Clinical trial NCT02121847: Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of cyclosporine 0.05% ophthalmic emulsion (Restasis®) in patients with dry eye disease.


Eligibility criteria: Inclusion Criteria:

* History of dry eye in both eyes
* Willing to use eye drops for dry eye symptoms

Exclusion Criteria:

* Anticipate wearing contact lenses during the study
* Laser-assisted in situ keratomileusis (LASIK) surgery within the past 12 months
* Any ocular and/or lid surgeries within the past 6 months
* Cataract surgery in either eye
* Current or anticipated use of temporary punctal plugs during the study

Primary outcomes:
measure: Change From Baseline in Total Corneal Staining Score With Fluorescein in the Worse Eye
timeFrame: Baseline, Month 6
measure: Change From Baseline in Total Conjunctival Staining Score With Fluorescein in the Worse Eye
timeFrame: Baseline, Month 6
measure: Change From Baseline in Total Corneal Staining Score With Lissamine Green in the Worse Eye
timeFrame: Baseline, Month 6
measure: Change From Baseline in Total Conjunctival Staining Score With Lissamine Green in the Worse Eye
timeFrame: Baseline, Month 6
measure: Change From Baseline in Reading on the Ocular Surface Disease Index (OSDI)
timeFrame: Baseline, Month 6
measure: Change From Baseline in Driving at Night on the OSDI
timeFrame: Baseline, Month 6
measure: Change From Baseline in Working With a Computer or Bank Machine on the OSDI
timeFrame: Baseline, Month 6
measure: Change From Baseline in Watching TV on the OSDI
timeFrame: Baseline, Month 6
measure: Change From Baseline in Reading Rate
timeFrame: Baseline, Month 6
measure: Change From Baseline in Words Read Incorrectly
timeFrame: Baseline, Month 6
measure: Change From Baseline in Font Size
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Change From Baseline in OSDI
timeFrame: Baseline, Month 6
measure: Change From Baseline in Ocular Discomfort on a 4-point Scale
timeFrame: Baseline, Month 6
measure: Change From Baseline in Tear Film Break-up Time in the Worse Eye
timeFrame: Baseline, Month 6
measure: Change From Baseline in the Interblink Interval in the Worse Eye
timeFrame: Baseline, Month 6
measure: Change From Baseline in Conjunctival Redness in the Worse Eye
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Andover
country: United States
state: Massachusetts
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Stonecipher KG, Torkildsen GL, Ousler GW 3rd, Morris S, Villanueva L, Hollander DA. The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye. Clin Ophthalmol. 2016 May 13;10:887-95. doi: 10.2147/OPTH.S101627. eCollection 2016.