Sight Sciences announced in a press release that the manuscript detailing 24-month results from Stage 3 of the SAHARA randomized controlled trial (RCT) has been published ahead of print by Optometry and Vision Science and is available online in pre-publication format.

According to Sight Sciences, all mean signs and symptoms remained statistically significantly better than the study baseline at all timepoints 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, the company said. 

Sight Sciences reports that the SAHARA RCT 24-month Stage 3 results are as follows:

• 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 2 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 vs 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 eye drops 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 12.²

According to Sight Sciences, 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 timepoints. Following the first 2 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%.

References

Paper Reference: Hovanesian J, Ayres BD, Bloomenstein MR, et al. Durability of the TearCare treatment effect in subjects with dry eye disease: Stage 3 of the Sahara randomized controlled trial. Optom Vis Sci. Published online July 28, 2025. doi:10.1097/OPX.0000000000002278

1. Ayres BD, Bloomenstein MR, Loh J, 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. Published 2023 Dec 18. doi:10.2147/OPTH.S442971

2. Ayres 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. Published 2024 May 28. doi:10.2147/OPTH.S464379