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Rohto Dry Eye Relief (Figure 1) is a new alternative for the management of dry eyes, manufactured by The Mentholatum Company.
Rohto Dry Eye Relief (RDER) is a novel solution that contains a patented bi-polymer. Trade named HydraMed, this bi-polymer is formed from the cooperative interaction of two naturally occurring polysaccharides, hyaluronic acid (HA), and tamarind seed polysaccharide (TSP).1 The latter is a new polysaccharide to the UK, with muco-mimetic properties and is derived from the seed of the Tamarind tree. Table 1 shows the solution is available in multi-dose and, what the company describes as, a daily-dose unit (DDU). The DDU has a novel replaceable cap with data supporting the safety of its reuse within 12 hours.
Study format and protocol
During the winter of 2009-10, 10 UK-based practitioners participated in a practice-based study to evaluate the performance of RDER dry eye drops. This was not a true clinical trial more a real-world evaluation by both patient and practitioner, where the practitioner was free to select which patients were dispensed, albeit within the acceptance criteria of the study. The purpose of the study was to gather simple data supporting the efficacy and patient acceptance of the product.
Practitioner and patient questionnaires were used to gather data on the eye drop's performance. Apart from the obligatory discrete data, for ease of completion by both patient and practitioner, the forms were largely made up of statements that the completer simply had to rate their level of agreement or disagreement with on a five-point Linkert scale.
Each practitioner was asked to enter three or more patients into this study. Each subject was examined at the initial visit to determine eligibility. A patient was deemed eligible if they had one or more symptom (such as ocular dryness, grittiness or redness) or sign (such as a low TBUT) of a mild to moderate dry eye. Diagnosis of severe dry eye and contact lens wear were the primary exclusion criteria.
The investigating practitioners were randomly assigned either a 10ml multi-dose bottle or the 0.5ml DDU of the drop to evaluate, with the recommendation for the patient to use the drop 2-3 times a day. Only one follow-up visit was required and this was scheduled at an interval of 2-4 weeks after initial dispensing. Classification of clinical findings followed the Efron Grading Scale, but on a simpler 1-4 whole number scale. Two documents, the Practitioner Report Form and the Patient Questionnaire, had to be completed at both the initial (dispensing) and the follow-up visit.
Overview
Ten practices participated, supplying completed paperwork for the dispensing of RDER to a total of 39 patients. All multi-dose patients returned for follow-up with four DDU patients not returning, meaning follow-up data was submitted for 35 patients (70 eyes). Twenty-eight (82 per cent) of the patients seen at dispensing were female and 11 (18 per cent) were male. The mean age of the study participants was 61.2 years with the youngest recorded being 20 and the oldest 84.
Sixty-nine per cent of the patients entered into the study had previously used dry eye drops, with 61 per cent having used a multi-dose product and 39 per cent a unit-dose format. All patients who had previously used drops felt those drops provided some kind of relief 56 per cent of patients answered 'Yes' to the question 'Does using drops relieve your symptoms?' with 46 per cent stating they sometimes provided symptom relief. The type of drop was recorded for 17 patients and the variety of drops used immediately prior to dispensing RDER, as well as their prevalence can be seen in Figure 2 (note that some patients used more than one type of drop).
General performance
Initial comfort
Patients were asked to report any irritation they felt upon instillation of RDER. All patients reported that they had no discomfort upon drop instillation.
Symptoms
There were a range of dry eye related symptoms reported by patients at both dispensing and follow-up. Figure 3 shows the incidence of symptoms reported at both the dispensing and the follow-up appointment. At dispensing dryness, grittiness and itchy symptoms were most prevalent. There was a much lower reported incidence of all symptoms at the follow-up visit with more than a four-fold reduction in dryness symptoms. Twenty-five patients (64 per cent) reported dryness, among other symptoms, at dispensing. At the follow-up visit, having used RDER, only six patients (15 per cent) reported this symptom.
Figure 4 shows how the patient symptoms at the end of the day compared with pre-study. The question was asked at three different time points with the addition of early and middle of the day, and the majority of patients (ranging from 73 per cent to 83 per cent) reported RDER as better than their pre-study situation. Only one patient, and only at the end of day time point, stated their eyes felt worse.
Ocular comfort scores (OCS)
Patients were asked to ring the (whole) number that they felt best represented their ocular comfort on a visual analogue scale of 1-10, where 1 = extremely uncomfortable and 10 = completely comfortable. There was a mean improvement in ocular comfort score of 2.8 with the mean comfort score at dispensing being 5.4, improving to 8.2 following use of RDER. 91 per cent of users (32) rated their OCS with this drop as 7 or over.
Practitioner data
Clinical signs
The investigating practitioners were asked to record the clinical grading levels of four clinical signs, namely corneal staining, conjunctival staining, conjunctival redness and limbal redness, at both dispensing and follow-up. Most patients presented with either mild or none of these clinical signs. Overall there were no differences likely to be of clinical significance between the grading levels at dispensing or follow-up visits.
