New topical treatment for CL discomfort

Contact lens discomfort (CLD) is a common and frustrating problem for both contact lens wearers and practitioners. While it may present as symptoms in the absence of signs, it may also be associated with signs of meibomian gland dysfunction (MGD)^1,2, contact lens-induced papillary conjunctivitis (CLPC)³ or ocular surface staining related to lens fitting, lens edge, lid-related friction or care solution interactions with the ocular surface (Fig 1)⁴. These possible factors may occur in isolation or in combination with each other.

Where CLD is accompanied by signs of MGD, there is evidence that managing MGD results in an increase in the duration of comfortable CL wear and an improvement in lid and meibomian gland signs. Two recent papers described the treatment of CLD in wearers with MGD in phase 1 and phase 2 safety and efficacy studies using a novel selenium disulphide ointment designed for the treatment of MGD^5,6.

The active ingredient in anti-dandruff shampoo, selenium disulphide acts as a keratolytic and increases sebum production by the sebaceous glands⁷ in the scalp, which is why sufferers of dandruff sometimes experience oily hair after anti-dandruff shampoo treatment. Meibomian glands are modified sebaceous glands and MGD is thought to involve both hyperkeratinisation causing blockage of the gland ducts and orifices and abnormal lipid production, which likely impacts tear stability⁸. Relevant MGD mechanisms may therefore be targeted by selenium disulphide.

Fig 1 (4) — Fig 1. Factors likely to contribute to CLD

A recent phase 2 study examined the efficacy of 0.5% selenium disulphide topical treatment in a non-CL-wearing population with signs of MGD and symptoms of dry eye disease (DED)^9,10. In brief, 267 participants were randomised to receive either the active ointment (0.5% selenium disulphide) or the vehicle alone, administered twice weekly to the lower eyelid margin before bedtime. Eyelid signs and symptoms were evaluated regularly over a six-month period.

In those with MGD, significant improvements were observed in the number of meibomian glands yielding liquid secretion/meibum (MGYLS) and in subjective comfort scores at month six compared with vehicle.

So, was there a benefit for this intervention in CL wearers with CLD and MGD?

In a similar study design, two groups of wearers with CLD, who were unable to wear lenses for as long as they wished, were recruited. The phase 1 study for safety and efficacy involved 15 participants, while the phase 2 study to demonstrate proof of principle involved 80 participants. Outcome measures were the number of meibomian glands yielding liquid secretion (MGYLS; lower scores indicate more severe MGD), meibomian gland secretion score (MGS; lower scores indicate more severe disease) and the duration of comfortable wear time. No other treatments were permitted.

Fig 2 shows the change from baseline in MGYLS (A), MGS (B), comfortable CL wear time (C) and the proportion of participants who could wear their CLs for as long as they wished (D), over a three-month period of use from the phase 2 study.

Fig 2 (4) — Fig 2: Change from baseline in MGYLS (A), MGS (B), comfortable CL wear time (C) and the proportion of participants who could wear their CLs for as long as they wished (D), over a three-month period of use from the phase 2 study.

Lid signs were significantly improved in the 0.5% selenium disulphide treatment group compared with both baseline and vehicle from the one-month timepoint and benefits were maintained or improved for the remainder of the three months of use. Patient benefit was evidenced by an increase in comfortable wear time after 1.5 months and almost half of participants by three months were able to wear their CLs as long as they desired.

In summary, a novel 0.5% selenium disulphide topical treatment is a safe, effective and well tolerated treatment for MGD, with significant wearer benefit in symptomatic CL wearers with MGD. This new treatment, requiring application just twice weekly, improves meibum secretions and reduces discomfort, enabling a greater proportion of CL wearers to wear their lenses for as long as they desire.

References

1. Korb DR, Henriquez AS. Meibomian gland dysfunction and contact lens intolerance. J Am Optom Assoc. 1980;51(3):243-251.

2. Arita R, Fukuoka S, Morishige N. Meibomian Gland Dysfunction and Contact Lens Discomfort. Eye Contact Lens. 2017;43(1):17-22.

3. Tagliaferri A, Love TE, Szczotka-Flynn LB. Risk Factors for Contact Lens–Induced Papillary Conjunctivitis Associated With Silicone Hydrogel Contact Lens Wear. 2014;40(3):117-122.

4. Stapleton F, Bakkar M, Carnt N, et al. BCLA CLEAR - Contact lens complications. Contact Lens and Anterior Eye. 2021;44(2):330-367.

5. Stapleton F, Hinds M, Tan J, et al. AZR-MD-001 0.5% selenium sulfideophthalmic ointment for the treatment of contact lens discomfort: A vehicle-controlled, randomized, clinical trial. The Ocular Surface. 2024.

6. Stapleton F, Jia T, DePuy V, Bosworth C, Gleeson M, Tan J. The effect of a biweekly novel selenium sulfide-containing topical treatment in symptomatic contact lens wearers: An exploratory study. The Ocular Surface. 2025;36:190-197.

7. Mitchell SC, Nickson RM, Waring RH. The Biological Activity of Selenium Sulfide. Sulfur Reports. 1993;13(2):279-289.

8. Nichols JJ, Willcox MD, Bron AJ, et al. The TFOS International Workshop on Contact Lens Discomfort: executive summary. Invest Ophthalmol Vis Sci. 2013;54(11):TFOS7-TFOS13.

9. Downie LE, Craig JP, Stapleton F, et al. Efficacy and safety of AZR-MD-001 selenium sulphide ophthalmic ointment in adults with meibomian gland dysfunction over six months of treatment: A Phase 2, vehicle-controlled, randomized extension trial. The Ocular Surface. 2025;35:15-24.

10. Watson SL, Jones LW, Stapleton F, et al. Efficacy and safety of AZR-MD-001 selenium sulfide ophthalmic ointment in adults with meibomian gland dysfunction: A vehicle-controlled, randomized clinical trial. Ocul Surf. 2023;29:537-546.

Scientia Professor Fiona Stapleton is a clinical teaching director and head of the Eye Research Group at the School of Optometry and Vision Science at UNSW Sydney. She has participated as part of the leadership group and as subcommittee chair for five of the previous TFOS workshops and leads both laboratory and clinical projects in ocular surface disease.

Associate Professor Jacqueline Tan is director of the Eye Research Group at the School of Optometry and Vision Science at the University of New South Wales, Sydney, where she leads a passionate team conducting contract clinical trial research. Her research has led to the regulatory approval of contact lens designs including lenses to correct for astigmatism, presbyopia and myopia control, as well as several novel treatments for dry eye.