| A Prospective, Randomized, Placebo and Active Comparator Controlled Study of CP-690,550 in Subjects With Dry Eye. |
| A Phase I/II Prospective, Randomized, Double Masked, Vehicle And Comparator Controlled, Dose Ranging Study Of CP-690,550 In Subjects With Dry Eye Disease. |
| A prospective, randomized, placebo and active comparator controlled study of CP-690,550 in subjects with dry eye. |
| Not Provided |
| Interventional |
Phase 1
Phase 2 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment |
| Dry Eye Syndromes |
- Drug: CP-690,550
Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks
- Drug: CP-690,550
Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks
- Drug: CP-690,550
Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks
- Drug: CP-690,550
Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks
- Drug: Cyclosporine
Ophthalmic topical solution, 0.05%, dosed at least once/day, 8 weeks
- Drug: CP-690,550 Vehicle
Ophthalmic topical solution, dosed at least once/day, 8 weeks
|
- Experimental: Treatment 1
Intervention: Drug: CP-690,550
- Experimental: Treatment 2
Intervention: Drug: CP-690,550
- Experimental: Treatment 3
Intervention: Drug: CP-690,550
- Experimental: Treatment 4
Intervention: Drug: CP-690,550
- Active Comparator: Active comparator
Intervention: Drug: Cyclosporine
- Placebo Comparator: Placebo
Intervention: Drug: CP-690,550 Vehicle
|
- Liew MS, Zhang M, Kim E, Akpek EK. Prevalence and predictors of Sjogren's syndrome in a prospective cohort of patients with aqueous-deficient dry eye. Br J Ophthalmol. 2012 Dec;96(12):1498-503. doi: 10.1136/bjophthalmol-2012-301767. Epub 2012 Sep 21.
- Huang JF, Yafawi R, Zhang M, McDowell M, Rittenhouse KD, Sace F, Liew SH, Cooper SR, Pickering EH. Immunomodulatory effect of the topical ophthalmic Janus kinase inhibitor tofacitinib (CP-690,550) in patients with dry eye disease. Ophthalmology. 2012 Jul;119(7):e43-50. doi: 10.1016/j.ophtha.2012.03.017. Epub 2012 May 18.
- Liew SH, Nichols KK, Klamerus KJ, Li JZ, Zhang M, Foulks GN. Tofacitinib (CP-690,550), a Janus kinase inhibitor for dry eye disease: results from a phase 1/2 trial. Ophthalmology. 2012 Jul;119(7):1328-35. doi: 10.1016/j.ophtha.2012.01.028. Epub 2012 Apr 22.
|
| |
| Completed |
| 327 |
| October 2009 |
| October 2009 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Symptoms of dry eye for at least 6 months.
- Signs of moderate to severe dry eye
Exclusion Criteria:
- Women who are nursing or pregnant
- Participation in other studies within 30 days of screening visit
- Ocular disorders that may confound interpretation of study results
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| |
| NCT00784719 |
A3921034
A3921034 |
| No |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| February 2013 |