The investigators recorded their agreement with a series of statements for every patient followed up after using RDER. The practitioner opinions for seven statements for the 35 patients who completed the study can be seen below.
- RDER performed better than the patient's previous drop
Fifty-six per cent of investigator individual (patient) responses either strongly agreed or agreed with this statement. Thirty-three per cent either strongly disagreed (7 per cent) or disagreed (26 per cent) with this statement - RDER performed as well as I would have liked
Forty-three per cent of investigator individual (patient) responses either strongly agreed or agreed with this statement. Forty per cent of responses either strongly disagreed (9 per cent) or disagreed (31 per cent) with this statement - Patient relief with RDER was better than I expected
For this statement the most prevalent response was neutral at 43 per cent. Twenty-eight per cent of investigator individual (patient) responses agreed with this statement (none strongly agreed). Thirty-nine per cent of responses either strongly disagreed (3 per cent) or disagreed (36 per cent) with this statement - The use of a preservative didn't seem to affect the performance of the drop
In the preserved multi-dose bottle group, 90 per cent of investigator individual (patient) responses (including those who were neutral) felt that the preservative didn't negatively affect the performance of the drop - The patient complied with the daily disposal of the daily dose vial. In the DDU group 73 per cent of investigator individual (patient) responses to this statement either strongly agreed or agreed. There was no disagreement to this statement
- A re-sealable daily dose vial is an effective method of delivering a preservative free eye drop
In the DDU group 80 per cent of investigators individual (patient) responses to this statement either strongly agreed or agreed. Seven per cent disagreed and 13 per cent were neutral to this statement - I will recommend this patient continues to use RDER
Seventy-four per cent of the investigator individual (patient) responses stated that they would recommend the patient continued to use the new drop. One patient (3 per cent) remained using their previous drop (Figure 5).
Patient data
Both groups of patients felt RDER provided some kind of relief 75 per cent of patients answered 'Yes' to the question 'Does using drops relieve your symptoms?' compared with 56 per cent of users of other drops pre-participation in the study. 25 per cent stated that the study drop sometimes provided symptom relief. In addition to ocular comfort scores patients were asked whether RDER improved their eye comfort 75 per cent of patients answered a definitive 'Yes' with no patients answering 'No'.
Figure 6 shows the responses to the question 'What levels of relief did RDER generally provide your dry eye sensations during the day?' Patients could provide multiple answers to this question and it can be seen that all respondents felt that RDER provided relief, with six times more responses (12 vs 2 and 33 per cent of all responses) stating that the new drop provided long-term relief.
Following on from the previous question about the level of relief, an analysis of the breakdown of responses for how long RDER provided relief, shows that 59 per cent of patients responded that they got at least four hours' relief from the drop the single largest response being from the 35 per cent of patients who gained 6-8 hours of relief, followed by the 26 per cent achieving 4-6 hours.
Patients were asked about the dry eye symptoms they experienced and their prevalence during the day both at dispensing before using RDER and at the follow-up visit having used the new drop. Figure 7 shows data for symptom prevalence early in the day and late in the day. It can be seen that there is a trend for RDER users to experience symptoms less often at both times of the day. Of particular note is the 50 per cent of users who, following RDER use, had no symptoms early in the day, as well as the five-fold reduction (24 at dispensing vs five at follow-up) in patients reporting they often have symptoms late in the day.
Patients who had used drops before were then asked how their symptom relief compared with their previous drops. Eight out of 10 (n=35) patients felt RDER was better early in the day with no patients feeling their old drops were better. Late in the day 74 per cent (n=31) of patients felt the new drop was better with only one patient (3 per cent) feeling their old drop was better.
Like the investigators, the patients also recorded their agreement with a series of statements on their views following using RDER. The patients' opinions for six performance statements for the 35 patients who completed the study can be seen below:
- 'RDER rapidly soothes and moisturises my dry eyes' - 88 per cent of all patients strongly agreed (40 per cent) or agreed (48 per cent) with this statement. Only one patient disagreed (3 per cent strongly disagreed) with this proposition
- 'RDER provides rapid relief from dry, gritty eyes' - 82 per cent of all patients strongly agreed (43 per cent) or agreed (39 per cent) with this statement. Only one patient disagreed (3 per cent strongly disagree) with this proposition
- 'RDER does NOT significantly blur my vision after instillation' - 88 per cent of all patients strongly agreed (34 per cent) or agreed (54 per cent) with this statement. Only one (3 per cent) patient disagreed with this proposition
- 'RDER provides long lasting relief of my dry eye symptoms' - 63 per cent of all patients strongly agreed (23 per cent) or agreed (40 per cent) with this statement. 24 per cent were neutral and 14 per cent disagreed. No patients strongly disagreed with this proposition
- 'RDER is more effective than other dry eye drops I've tried' - out of the 22 responses to this question, 59 per cent of all patients strongly agreed (41 per cent) or agreed (18 per cent) with this statement (Figure 8). The single largest response was the 41 per cent who strongly agreed, with the next largest group being the 23 per cent who were neutral about the statement. Eighteen per cent of this group of patients disagreed (14 per cent) or strongly disagreed (4 per cent) with this proposition
- 'If my optician agreed, I would like to continue using RDER' - 88 per cent of all patients strongly agreed (47 per cent) or agreed (41 per cent) with this statement (Figure 9). Nine per cent (three patients) either disagreed (6 per cent) or strongly disagreed (3 per cent) with this proposition.
