Evaluation of Comfort of Ocular Lubricants in Symptomatic Contact Lens Wearers

Alcon

Status: Completed

Conditions: Dry Eye

Treatments: Other: OTF Ocular Lubricant; Other: Ocular Lubricant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05741216

DEJ475-E006

Details and patient eligibility

About

The purpose of this study is to evaluate the ocular comfort of 3 ocular lubricants and a comparator.

Full description

The expected duration of subject participation is at least 7 days. This study will be conducted in Australia and Canada.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Is able to understand and sign an approved information consent letter;
• Habitually wears daily disposable soft contact lenses in both eyes
• Uses rewetting drops on a regular basis;
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Routinely sleeps in habitual contact lenses;
• Has any known active ocular disease and/or infection;
• Is pregnant or lactating;
• Other protocol specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

OTF Test 1

Experimental group

Description:

One application of ocular lubricant to each eye at night for 5 consecutive nights

Treatment:

Other: OTF Ocular Lubricant

OTF Test 2

Experimental group

Description:

One application of ocular lubricant to each eye at night for 5 consecutive nights

Treatment:

Other: OTF Ocular Lubricant

OTF Test 3

Experimental group

Description:

One application of ocular lubricant to each eye at night for 5 consecutive nights

Treatment:

Other: OTF Ocular Lubricant

Ocular lubricant

Active Comparator group

Description:

One drop of ocular lubricant applied to each eye at night for 5 consecutive nights

Treatment:

Other: Ocular Lubricant