RecruitingACTRN12618000326291

Evaluation of ocular signs and symptoms following contact lens wear

Evaluation of ocular signs and symptoms following two hours of contact lens wear of both silicone hydrogel and hydrogel lenses soaked in three multipurpose lens care solutions at three different intervals (1 day, 10 days and 30 days).


Sponsor

University of New South Wales

Enrollment

80 participants

Start Date

May 18, 2017

Study Type

Interventional

Conditions

Summary

To evaluate the ocular signs and symptoms following 2 hours of contact lens wear following soaking with 3 commercially available contact lens care multipurpose disinfectant solutions. Two types of lens materials will be used - a hydrogel lens (Etafilcon A) and silicone hydrogel lens (Comfilcon A). Both the dispensing investigators and the contact lens wearers will be masked.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether three commercially available contact lens cleaning and disinfecting solutions cause different levels of eye irritation or discomfort after wearing contact lenses for 2 hours. Both a soft hydrogel lens and a silicone hydrogel lens will be tested. Participants will not know which solution their lenses were soaked in. The study is looking for redness, dryness, and any other eye signs or symptoms to help identify the safest and most comfortable solutions for contact lens wearers. You may be eligible if: - You are 18 years or older - You have a refractive prescription (short-sightedness) between -1.00 and -8.00 - You have not previously worn contact lenses - You have no history of eye surgery or eye injury - You are able to understand English and give informed consent You may NOT be eligible if: - You have a pre-existing eye condition (including keratoconus or herpes keratitis) - You have a systemic disease affecting eye health (e.g. Grave's disease, epilepsy) - You are pregnant or breastfeeding - You are taking medications that may affect your eyes or reduce tear production Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

In this double masked, contralateral design study, participants will be administered (by a final year optometry student) with hydrogel or silicone hydrogel lenses soaked in either one of the 3 diffe

In this double masked, contralateral design study, participants will be administered (by a final year optometry student) with hydrogel or silicone hydrogel lenses soaked in either one of the 3 different contact lens care solutions; Biotrue, RevitaLens OcuTec and Opti-free PureMoist. All the contact lens and lens care solutions are available in the Australian market for use. Following soaking for either 1, 10 or 30 days, the lenses will be worn by one eye of the human participants. The other eye will wear a lens of the same material that was soaked in sterile buffered saline solution (control). Both the lenses will look same, neither the participant nor examiner (Stage 5 optometry student under guidance of qualified optometrist) will know which eye is allocated for the control/MPS-soaked lens. The lens allocation will be assigned by a clinical research coordinator. The lens will remain in the participant’s eye for 2 hours, after which visual acuity will be measured and ocular signs and symptoms evaluated using slit lamp biomicroscopy, Oculus Keratograph and Lipiview imaging instruments. Each participant is expected to be evaluated at 9 different visits, for 3 different MPS solutions at 3 different time points of lens-solution soaking with at least 48 hours washout period in between visits. Participants will receive same type of lens for every visit.


Locations(1)

NSW, Australia

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ACTRN12618000326291