Value for money
Patients were asked to rate their level of agreement with the statement 'RDER is worth paying more for'. The overall result for both the 10ml and the DDU shows that 55 per cent of patients strongly agree (15 per cent) or agree (40 per cent) that RDER is worth paying more.
Interestingly there was a variation between responses for the two formats. The DDU divided opinion more than the 10ml format, with an increase to just over a fifth (21 per cent) of patients strongly agreeing that this format is worth paying more for. However, the number disagreeing with the proposition more than doubled to 22 per cent being the second most popular response.
Patients were also asked to rate their level of agreement with the statement 'RDER represents good value for money'. The overall result for both the 10ml and the DDU showed that 46 per cent of patients strongly agree (20 per cent) or agree (26 per cent) that RDER represents good value for money.
Again there was variation between the two formats the main difference between them is the number of patients who disagree with the proposition. Only 10 per cent of the 10ml users disagree (5 per cent) or strongly disagree (5 per cent) that this format represents good value for money. However, this increases to 20 per cent for DDU users, with 13 per cent strongly disagreeing and 7 per cent disagreeing that at a £1 premium, the daily disposal format represents good value for money.
Discussion
Dry eye studies are notoriously difficult and expensive to perform, with the gamut of tests available also less sensitive than researchers would ideally like. Many studies struggle to demonstrate any clinically or statistically significant improvement or differences between products.
Increasingly experts in the dry eye field advise practitioners to listen to their patients more when it comes to diagnosing dry eye. Patient symptomatology is important in helping understand the condition's likely cause and thus management. In the author's view is often more helpful than many of the quantitative tests that, if they are conclusive at all, at best simply confirm whether the eye is dry, rather than what might be the underlying problem.
As practitioners, we tend to be slightly sceptical of manufacturers' claims until we have 'tested' them for ourselves with our own patients. This paper reviews the experience of patients in the same 'real world' environment that any practitioner, who decides to trial a product in his or her practice, will experience. This kind of patient feedback is a valuable and perfectly valid way of evaluating the performance of a dry eye drop such as RDER.
As clinicians, we like to discuss our experiences and get the perspective of our peers, even though we know this is simply anecdotal. This post marketing field study provides UK practitioners with the views of 10 of their peers, as well as 35 of their patients using RDER on a random mix of mild to moderate dry eye patients, some with experience of using eye drops, that presented in their regular clinics. Thus, while not as scientific in its protocol as a study carried out in a research clinic, it mirrors the real world, making its results a valid indicator of product performance.
Conclusion
It can be seen that the results from both groups were generally positive towards RDER, with the responses from patients better (perhaps not surprisingly) than the naturally more conservative investigators. However all 10 practitioners agreed to stock the product as a result of their experience with it and, in all but one instance, weren't unhappy for any of their patients to continue to use it. Interestingly, and perhaps surprising in the light of current opinion, 90 per cent of the practitioner responses felt that the use of the preservative in the multi-dose bottle didn't negatively affect the performance of the drop.
Patients in the study were very positive about the benefit of using RDER, with all of them agreeing that it provided some kind of relief and three quarters responding with a definite 'Yes' to the question 'Did the drops relieve your dry eye symptoms?'. Certainly there was strong agreement that it provides both rapid relief, more than a four-fold reduction in dryness symptoms, a six-times increase in previous drop users saying it provided long-term relief and a five-fold reduction in patients reporting symptoms late in the day.
In commercial clinical practice, the final 'proof of the pudding' is purchase intent and perceived value for money, once the price of the product is known. These data were strong and particularly impressive was the fact that over half of the patients (55 per cent) also agreed that the performance of RDER was worth paying more for.
The technology behind dry eye preparations is improving all the time and the results of this post marketing field study suggest that RDER provides UK practitioners with another effective product to help them manage the increasing number of patients complaining of ocular dryness during their everyday lives. ?
Acknowledgements
The author and The Mentholatum Company would like to thank the following individuals for their support and diligence in carrying out this study: Ian Moss, Christine Ramsdale, Finlay Rosenburg, Ian Hickson. Kieran Minshull, Stephen Saum, Sarah Farrant and Kay Hilton.
Reference
1 Atkins N. Managing Dry Eye Disease (A Review of Rohto Dry eye Relief). Optician, 11.12.09 page 22-23.
? Nick Atkins is professional affairs and marketing consultant and director of positive impact