Phase 4 N=40 Treatment

Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy

Dry Eye Syndromes

Bottom Line

View on ClinicalTrials.gov: NCT02121847 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Apr 2016

Primary outcome: Primary: Change From Baseline in Total Corneal Staining Score With Fluorescein in the Worse Eye — 7.29; -1.96 Scores on a Scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: cyclosporine 0.05% ophthalmic emulsion (Drug); carboxymethylcellulose-based lubricant eye drops (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Sep 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Total Corneal Staining Score With Fluorescein in the Worse Eye	7.29; -1.96	—
PRIMARY Change From Baseline in Total Conjunctival Staining Score With Fluorescein in the Worse Eye	4.68; 0.11	—
PRIMARY Change From Baseline in Total Corneal Staining Score With Lissamine Green in the Worse Eye	4.43; -0.93	—
PRIMARY Change From Baseline in Total Conjunctival Staining Score With Lissamine Green in the Worse Eye	4.21; 0.30	—
PRIMARY Change From Baseline in Reading on the Ocular Surface Disease Index (OSDI)	1.4; -0.7	—
PRIMARY Change From Baseline in Driving at Night on the OSDI	2.3; -0.5	—
PRIMARY Change From Baseline in Working With a Computer or Bank Machine on the OSDI	2.2; -1.0	—
PRIMARY Change From Baseline in Watching TV on the OSDI	1.7; -0.8	—
PRIMARY Change From Baseline in Reading Rate	105.2; 3.5	—
PRIMARY Change From Baseline in Words Read Incorrectly	0.4; 0.2	—
PRIMARY Change From Baseline in Font Size	12.0; -0.2	—
SECONDARY Change From Baseline in OSDI	47.0; -19.7	—
SECONDARY Change From Baseline in Ocular Discomfort on a 4-point Scale	2.85; -1.30	—
SECONDARY Change From Baseline in Tear Film Break-up Time in the Worse Eye	1.55; 0.92	—
SECONDARY Change From Baseline in the Interblink Interval in the Worse Eye	4.18; 3.04	—
SECONDARY Change From Baseline in Conjunctival Redness in the Worse Eye	2.06; -0.03	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02121847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.