| A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease |
| A Phase II, Prospective, Randomized, Double Masked/Investigator Masked, Vehicle And Comparator (Sodium Hyaluronate Eye Drops) Controlled, Dose Ranging Study Of CP-690,550 Eye Drops In Subjects With Dry Eye Disease |
| The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye drops in patients with dry eye disease. |
| Not Provided |
| Interventional |
| Phase 2 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment |
| Dry Eye Syndromes |
- Drug: CP-690,550 Eye drops
Ophthalmic topical solution, low dose, dosed once/day, 8 weeks
- Drug: CP-690,550 Eye drops
Ophthalmic topical solution, medium dose, dosed once/day, 8 weeks
- Drug: CP-690,550 Eye drops
Ophthalmic topical solution, high dose, dosed once/day, 8 weeks
- Drug: CP-690,550 Eye drops-vehicle
Ophthalmic topical solution, vehicle, dosed once/day, 8 weeks
- Drug: Sodium Hyaluronate
Ophthalmic topical solution, dosed 6 times/day, 8 weeks
|
- Experimental: Treatment 1
Intervention: Drug: CP-690,550 Eye drops
- Experimental: Treatment 2
Intervention: Drug: CP-690,550 Eye drops
- Experimental: Treatment 3
Intervention: Drug: CP-690,550 Eye drops
- Placebo Comparator: Treatment 4
Intervention: Drug: CP-690,550 Eye drops-vehicle
- Active Comparator: Treatment 5
Intervention: Drug: Sodium Hyaluronate
|
| Not Provided |
| |
| Completed |
| 285 |
| April 2011 |
| April 2011 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Subjective symptoms of dry eye for at least 6 months
- Signs of moderate to severe dry eye (corneal staining score and schirmer test without anesthesia)
Exclusion Criteria:
- Women who are nursing, pregnant or planning pregnancy during the study
- Participation in other studies within 30 days of screening visit
- Ocular disorders that may confound interpretation of study results
|
| Sexes Eligible for Study: |
All |
|
| 20 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Japan, Korea, Republic of |
| |
| |
| NCT01135511 |
| A3921072 |
| No |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| March 2013 |
