Evaluation of the Safety and Tolerability of Ocular Lubricants

Alcon

Status: Enrolling

Conditions: Dry Eye Disease

Treatments: Other: FID121843 ocular lubricant; Other: FID123360 test formulation; Other: FID123361 test formulation; Other: FID123359 test formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT06571656

DEE253-E002

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of three new artificial tear formulations in subjects with moderate dry eye disease.

Full description

This study will be conducted in 2 stages. In Stage 1, subjects will attend a total of 10 scheduled visits: one Screening visit, four Investigational Product visits, four 12-hour Follow Up visits (one for each Investigational Product visit), and an Exit visit. At each Investigational Product visit, subjects will receive one drop of the investigational product in each eye (2 drops total), as randomized. The first Investigational Product visit will occur 1 to 7 days after the Screening visit. A washout period of 2 to 7 days will separate each Investigational Product visit. Total individual duration of participation in Stage 1 will be 8 to 34 days. The planned enrollment for Stage 1 is 72 subjects.

At the conclusion of Stage 1, an interim analysis will be conducted to help determine potential adaptations to the study design for Stage 2.

This study will be conducted in Australia.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Willing and able to understand and sign an Ethics Committee-approved informed consent form.
• Willing and able to attend all study visits as required by the protocol.
• Exhibits symptoms of dry eye at the Screening Visit.
• Currently uses habitual artificial tears to alleviate dry eye symptoms.
• Willing and able to maintain similar environmental conditions throughout the study (for example, avoid extreme changes in humidity/temperature, avoid windy conditions) and refrain from swimming on Investigational Product visit days.
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Has any known active ocular disease and/or infection.
• Has any known infection or inflammation that requires treatment or has a systemic condition that in the opinion of the investigator, may affect a study outcome variable.
• Has had an ocular injury to either eye in the past 12 weeks prior to screening.
• Currently wears contact lenses or has a history of contact lens wear within the previous 1 month.
• Has undergone any ocular surgery (including intraocular surgery) within the past 12 months or has any ocular surgery planned during the study.
• Is pregnant, intends to become pregnant, or is breastfeeding.
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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72 participants in 4 patient groups

Sequence 1

Other group

Description:

FID123359/ FID123360/ FID123361/FID121843: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled.

Treatment:

Other: FID123359 test formulation

Other: FID123361 test formulation

Other: FID123360 test formulation

Other: FID121843 ocular lubricant

Sequence 2

Other group

Description:

FID123360/ FID123361/FID121843/ FID123359: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled.

Treatment:

Other: FID123359 test formulation

Other: FID123361 test formulation

Other: FID123360 test formulation

Other: FID121843 ocular lubricant

Sequence 3

Other group

Description:

FID123361/FID121843/FID123359/ FID123360: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled.

Treatment:

Other: FID123359 test formulation

Other: FID123361 test formulation

Other: FID123360 test formulation

Other: FID121843 ocular lubricant

Sequence 4

Other group

Description:

FID121843/FID123359/ FID123360/ FID123361: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled.

Treatment:

Other: FID123359 test formulation

Other: FID123361 test formulation

Other: FID123360 test formulation

Other: FID121843 ocular lubricant