu r2300, by Bioptigen (1 mentions)
Sq detector, by Waters Corporation (1 mentions)
Luna c18 2 100 column, by Phenomenex (1 mentions)
Genteal, by Novartis (1 mentions)
Proparacaine hcl, by Alcon (1 mentions)
Artelac rebalance, by Bausch & Lomb (1 mentions)
Cationorm, by Santen (1 mentions)
Systane, by Alcon (1 mentions)
24 protocols using systane ultra
1
Comparative Evaluation of Dry Eye Treatments
2
Tear LLT Measurements with Eye Drops
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Tear LLT measurements were taken after use of two different eye drops. Systane Complete® (Alcon Laboratories, Inc., Fort Worth, TX, USA) was utilized as the emollient containing eye drop and contains propylene glycol 0.6% (lubricant), and inactive ingredients including boric acid, dimyristoyl phosphatidylglycerol, edatate disodium, hydroxypropyl guar (HPG), mineral oil, polyoxl 40 stearate, polyquaternium-1 0.001%, sorbitan tristearate, sorbitol and purified water. This nanoemulsion contains HPG, which allows cross-linking of the eye drop on the ocular surface after instillation, and subsequently improves contact between the drop and the eye.22 (link), 23 Systane Ultra® (Alcon Laboratories, Inc., Fort Worth, TX, USA) was used as the non-emollient containing eye drop, and contains polyethylene glycol 400 0.4% (lubricant), and propylene glycol 0.3% (lubricant), as well as the inactive ingredients aminomethylpropanol, boric acid, HPG, polyquaternium-1 0.001%, potassium chloride, purified water, sodium chloride, and sorbitol. Both drops contain hydrochloric acid and sodium hydroxide for pH adjustment.
3
Retinal Thickness Measurement in Mice
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Mice were anesthetized and their pupils were dilated. Artificial tears (Systane Ultra, Alcon) were used to maintain corneal hydration and clarity. The retinal thickness was measured using a SD-OCT device (Bioptigen) following a previously established method (60 (link)). For details, see SI Appendix .
4
Retinal OCT Imaging in Mice
5
Spectral-Domain OCT Analysis of Mouse Retina
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Spectral-domain optical coherence tomography (SD-OCT) was performed separately on each eye using an Envisu R2000 SD-OCT device (Bioptigen, Durham, NC). The pupils were dilated by applying 0.5% tropicamide to the cornea. The mice were anesthetized by an intraperitoneal injection of a mixture of ketamine (70 mg/kg) and xylazine (14 mg/kg), and local anesthesia was performed with a drop of oxybuprocaine (0.4% cebesine) on the cornea. Corneal hydration was maintained with Systane Ultra (Alcon, Fort Worth, TX) lubricant eye drops. Animal preparation and image acquisition were performed as previously described27 (link). Analyses were performed using a rectangular scanning protocol (1.4 mm × 1.4 mm with 1000 A-scans per B-scan × 100 B-scans) while centered on the optic nerve. The thickness of the inner nuclear layer (INL), outer nuclear layer (ONL), and photoreceptor segments (PS = IS + OS) was measured and expressed in arbitrary units using ImageJ software. Twenty measurements were performed per analysis and averaged for both eyes.
6
Postoperative Regimes for Senile Cataract
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Participants were recruited from the Cataract Service of the UHA in a consecutive-if-eligible basis. Eligibility criteria included diagnosis of senile cataract. Exclusion criteria for all study groups included: diagnosis or evidence of dry-eye-disease (DED), IOP-lowering medications, former incisional surgery, former diagnosis of corneal disease, diabetes, autoimmune or mental diseases. By means of a custom computer randomization program, all participants were randomly assigned to three study groups according to the postoperative regime that was prescribed: a) Study group 1 (SG1) received a fixed combination of tobramycin and dexamethasone (FCTD), (Tobradex, Alcon, Greece) quid for 3 weeks and, additionally Systane Ultra, Alcon, Greece quid, for 6 weeks, b) Study group 2 (SG2) received Tobradex quid for 3 weeks and, additionally Hylocomod quid, for 6 weeks, and, c) Control Group (CG) received only Tobradex quid for 3 weeks.
7
Efficacy of Systane Ultra and Chinese Herbal Medicine for Dry Eye
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All participants used Systane ultra (Alcon) eye-drops four times a day. AC patients undergone twice weekly AC over eight sessions, and HB patients used ‘qi ju gan lu yin’ twice daily. (Details of treatments are provided in online esupplementary materials, etable 2 and supplementary efigure 2 ).
8
Postoperative Topical Treatment for Corneal Surgery
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All patients received the same postoperative topical treatment, in the form of antibiotic eye drops (0.5% moxifloxacin hydrochloride; Vigamox, Alcon Laboratories, Inc., Fort Worth, TX, USA), steroidal eye drops (1% prednisolone acetate; Econopred Plus, Alcon Laboratories, Inc.) and lubricating eye drops (Systane Ultra, Alcon Laboratories, Inc.). All topical eye drops were instilled five times daily for the first week and three times daily for the second week. Bandage contact lenses were removed 24 hr after surgery, during the first follow‐up visit. All patients were followed up at postoperative day 1, week 1, as well as months 1, 3 and 6; however, corneal topography was measured only at postoperative month 6.
9
In Vivo GFP Expression Quantification
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GFP expression was evaluated by fundus imaging in vivo. Fundus images were obtained using confocal scanning laser ophthalmoscopy (cSLO; Spectralis; Heidelberg Engineering, Franklin, MA). Animals were first anesthetized, and the pupils were dilated. The cornea was lubricated with Systane Ultra (Alcon, Fort Worth, TX). An eyelid speculum was inserted to keep the eye open during imaging. The fundi of animal eyes were viewed using a 55° wide-field lens in blue auto-fluorescence mode with a 488 nm laser to capture the high fluorescence region. To quantify and compare GFP expression in rabbit retina, we used an expression index defined as GFP positive area times GFP fluorescence intensity in the medullated retinal region, which was estimated from fundus photographs. Specifically, GFP pixel area and intensity were measured along the entire medullated regions in fundus micrographs using an intensity threshold method with ImageJ software (http://imagej.nih.gov/ij/ ), as previously described.9 (link) In brief, the analysis used photographs with the entire medullated regions around the optic disc. An intensity threshold was applied by ImageJ software to select GFP-positive areas from background signals. Then the software measured the GFP pixel area and intensity. A larger expression index indicates stronger GFP expression and/or larger AAV GFP-transduced retinal area.
10
Retinal Layer Thickness Analysis in Mice
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Mice were anesthetized (Ketamine at 20 mg/ml and Xylazine at 1.17 162 mg/ml) and their pupils dilated with 10% phenylephrine and 0.5% tropicamide provided as eye drops (Systane Ultra, Alcon). OCT was performed for mouse retinas with the spectral domain (SD) ophthalmic imaging system as described previously (Jagodzinska et al., 2017 (link)). Thickness of retinal layers was measured manually with ImageJ image processing program (National Institute of Health) at 0.3 mm distance from the optic nerve.
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