Mean signs and symptoms for participants in Stage 3 of the SAHARA trial remained statistically significantly better than study baseline at all time points measured up to 24 months.
Sight Sciences, Inc. announced that the manuscript detailing 24-month results from Stage 3 of the SAHARA randomized controlled trial (RCT) has been published ahead of print (PAP) by Optometry and Vision Science (Official Journal of the American Academy of Optometry) and is available online in pre-publication format.
All mean signs and symptoms remained statistically significantly better than the study baseline at all time points measured through the end of the study at 24 months.
The majority (66%) of participants who received treatment for dry eye disease (DED) with the TearCare System (TearCare) at baseline and again at Month 5 required no additional treatment based on pre-defined retreatment criteria.
“These results demonstrate the durability, repeatability, and significant clinical benefits of treatment with TearCare in a landmark device versus drug RCT,” said Paul Badawi, co-founder and CEO of Sight Sciences. “This 24-month endpoint adds to the successful clinical trial results from the previous two stages of the SAHARA trial as well as numerous other studies, expanding a robust body of research evidencing both the effectiveness and durability of interventional dry eye therapy with TearCare. We were pleased to see the 24-month SAHARA RCT data confirm that participants achieved and maintained clinically significant improvements in all signs and symptoms of dry eye disease with one to two TearCare treatments per year.”
“TearCare is delivering something truly rare in dry eye care — relief that’s immediate, powerful, repeatable, and long-lasting,” said lead author John Hovanesian, MD. “Studies of this scale and rigor are uncommon in ocular surface disease, and our findings show that just two TearCare treatments within five months can result in meaningful, lasting improvements for up to two years—a significant step forward for patients living with dry eye disease.”
SAHARA RCT 24-month stage 3 results:
- Tear breakup time (TBUT) remained statistically significantly better than study baseline for all subjects through Month 24 at all timepoints measured with means ranging from 6.29 to 7.13 seconds compared to the baseline of 4.41 seconds (all p<.0001).
- Meibum quality and quantity as measured by Meibomian Gland Secretion Score (MGSS) showed that the improvement from baseline observed at Month 6 following two TearCare treatments, 7.26 to 18.95, was maintained through 24 months for all subjects (means ranging from 17.68 to 18.95, p<.0001 at all timepoints measured versus baseline).
- The number of meibomian glands yielding any liquid (MGYAL) and number of glands yielding clear liquid (MGYCL) also showed clinically meaningful and statistically significant improvement at Month 6 which was sustained throughout the 24-month follow-up period at all timepoints measured, as did anesthetized Shirmer tear scores (STS) as well as conjunctival and corneal staining scores.
- Subject symptoms as assessed by Ocular Surface Disease Index (OSDI), symptom assessment in dry eye (SANDE) and eye dryness score (EDS) for all subjects remained near the values at Month 6 (OSDI 31.9, SANDE 40.2, EDS 39.9) and statistically significantly better than study baseline (OSDI 50.3, SANDE 66.8, EDS 65.1) at all follow-up timepoints measured (p<.0001).
- The study authors suggest that improvements in OSDI, SANDE, and EDS are of particular importance as they represent direct patient feedback about how their eyes feel and how DED is affecting their lives.
- Results from the first 6 months of the SAHARA RCT demonstrated that interventional eyelid procedures enabled by TearCare were superior to twice daily use of Restasis (cyclosporine ophthalmic emulsion 0.05%) prescription eyedrops for the improvement of TBUT, the trial’s primary dry eye signs endpoint and a key measure of tear stability.1 In Stage 2 of the SAHARA RCT, 163 participants who had been randomized and treated with Restasis during Stage 1 were crossed over to TearCare treatment at the 6-month visit. After a single TearCare treatment and discontinuing Restasis, these participants realized additional clinically meaningful improvements in the signs and symptoms of dry eye disease through month 122.
The third and final stage of the SAHARA trial investigated the durability of treatment effect and retreatment interval over 24 months. Participants who were randomized to TearCare treatment in Stage 1, receiving treatment at baseline and Month 5, were followed for 19 months after the second treatment. Ocular signs of TBUT and MGSS as well as symptoms including OSDI were assessed at Months 6, 9, 12, 15, 18 and 24. Retreatment was permitted when TBUT was within 2 seconds of pre-treatment baseline and OSDI increased by 15 points from the previous visit.
For the overall group of 166 subjects that entered this final stage of the trial, all measures of signs and symptoms remained statistically significantly better than study baseline at all time points.
Following the first two treatments at baseline and Month 5, 127 patients did not require additional TearCare treatment for the duration of the study, 32 patients underwent a third treatment, while 7 subjects had a fourth treatment. The median time for a first retreatment was 7 months for those retreated. The 6-month retreatment-free survival probability was 92%.
Authors and Affiliations: Dr. John Hovanesian MD of Harvard Eye Associates, Dr. Brandon D Ayres MD (Private Practice), Dr. Marc R Bloomenstein OD of Schwartz Laser Eye Center, Dr. Jennifer Loh MD of Loh Ophthalmology Associates, Dr. Thomas Chester OD of Cleveland Eye Clinic, Dr. Bobby Saenz OD MS of Rosenberg School of Optometry and Lasik San Antonio, Dr. Julio Echegoyen MD PhD of Gordon Schanzlin New Vision Institute, Dr. Shane R Kannarr OD of Kannarr Eye Care, Tomasita C Rodriguez of Sight Sciences and Jaime E. Dickerson Jr., PhD of Sight Sciences and University of North Texas Health Science Center.
Paper Reference: Hovanesian, J; Ayres, BD; Bloomenstein, MR; Loh, J; Chester, T; Saenz, B; Echegoyen, J; Kannarr, SR; Rodriguez, T; Dickerson, J. Durability of the TearCare treatment effect in subjects with dry eye disease: Stage 3 of the Sahara randomized controlled trial. Optometry and Vision Science ():10.1097/OPX.0000000000002278, July 28, 2025. | DOI: 10.1097/OPX.0000000000002278
References
Ayres BD, Schachter S, Shen Lee B, et al. A randomized, controlled trial comparing TearCare® and cyclosporine ophthalmic emulsion for the treatment of dry eye disease (SAHARA). Clin Ophthalmol. 2023;17:3925-3940.
Ayers BD, Bloomenstein MR, Loh J, et al. Improved signs and symptoms of dry eye disease for Restasis patients following a single TearCare® treatment: phase 2 of the SAHARA study. Clin Ophthalmol. 2024;18:1525-1534