Clinical trial NCT02455050: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-05-27
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1
timeFrame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14)
measure: Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2
timeFrame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35)
Secondary outcomes:
measure: Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1
timeFrame: Baseline and after 14 days of treatment in Period 1 (Follow-up 1 Day 14)
measure: Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2
timeFrame: Baseline and after 14 days of treatment in Period 2 (Follow-up 2 Day 35)
measure: Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1
timeFrame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14)
measure: Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2
timeFrame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35)
measure: Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1
timeFrame: Baseline and After 14 days of treatment in Period 1 (Follow-up 1 Day 14)
measure: Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2
timeFrame: Baseline and After 14 days of treatment in Period 2 (Follow-up 2 Day 35)
measure: Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®)
timeFrame: Day 35
measure: Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®)
timeFrame: Day 35
measure: Distance Visual Acuity in Period 1
timeFrame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation
measure: Distance Visual Acuity in Period 2
timeFrame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation
measure: Tear Break-Up Time With Fluorescein in Period 1
timeFrame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation
measure: Tear Break-Up Time With Fluorescein in Period 2
timeFrame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation
measure: Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1
timeFrame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation
measure: Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2
timeFrame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation
Other outcomes:
Locations:
city: Azusa
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: