A Safety and Efficacy Study of OPTIVE FUSION™ With VISMED® Multi for the Management of Dry Eye

Allergan

Status and phase: Completed; Phase 4

Conditions: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Treatments: Drug: sodium hyaluronate 0.18%; Drug: carboxymethylcellulose 0.5%/glycerin 0.9%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02117687

MAF-AGN-OPH-DE-016

Details and patient eligibility

About

This study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi for the management of dry eye.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Use of artificial tears for dry eye in both eyes for at least 3 months
• Use of preservative-free artificial tears at least twice daily for 2 weeks;

Exclusion criteria

• Cataract, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK) surgery in the last 12 months
• Use of punctal plugs or contact lenses in the last month
• Active ocular allergy within last 2 years
• Best corrected visual acuity (BCVA) less than 20/200 in either eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

OPTIVE FUSION™

Active Comparator group

Description:

1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.

Treatment:

Drug: carboxymethylcellulose 0.5%/glycerin 0.9%

VISMED® Multi

Active Comparator group

Description:

1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.

Treatment:

Drug: sodium hyaluronate 0.18%