Evaluation of Comfort in Subjects With Moderate Dry Eye Disease

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Other: FID123238; Other: Systane Hydration

• Registration Number: NCT04830956
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate the comfort of an ocular lubricant in dry eye subjects. This study will be conducted in Canada and Australia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-01
• Study First Posted: 2021-04-05
• Study Start: 2021-06-30
• Status Verified: 2021-11
• Primary Completion: 2021-11-10
• Study Completion: 2021-11-10
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Able to understand and sign an information consent letter
• Willing and able to follow instructions and maintain the appointment schedule
• Has dry eye symptoms

Key

Exclusion Criteria

• Has suffered any ocular injury to either eye in the past 12 weeks
• Is pregnant or lactating at the time of enrollment

Other protocol-specified inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	Systane Hydration	FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.
Sequence 5	FID123238	FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.
Sequence 1	FID123238	FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.
Sequence 2	FID123238	FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.
Sequence 4	FID123238	FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.
Sequence 3	Systane Hydration	FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.
Sequence 1	Systane Hydration	FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.
Sequence 4	Systane Hydration	FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.
Sequence 3	FID123238	FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.
Sequence 5	Systane Hydration	FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.

Primary Outcome Measures

Name	Time	Method
Change from baseline in comfort rating	Baseline, up to 12 Hours (Day 1, each product)	A visual analogue scale will be used

Trial Locations

Locations (1)

Alcon Investigator 8169; 🇦🇺 Carlton, Victoria, Australia