Efficacy of "Aquoral Lipo" Artificial Tears in Contact Lens Wearers With Discomfort

NCT05290727 | Completed

• 1 other identifier: IOBA-2021-54
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Contact Lens Complication

Keywords

Contact lens; Discomfort; Artificial tears

Outcome Measures

Primary Outcomes (1)

• The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)

  Significant changes of at least 3 points in the questionnaire between the two products (study and control). This questionnaire quantifies the symptoms of ocular discomfort during the use of contact lenses. Values up to 37 points are obtained, with higher values representing greater symptomatology.

  After the use of the study product (15 days from treatment start)

Secondary Outcomes (13)

• The CLDEQ-8

  After the use of the study product (15 days from treatment start)

• The Contact Lens Discomfort Index

  After the use of the study product (15 days from treatment start)

• Comfort and dryness Visual Assessment Scales

  After the use of the study product (15 days from treatment start)

• Tear film stability

  After the use of the study product (15 days from treatment start)

• Tear film evaporimetry

  After the use of the study product (15 days from treatment start)

Other Outcomes (2)

• Visual acuity

  45 days after screening visit

• Presence of ocular or periorbital adverse events

  45 days after screening visit

Study Arms (2)

0.15% Aquoral Lipo (Esteve) and 0.15% Hyabak (Thea)

OTHER

Dosage form: topical administration multidose ophthalmic eye drops Product usage order will be determined through randomization Duration: 15 days + 15 days Frequency: dosage between 3 and 6 drops per day

Other: Aquoral Lipo (Esteve); Other: Hyabak (Thea)

0.15% Hyabak (Thea) and 0.15% Aquoral Lipo (Esteve)

OTHER

Dosage form: topical administration multidose ophthalmic eye drops Product usage order will be determined through randomization Duration: 15 days + 15 days Frequency: dosage between 3 and 6 drops per day

Other: Aquoral Lipo (Esteve); Other: Hyabak (Thea)

Interventions

Aquoral Lipo (Esteve) OTHER

15-day randomized treatment period of each of the clinical trial products (experimental and control) with a 1-week washout period prior to use of the study products

Also known as: 0.15% Hyaluronic Acid crosslinked with liposomes and crocin

0.15% Aquoral Lipo (Esteve) and 0.15% Hyabak (Thea); 0.15% Hyabak (Thea) and 0.15% Aquoral Lipo (Esteve)

Hyabak (Thea) OTHER

15-day randomized treatment period of each of the clinical trial products (experimental and control) with a 1-week washout period prior to use of the study products

Also known as: 0.15% Hyaluronic Acid

0.15% Aquoral Lipo (Esteve) and 0.15% Hyabak (Thea); 0.15% Hyabak (Thea) and 0.15% Aquoral Lipo (Esteve)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Signature of informed consent form
• Regular hydrophilic contact lens wearers: at least 4 times a week and at least 4 hours a day
• Contact lens discomfort measured as a Contact Lens Dry Eye Questionnaire-8 score higher than 11 points

You may not qualify if:

• Known sensitivity or intolerance to some of the products used in the study
• Habitual non-compliance of the contact lens replacement frequency
• Any systemic disease or treatment that alters the eye
• Any ocular surgery, infection, inflammation, or active eye disease, in the last year
• Autoimmune dry eye
• Participation in a clinical trial within 30 days prior to entry into this study
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA: lead
• Esteve: collaborator

Study Sites (1)

IOBA - University of Valladolid

Valladolid, 47011, Spain

Location

MeSH Terms

Interventions

hylan; Liposomes; crocin; Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Membranes, Artificial; Biomedical and Dental Materials; Drug Carriers; Dosage Forms; Pharmaceutical Preparations; Manufactured Materials; Technology, Industry, and Agriculture; Biomimetic Materials; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study and control products will lack any identification label, except that concerning the assignment code. The product together with the instillation instructions will be delivered in a sealed envelope which will contain an identification label of the assignment code.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Low intervention level, prospective, crossover, double masked, randomized, single center clinical trial

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 22, 2022
• Study Start: March 1, 2022
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

ES (1)