Discrepancies in clinical trial patient assessments a hurdle in contact lens comparisons
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Key takeaways:
- None of the trials reported CLDEQ-8 or SPEED scores.
- Researchers recommend standardization of comfort and safety assessments in clinical trials.
Lack of standardization in comfort and safety assessments makes it difficult to compare silicone hydrogel and hydrogel contact lenses, according to a recent review.
In a systematic review published in both Optometry & Vision Science and Cochrane Database of Systematic Reviews, researchers examined several databases to identify randomized clinical trials that compared the comfort and safety of silicone hydrogel and hydrogel soft contact lenses. Seven studies met the eligibility criteria and included a total of 1,371 participants (average age, 20.7-33 years; 55%-75% women) with a median of 120 participants per trial.
“I think that most doctors will find it very surprising that silicone hydrogel and hydrogel contact lenses are similar with respect to safety and comfort,” study author Andrew D. Pucker, OD, MS, PhD, FAAO, executive director of clinical and medical science at Lexitas, told Healio. “If anything, it might be slightly riskier long-term to wear silicone hydrogel contact lenses given that they have been found to be more likely to result in infiltrative events compared to hydrogel contact lenses. This is in direct contrast to most people’s beliefs ... that the more breathable silicone hydrogel contact lenses are safer than traditional hydrogel contact lenses.”
Five trials examined soft contact lenses, and, of those, three enrolled new wearers and two enrolled both new and experienced wearers. The trials included eight different silicone hydrogel contact lenses and three hydrogel soft contact lenses, with the duration of wear ranging from 1 week to 52 weeks.
According to researchers, none of the trials reported Contact Lens Dry Eye Questionnaire (CLDEQ)-8 or Standard Patient Evaluation of Eye Dryness scores. One trial included estimates for the mean difference in Ocular Surface Disease Index scores, which were –1.2 at 1 month and 1.43 at 3 months, although the certainty of evidence was low. Five trials examined reasons for withdrawal, but none specified lens discontinuation as an outcome.
Visual analog scale comfort scores were reported in three trials, although there were no significant difference in ratings. Similarly, researchers reported little to no difference in corneal staining, conjunctival staining, conjunctival redness or vision-threatening adverse events among lenses, although the risk for adverse events may be lower with long-term use of hydrogel contact lenses.
“My biggest wish for the community is to start standardizing the primary tests used in clinical trials by indication,” Pucker said. “For example, the CLDEQ-8 is a common, validated and accepted metric for evaluating contact lens satisfaction, yet none of the included trials used the CLDEQ-8. This inconsistency makes it challenging to compare studies or products, which ultimately makes it challenging for practitioners to know what to recommend to their patients.”
Reference:
- Haworth K, et al. Cochrane Database Syst Rev. 2023;doi:10.1002/14651858.CD014791.pub2
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Travis D, et al. Optom Vis Sci. 2024;doi:10.1097/OPX.0000000000002161.
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