A Study to Compare a New Eye Drop Formulation With Systane® Gel Drops and Genteal® Lubricant Gel Drops for Moderate to Severe Dry Eye Relief

Dry Eye Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455050
• Other study ID #: 11193X-002
• Status: Completed
• Phase: Phase 3
• First received: January 22, 2015
• Last updated: December 30, 2015
• Start date: December 2014
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A study to evaluate the tolerability and acceptability of an investigational eye drop formulation in patients with Dry Eye Disease.

Other known NCT identifiers

• NCT02343900

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Current use of an artificial tear product

• Visual Acuity of at least 20/40 (while wearing glasses, if necessary).

Exclusion Criteria:

• Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study

• Cataract surgery, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy within 6 months

• Use of RESTASIS® Cyclosporine Ophthalmic Emulsion or any topical cyclosporine within 3 months

• Diagnosis of glaucoma.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Carboxymethylcellulose Sodium Based Eye Drops
1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops [New Eye Drop Formula] in each eye.
• Systane® Gel Drops
1 to 2 drops of Systane® Gel Drops in each eye.
• Genteal® Lubricant Gel Drops
1 to 2 drops of Genteal® Lubricant Gel Drops in each eye.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS)		Day 21	No
Primary	Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS)		Day 42	No
Secondary	Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale		Days 21 and 42	No
Secondary	Acceptability Survey Score Using a 5-Point Scale		Days 21 and 42	No
Secondary	Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale		Days 21 and 42	No
Secondary	End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms		Day 42	No
Secondary	Distance Visual Acuity		Days 21 and 42	No
Secondary	Tear Break-Up Time with Fluorescein		Days 21 and 42	No
Secondary	Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms		Days 21 and 42	No

External Links

•   More Information