Efficacy of "Aquoral Lipo" Artificial Tears in Contact Lens Wearers With Discomfort
Evaluation of the Efficacy of "Aquoral Lipo" Artificial Tears in Contact Lens Wearers With Discomfort Symptoms
Other study identifiers
Sponsor study identifier
interventional
41
1 country
1
Study Start
March 1, 2022
Actual (reported)Primary Completion
July 12, 2024
Actual (reported)Study Completion
July 12, 2024
Actual (reported)Brief Summary
There are more than 140 million contact lens wearers in the world. However, contact lens use can cause discomfort symptoms in up to 50% of wearers. And these symptoms can lead to contact lens abandonment in 12-51% of symptomatic wearers. Contact lens discomfort is defined by the Tear Film \& Ocular Surface Society (TFOS) as a condition characterized by episodic or persistent adverse ocular sensations related to contact lens wear, either with or without visual disturbance, resulting from reduced compatibility between the contact lens and the ocular environment, which can lead to decreased wearing time and discontinuation of contact lens wear. The most common cause of contact lens discontinuation is discomfort and dryness symptoms. This symptomatology is associated with visual acuity alterations, increased risk of ocular surface desiccation, or decreased contact lens wearing time. But the different signs found in contact lens wearers who present discomfort with contact lenses do not always correlate with the symptoms they report. In addition, different factors negatively impact contact lens discomfort such as low relative humidity environments. In order to alleviate contact lens discomfort, the first option chosen by professionals is fitting another contact lens with different replacement frequency or material. The second option is recommending the use of lubricants or moisturizers, and the third one is changing the maintenance system. The use of artificial tears is an effective way to improve contact lens discomfort, mainly by instilling them prior to contact lens insertion, since it provides the moisturizing factor that maintenance solutions lack. In addition, it improves comfort, visual quality, and reduces the production of deposits on the contact lens. The hypothesis of this clinical trial is that "Aquoral Lipo" artificial tears are more effective than control artificial tears to improve symptomatology in contact lens wearers with discomfort symptoms. The study will compare the effect of both "Aquoral Lipo" and control artificial tears under controlled normal and adverse environmental conditions.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Actual enrollment (reported)
- 41 participants
- Study completion date
July 12, 2024
Actual (reported)- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
February 22, 2022
Actual (reported)Study Start
March 1, 2022
Actual (reported)First Posted
March 22, 2022
Actual (reported)Primary Completion
July 12, 2024
Actual (reported)Study Completion
July 12, 2024
Actual (reported)
- Last Updated
- October 8, 2024
- Status Verified
- October 2024
- Last Update Submitted
- October 1, 2024