Introduction

Meibomian gland dysfunction (MGD) is one of the leading causes of evaporative dry eye. The phase I of the SAHARA study compared the effectiveness of localized heat therapy, gland expression and lid debridement with cyclosporine 0.05% ophthalmic emulsion for six months.

Aim

To determine the signs and symptoms of dry eye disease (DED) six months after a single treatment with Localized Heat Therapy (LHT) in patients previously treated for six months with twice-daily cyclosporine (0.05%) ophthalmic emulsion (CsA).

Patient Profile

• Patients experiencing dry eye symptoms in the 3–6 months before the screening and being treated with artificial tears or lubricants to relieve the symptoms.
• All patients had an anesthetized Schirmer score of >5 mm and <15 mm, moderate-to- severe ocular surface disease index (OSDI) score (23–79), TBUT between 1 and 7 seconds), a meibomian gland secretion score (MGSS) of <12, 15 expressible meibomian glands in each lower lid, and best-corrected visual acuity (BCVA) at least 20/200.

Methods

Study Design

• Phase II of SAHARA randomized controlled trial (RCT).
• SAHARA RCT was a multicenter, cross-over, RCT conducted across 11 states in the US.

Treatment Strategy

• During the phase II of the SAHARA RCT, all patients randomized to CsA (in phase I), discontinued CsA following the 6-month endpoint, and were treated with treatment care (TC) comprising of LHT.
• Patients were subsequently followed for an additional 6 months.

Outcomes

• Outcome measures at 12 months were: TBUT, OSDI and MGSS

  Results

• The final analysis included 161 patients (322 eyes).
• The TBUT improved from baseline to 6 months, with further improvement at 9 and 12 months.

Fig 1: Improvement in TBUT during the study

• Mean OSDI at baseline was 50.0, the same improved to 34.2 after CsA treatment. There was a further insignificant improvement in OSDI with LHT at 9 (30.0) and 12 (31.0) (P = 0.162 vs. month 6, P <0.0001 vs. baseline).
• The Symptom Assessment in Dry Eye questionnaire (SANDE) scores improved significantly after the cross over to LHT (46.10 at cross-over time vs. 37.75 and 40.29 at 3 and 6 months post cross over).
• The Eye Dryness Score (EDS) also improved after crossover (46.48 at the cross-over visit vs. 38.20 and 42.08 3 and 6 months post cross over) but was not statistically significant at six months after cross-over to TC.
• The MGSS improved significantly from baseline to end of the treatment (both P <0.001) (Fig. 2).

Fig 2: Improvement in MGSS during the study

The use of tear or lubricant products was low at months 1 (24%), 3 (23%), and 6 (30%) following the cross-over to TC, compared with 38% in the CsA arm in phase 1 of the study.

Conclusions

• Patients treated with CsA for 6 months can achieve meaningful additional improvement in signs and symptoms lasting for as long as 6 months following a single LHT treatment without the need for topical prescription therapy.

Clin Ophthalmol. 2024:18;1525–1534